Agenda
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Basel, 30 September 2025 - 2 October 2025
Schedule
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Chair's opening remarks
Achieving Sustainability in the Biologics Market
WuXi XDC: Novel Conjugation and Payload-linker Technologies to Empower Next-generation ADCs
1. WuXiDARx (x= 1, 2, 4, 6) conjunction technologies enable highly homogeneous ADCs without engineering mAbs or applying enzymes, achieving D1 > 90% using WuXiDAR1, D2 > 95% using WuXiDAR2, D4 > 70% - 85% using WuXiDAR4, and D6 > 80% using WuXiDAR6.
2. Application of WuXiDARx beyond traditional ADCs :
DAR1 AOC without engineering mAbs
Dual-payload ADCs with flexible formats(4+4; 2+4; 2+6) using traditional payload-linkers.
3. WuXiTecan-1 and WuXiTecan-2, the proprietary payload-linker (PL) technologies of WuXi XDC, enable next-generation ADCs with a wider therapeutic window, which is crucial for improving the efficacy and safety of ADCs.
The Digital Advantage
Antibody-based product successes and progresses in 2025
Biomarkers in clinical trials and clinical practice – why one biomarker is usually not enough
Biosimilars Development 2025 and Beyond: Coming Full Circle
Biosimilar streamlined development: returning to the roots of the “stepwise approach”
Paradigm of medicinal chemistry: structure determines function (not the other way around)
What we knew all along, but were hesitant to accept: analytics tell the story well (the clinic need not)
Why differential immunogenicity was never the problem it was made out to be.
Moving the adoption needle, bit by bit, step by step (working together to succeed together)
The biosimilar future: purposefully fit, fit for purpose (the beginning of a new era)
Bringing Medicine Development to patients, the why and the how
Systems biology approaches in improving quality and titer of biologics
Accelerated and Robust Cell Line Development in HEK293 Cells for Increased Protein Yields and Improved Protein Quality
Senior Representative, ExcellGene
KojoX - A Transformative Operational Ecosystem Delivering Flexible Manufacturing Strategies and Security of Supply
Leveraging Biologics manufacturing capacity for supply of life impacting or saving medicine is the key to a flexible supply chain that can respond to unforeseen demand changes. FUJIFILM Biotechnologies’ kojoX™ operational ecosystem is transforming the CDMO industry, delivering across a globally harmonized network and over a range of scales. KojoX is founded on using standardized infrastructure and processes to enable rapid transfer and production of medicines across one global network. However, the constantly evolving landscape driven by scientific and technological advances requires flexibility within this kojoX framework.
The presentation will outline the tools and strategies Fujifilm deploy to integrate current ways of working with innovation activities to ensure future technical solutions and processing strategies can be effectively and efficiently deployed into the kojoX ecosystem to solve today’s challenges as well as future patient needs.
Paradigm Shift in the Regulatory Requirements for Development of Biosimilars: Streamlined Clinical Development Offers Huge Opportunities
- EMA published in April a reflection paper on a tailored clinical approach in biosimilar development which outlines how in future development requirements of biosimilars will look like
- FDA so far dit not publish general guidance or concepts, however project specific advices on the basis of a sound scientific rational and thorough data point into a similar direction
- There is obviously a paradigm shift in the regulatory requirements for development of biosimilars
- Chances and opportunities will be discussed using the example of a pembrolizumab biosimilar
Protecting healthy volunteers in clinical trial - The VolREthics initiative.
Healthy volunteersplay a vital role in advancing science and medicine through their participation in research studies. Their contribution is especially well recognized in the early stages of medicinal product development and pharmacokinetic studies. However, their motivations, the risks they face, and the ethical issues involved can vary significantly depending on the context. The Global Charter developed by the VOLRETHICS initiative seeks to strengthen the protection of healthy volunteers, particularly in relation to the risks of harm, exploitation, and compromised well-being.
Genetic engineering strategies to eliminate lactate production and control ammonia secretion
Accelerating the Development and Manufacturing of Biologics
Biosimilars Keynote Panel
Optimising poloxamer 188 for CHO and HEK suspension cells for reduced batch-to-batch variation
The bioprocessing industry utilises Poloxamer 188 as a surfactant in parenteral biological formulations and as a shear stress protectant in cell culture. Poloxamer 188 is a non-ionic block copolymer with a hydrophobic polypropylene oxide (PPO) chain that is flanked by two hydrophilic polyethylene oxide (PEO) blocks. This unique molecular arrangement enables it to significantly reduce cell shear stress, which is essential for maintaining cell viability and overall health—a vital component in the successful production of biomolecules. However, the presence of impurities introduced during the manufacturing process can negatively compromise the functionality of Poloxamer 188 and adversely affect cell health, contributing to inconsistencies in performance between different production batches. Therefore, this inconsistency presents a persistent challenge in the bioprocessing market. As the demand for high-performance, batch-consistent cell culture ingredients continues to grow, Croda Pharma recently introduced Super Refined™ Poloxamer 188. Specifically optimised for cell culture, Super Refined™ Poloxamer 188 delivers excellent performance with tightly controlled impurity profiles, thereby reducing the risk of variable cell performance across different batches. To validate the efficacy of this innovative product, in this study we showed its exceptional performance in cell viability in both Chinese Hamster Ovary (CHO) and Human Embryonic Kidney (HEK) suspension lines. Furthermore, our study provides robust data that emphasises the batch-to-batch consistency of Super Refined™ Poloxamer 188, along with comprehensive analytical information that details its composition and impurity profile. As the need for reliability and batch-to-batch consistency of bioprocessing materials becomes increasingly evident, we believe Super Refined™ Poloxamer 188 will prove to be an exciting solution in this field.
Automated bioinformatics pipelines for rapid in silico analysis – In silico antibody assessment selection
Senior Representative, PipeBio, a Benchling Company
Solving the complexities of biologics clinical and commercial manufacturing — A unified CDMO approach
Bringing a biologic therapy from clinical development to commercial success is an increasingly complex and high-stakes journey. For many biopharma companies, the process is burdened by fragmented processes, repeated tech transfers, regulatory uncertainty, and unpredictable supply chain and timelines. What if there were a way to simplify the journey—without compromising on quality, flexibility, or speed?
Join experts from Thermo Fisher Scientific for a customer-focused webinar that explores how a unified, global CDMO model can help biologic developers overcome the most pressing challenges in clinical and commercial manufacturing. With an integrated network of biologics capabilities spanning development through commercialization, Thermo Fisher Scientific enables greater continuity, reduced risk, and accelerated timelines—all tailored to your unique program needs.
In this session, we’ll discuss:
The real-world challenges faced by biologic developers today
How a single CDMO partner can streamline scale-up, tech transfer, and global manufacturing leveraging in-house experts and innovation
Case studies illustrating successful end-to-end partnerships
How Thermo Fisher’s global network delivers predictable outcomes and long-term value
An optimal Clinical Development Plan for Biosimilars
BiXAb MAIT engagers: redirecting an abundant cytotoxic T-cell subset to control solid tumors.
Developability and risk-based control strategies of antibodies and ADCs
Developability and risk-based control strategies of antibodies and ADCs
Discovery, development and manufacturing of optimized biologics using engineered CHO cells.
From In Vitro Discovery to Modular Protein-Protein-Conjugation: Combinatorial Assembly of Bispecific Antibodies
Promises and Challenges of Invio CAR - T therapies
Regulatory Harmonization for Biosimilars: Global Challenges and Opportunities
- The role of clinical studies in biosimilar approval.
- Variability in biosimilar regulations across different regions and its impact on development.
- Opportunities for regulatory alignment to streamline approval processes and global access.
- Addressing challenges in pharmacovigilance and post-approval requirements for biosimilars.
Stimulating collaborations across the ecosystem to advance the impact of cutting-edge patient treatments
- The importance of innovation ecosystems to advance research into real-world applications
- How to stimulate collaborations in deep tech for patient treatments
- Building strong and resilient innovation ecosystems
The Impact of Tissue Biopsy in Clinical Trials
Dr.DeboraSouza da Costa is a Principal Scientist with over 20 years of experience in biosample operations, biomarkers, genetics, and clinical trials. She holds a PhD in Pharmacology and currently leads biosample strategies for early-phase clinical development at Roche. Passionate about Personalized Medicine and patient advocacy, she is committed to translating science into meaningful benefits for patients.
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Treating Solid Tumors
Bridging Science and Policy: Regulatory Pathways for Biosimilars in Emerging Markets
- Explore the evolving regulatory frameworks for biosimilars in emerging markets, with a focus on harmonization and local adaptation.
- Highlight the scientific, technical, and policy challenges that shape regulatory decision-making.
- Share lessons learned and success stories from the Iraqi and MENA region experience to illustrate practical approaches to accelerating biosimilar access.
Clinical application of HLA peptidomics for precision immunotherapy
Prof. Dr. Tim Fugmann has studied technical Biology at the University of Stuttgart and later did his PhD at the ETH Zürich on"Innovative methodologies for the proteomic discovery of vascular markers in cancer and kidney disease". After the PhD he joined Philochem AG as head of target discovery with the aim to discover novel targets for pharmaceutical intervention. To better understand why certain patients respond to immunotherapy (which are developed by Philogen, the mother company of Philochem), his group implemented state-of-the-art HLA peptidomics technology for the study of T cell-cancer cell interactions. After nine years in industry, he moved to Berlin and joined the Max-Delbrück-Centrum for molecular medicine to work on bringing TCR T cell therapeutics from academic research into clinical trials. In February 2021 he was appointed to Professor for Proteomic with Focus on Mass Spectrometry at the JLU Giessen. The group worked with the state-of-the-art Orbitrap Fusion Eclipse mass spectrometer.
Cyto-Mine® Chroma: A multi-laser droplet microfluidics platform to accelerate clonal selection during therapeutic development
Sphere Bio’s Cyto-Mine® Chroma advances antibody discovery and cell line development with droplet microfluidics & multi-laser single-cell analysis. Leveraging picodroplet technology, it enables high-throughput screening of cells of interest, accurately sorting and dispensing single cells by productivity & viability, accelerating therapeutic development.
In this talk we will introduce Cyto-Mine® Chroma, highlight its multiplexing capabilities, present applications and assays for use with the platform, and have a look at the road ahead.
De-risking bispecific antibody development through early vector and expression system optimisation
Bispecific antibodies are a promising class of therapeutic proteins; however, their structural complexity can pose challenges in biomanufacturing, particularly in terms of expression titers and product quality. This presentation will explore the critical factors that influence early-stage development, with particular emphasis on expression system selection and vector optimisation. We will discuss the value of adopting a robust, scalable expression platform from the outset and, through a series of real world examples, we will demonstrate how the use of advanced vector technology, early design screening and optimisation can lead to increased titers without detriment to product quality. This proactive approach, when embedded within a broader de-risking framework, offers both scientific and strategic advantages, particularly for drug developers navigating the highly competitive bispecific antibody space.
Engineering Antibody-Cytokine Fusion Proteins (Immunocytokines) for Cancer Therapy
- Immunocytokines can increase the therapeutic index of the cytokine payload
- Immunocytokines can selectively localize at the tumor site
- Immunocytokines can induce potent anticancer activity either alone or in combination with other immunomodulatory drugs
Introducing a novel peptide linker technology for the direct modification of antibodies
STAb-T Immunotherapies: Novel Delivery Strategies for Bispecific T Cell Engagers in Cancer
The Specifica Generation 3 Antibody Library Platforms: High affinity drug-like antibodies and VHHs straight from in vitro selections.
Antibodies are vital therapeutics, but many fail due to poor developability traits, such as aggregation, poor stability and polyreactivity. The Specifica Generation 3 scFv Library Platform was designed to address this problem by embedding natural CDRs purged of sequence liabilities into highly developable clinical scaffolds, yielding highly diverse, high affinity (20% subnanomolar), developable (>80% lack biophysical liabilities), drug-like antibodies as potent or better than those from immune sources. This concept has now been extended to Fab and VHH libraries. This talk will discuss the in vitro selection of antibodies and VHHs from Specifica’s Generation3 library platform, as well as its application to affinity and developability improvement of antibodies generated from other platforms.
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Senior Representative, Nanotemper
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Senior Representative, Genovac Antibody Discovery
Cytokine-based precision therapeutics addressing todays unmet medical needs in infectious diseases, oncology and autoimmunity
Improving ADC development: high-throughput and in-depth characterization of ADCs by high-resolution mass spectrometry
Antibody-drug conjugates (ADCs) are targeted biopharmaceuticals that combine potent cytotoxic drugs with highly selective monoclonal antibodies to deliver chemotherapy specifically to cancer cells, reducing damage to healthy tissue and minimizing side effects. This allows for higher drug doses and increased efficacy. However, ADCs with lysine or cysteine conjugation sites are highly heterogeneous, making their characterization challenging. Determining conjugation sites accurately is key to effective targeting. The drug-to-antibody ratio (DAR) also impacts efficacy, safety, and therapeutic potential. High-resolution mass spectrometry is essential for characterizing ADCs, providing data on conjugation sites, molecular weight, stability, and impurities, and aiding in optimization and quality control.
In the present study, we have developed two analytical workflows for the characterization of ADCs:
1. High-Throughput SEC-MS Workflow: This approach operates under native conditions, enabling rapid analysis of drug load distribution and DAR via fully automated data processing.
2. High-Resolution RPLC-MS/MS Workflow: This method facilitates precise determination of conjugation sites, quantification of site occupancy, and analysis of other post-translational modifications.
In a forced degradation analysis, we demonstrated that exposure to elevated temperature stress significantly impairs both the DAR and the conjugation site, highlighting the vulnerability of ADCs under stress conditions. In addition to the detailed assessment of conjugation site occupancy, we were also able to identify and quantify several critical quality attributes (CQA) of the antibodies, including several deamidation and oxidation sites. These results provide valuable insights into the stability and integrity of ADCs and emphasize the importance of stringent quality control in the development process.
With our approach, we show that these analytical workflows are very well suited for both high-throughput and comprehensive characterization of lysine- and cysteine-conjugated ADCs and can be transferred to ADCs with other conjugation strategies. In general, this approach can be used in the development process of ADCs for the comparison of production batches, stability studies and forced degradation analyses for quality control and assurance.
Local Substrate and Response to Local Immunotherapy with InC01, Compartment-Locked IL-12
Maturation of MS Platform for Characterization of ADCs and Other Complex Biologics - Case Studies & Key Learnings
Repolarization and redirection of macrophages for tumor eradication
Robust bispecific antibodies through fusion of single-domain antibodies on IgG scaffolds
Therapeutic Antibodies: Rewiring Macrophages in the Tumor Microenvironment
As one of the most abundant immune cells in solid tumors, tumor-associated macrophages (TAMs) are characterized as high plasticity with both pro- and anti-tumor functions, depending on the microenvironment. On one hand, TAMs are capable of engulfing dying tumor cells, leading to the clearance of associated tumor antigens, which helps the tumor to escape the host immune surveillance. TAMs also secret immune-suppressive cytokines that maintain a pro-tumor microenvironment. Consequently, TAMs contribute to the resistance of checkpoint inhibitors, chemo/radio-therapeutic agents, and adoptive T cell immunotherapies in clinic. Alternatively, when TAMs are properly activated, they destroy live cancer cells or other immunosuppressive cells, acting as a defensive mechanism against tumors by killing them directly and indirectly. Thus, modulation of TAMs functions represents an attractive approach for cancer immunotherapy. Here, we share two case studies to exemplify that antibody drugs enhance cancer immunotherapy by modulating macrophage functions. First, we established a real-time, live cell imaging-based phagocytosis method that is fully automated with high throughput capability and less disturbance to macrophages. By using our established phagocytosis assay, we discovered potent anti-MerTK monoclonal antibodies (mAbs) that inhibit macrophage-mediated phagocytosis of apoptotic cancer cells both in vitro and in vivo. Dosing of anti-MerTK mAbs in a syngeneic mouse tumor model resulted in robust anti-tumor responses when combined with the checkpoint inhibitors anti-PD1/PD-L1. Leveraging our advanced imaged-based antibody-dependent cellular phagocytosis (ADCP) assay, we discovered a novel mAb with enhanced ADCP mediated by macrophages. This mAb uniquely targets and efficiently depletes tumor-infiltrating regulatory T (Treg) cells, a critical population of immune-suppressive cells in the tumor microenvironment. This constitutes another promising strategy for targeting the immunosuppressive tumor microenvironment. Besides drug discovery, our established imaged-based phagocytosis methods have broad applicability to dissect the kinetics and molecular mechanisms of cellular phagocytosis.
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Accelerating IND timelines for next-generation biologics: strategic CMC approaches and the power of DoE
The biopharmaceutical landscape is rapidly evolving, with an increasing number of novel protein formats advancing toward clinical trials. These newer modalities present unique CMC challenges that demand tailored, agile and data-driven approaches. Strategic partnerships with experienced CDMOs are key maintaining speed and quality in this dynamic environment.
This presentation showcases Lonza's integrated DNA-to-IND and DNA-to-tox programs, designed to streamline and de-risk biologics development. Through real-world case studies, we will explore how leveraging Design of Experiments (DoE) across the development cycle enables faster data-driven decisions, robust process design, and deeper product understanding.
By leveraging decades of expertise and cutting-edge technologies, Lonza can unlock new opportunities for innovators to confidently advance their next-generation biologics to the clinic and, ultimately, to patients.
Clinical Data Management in Rare Diseases
Development and Dissemination of affordable cell based immunotherapies for low income countries
Dr. Marco Traub is a Neuroscientist who gained considerable experience in a number of stem cell expert and management and educational roles over the past 20 years. He acts as CEO of the Trans European Stem Cell Therapy Consortium (TESCT) and as an EU-Commission expert in FP7 and the Innovative Medicine Initiative (IMI JU) 2018, which is a public private partnership between the European Commission (FP6/FP7/ Horizon 2020, Health and Life sciences) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) and COST framework for Switzerland.
While in Switzerland and UK, he specialised in Biotechnology, with a focus on PCR technology and peptide synthesis and their GMP production. In the same period he was Assistant Professor at the Medical School at the University of Kansas City. There he was involved in research projects and teaching neuro-anatomy and opiate receptor pharmacology as well as in molecular medicine.
Development and Dissemination of affordable cell based immunotherapies for low income countries and hospitals
Developments at Phenomic
Human Antibody Discovery and Engineering: The Adimab Way
This presentation will explore how Adimab has revolutionized therapeutic antibody discovery, growing from an innovative startup into a leading platform technology company. We will examine key technological breakthroughs in our platform development, focusing on synthetic antibody library evolution, advances in multispecific antibody generation, and novel approaches to antibody developability optimization. Through specific examples, we will demonstrate how our engineering solutions have enhanced therapeutic candidates and improved their potential for success. Join us to learn how Adimab's systematic, engineering-driven approach is shaping the future of antibody therapeutics.
Leveraging the integrated ATUM platform for improved manufacturability of next-generation biologics
ATUM leverages its integrated gene design, synthesis, protein engineering, and cell line development platforms to accelerate the discovery, optimization, and manufacturing of bispecific antibodies. The platform enables rapid prototyping and functional screening of diverse bispecific formats. This talk will highlight case studies demonstrating how ATUM’s platform facilitates the efficient development of bispecific antibodies.
Panel Discussion How the EU medicine regulatory network can support ATMP developers
ATMP development still faces several regulatory hurdles, particularly for academic groups and smaller companies. Here, we discuss these challenges and how regulators can support innovators.
The Tubutecan Platform – Technology Enabled Payload Solutions Targeting Topoisomerase-I: Preclinical Data for Solid Tumor Targeting ADC Candidates TUB-030 and TUB-040
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Turning Cold Tumors Hot: Targeted TNF Potentiates the Activity of Bispecific T Cell Engagers in Solid Tumors
Cold tumors remain largely unresponsive to T cell engagers (TCEs) due to the immunosuppressive tumor microenvironment and poor T cell infiltration. Here, we show that targeted TNF delivery potentiates CD3-based TCE activity, leading to robust tumor eradicationin vivo. Cured mice resisted tumor rechallenge, demonstrating long-term protective immunity. Mechanistically, TNF remodeled the tumor microenvironment, promoting sustained T cell infiltration and durable antitumor memory.
A next generation ADC for Nectin-4 expressing tumors: preclinical characterization of IPH45, a novel and differentiated exatecan-based ADC targeting Nectin-4
ANV700: A Proximity-Activated IL-21 Therapeutic Targeting PD-1+ Tumor Infiltrating Lymphocytes
- Targeted IL-21 delivery:ANV700 is a Proximity-Activated Cytokine (PAC) that selectively delivers IL-21 to PD-1+ tumor-antigen specific T cells, maintaining strong IL-21 signaling in PD-1+ cells while minimizing off-target activation and systemic toxicity.
- Enhanced Tumor-Specific CD8 T Cell Activity: In mouse tumor models, ANV700 surrogate compound treatment leads to tumor growth retardation by increasing the number and functionality of tumor antigen-specific CD8 T cells.
- Synergistic Therapeutic Potential:ANV700 synergizes with PD-1 checkpoint inhibitors and PD-1-targeted IL-2Rβγ agonists, combining proliferative and reinvigorating effects for a durable anti-tumor response, supporting its development as a monotherapy or combination therapy.
BEAT®: A Platform to Advance Multi-specific Therapeutic Antibodies to the Clinic
Development and clinical readiness of novel armoured Adaptor CAR T-cells for the treatment of solid tumours
NKG2D ligands are an attractive target for CAR T cell immunotherapy
CARs comprising the co-expression of an NKG2D receptor and a DAP10/DAP12 fusion protein performs significantly better than a matched linear CAR incorporatingCD3z
Armouring of CAR T cells with CXCR2 results in a significant increase in the efficiency of CAR T cell trafficking to the tumour site
Sane in the membrane - Discovery of antibodies against challenging membrane protein targets using Salipro nanoparticles
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Precision controlled biomanufacturing using off the shelf, ready-to-use components: from bench to clinic
Precision-controlled biomanufacturing, cell processing tools, and particle separation technologies are pivotal in the production of Advanced Therapy Medicinal Products (ATMPs), synthetically cultured biologics, and laboratory-grown food. As the demand for efficient, consistent, high-performance, and scalable manufacturing solutions intensifies, adaptable downstream cell processing platforms have become essential. Single-use systems offer a promising solution by providing operational simplification, reduced cross-contamination risks, flexibility, and minimal downtime. Nevertheless, the validation of these systems remains a critical concern, necessitating assurance of consistent performance, material compatibility, integrity, sterility, and regulatory compliance.
This session will present data from the development of a ready-to-use, sterile plug-and-play assembly designed to streamline critical processes such as cryo-preservation, cell banking, mammalian cell growth, separation, filling, and storage applications. We will also explore key validation considerations for single-use systems, highlighting the challenges and risks associated with transitioning from traditional aseptic technologies to innovative alternatives like the featured plug-and-play assembly.
Attendees will gain valuable insights into cutting-edge systems utilized across the life sciences and the meticulous steps required for their successful validation
Vytal®: The ready-to-use snap-fit system for container closure solutions, setting the standard for the future.
In recent decades, the landscape of parenteral drug production has undergone significant transformation, driven by the emergence of novel molecules and advanced therapies. The pharmaceutical industry has witnessed a notable shift towards biologics, mAbs, and cell-based therapies, which now represent some of the most successful pharmaceutical products globally.
The production of biotherapeutics presents unique challenges due to their inherent instability and specific containment requirements. This has necessitated a fundamental reimagining of manufacturing processes, with aseptic filling becoming essential in modern pharmaceutical production.
Vytal®, an innovative RTU snap-fit closure is specifically designed for small to medium-batch production of advanced therapeutics, including biologics, viral vectors, mRNA, antibody-drug conjugates, cell & gene therapies and orphan drugs.
Developed under ISO13485 and GMP Annex I requirements, Vytal® offers:
· Snap-fit system
· Ready-to-use
· Glass & COP vial compatibility
· CCI assured even at low temperature (-80 °C)
· Compatibility with standard marketed CSTDs
· ISO dimensions
· Nested & Bulk
· Full visibility
· Reduced particle generation
· Low residual volume
· Anti-counterfeiting: Tamper-evident features & laser marking
Vytal® helps pharmaceutical companies accelerate time-to-market while maintaining high-quality standards, meeting the demands of modern filling technologies and competitive market pressures.
A next generation ADC for Nectin-4 expressing tumors: preclinical characterization of IPH45, a novel and differentiated exatecan-based ADC targeting Nectin-4
Benefit risk framework for regulatory decision next steps
Beyond the Protocol: Key Steps for a Successful and Timely First Clinical Trial
- Quality Management System: Implement robust processes to ensure consistency and compliance
- Clear Project Management: Align timelines and budget from planning through execution
- Strategic Framework: Define trial objectives, resources, and collaboration essentials for success
Developing curative gene therapy for a severe immune deficiency
Engineering human cytokines for therapy
Engineering of bispecific antibody-based IL-12 mimetics with biased agonism capacities
Engineering of bispecific antibody-based IL-12 mimetics with biased agonism capacities
Harnessing IgA for Cancer Therapy: A Local Production Approach with Tumor-On-Chip and In Vivo Validation
Streamlining M-gager Development: From CHO Pool to Process Lock
CDR-Life is transforming the treatment of cancer and autoimmune diseases with its proprietary M-gager® T cell engager format, enabling highly selective targeting of both conventional and previously difficult-to-addressantigens. Our integrated, end-to-end development approach accelerates the creation of promising drugs against challenging targets. This is achieved through synergistic, multidisciplinary collaboration across the discovery, pharmacology, preclinical, and technical development functions at CDR-Life. To streamline process development toward clinical manufacturing, our CMC team leverages a strong partnershipwith a cell line developer for synchronized CHO cell line and upstream process development. Our established M-gager® platform process facilitates efficient process development starting with stable pools, enabling the production of representative material for animal and preclinical safety studies at an early stage. We reduce risks and ensure smooth, timely tech transfers by aligning clone selection and process optimization with both the cell line provider and the CDMO. Our integrated approach supports rapid development and scalable manufacturing, positioning CDR-Life to deliver transformative immunotherapies to patients with high unmet needs
The Therapeutic Potential of IgE and IgE-derived Antibodies
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Senior Representative, Lightcast
Antibody-Cytokine Fusions for Cancer Therapy: Late-Stage Clinical Results
- Cytokines are modulators of the immune system that can be used for cancer therapy
- Cytokines can be anchored to the TME by means of antibody delivery
- Combinations of tumor-targeted cytokines can elicit a potent, synergistic anti-cancer activity
Bifunctional antibody derivatives for immune system manipulation
- Generation and characterization of single-domain antibody derived bispecifics
- Mimicking the function of a cytokine by triggering agonism on its receptor
- Antibody engineering to further improve the agonism
Bifunctional antibody derivatives for immune system manipulation
Disrupting Peptide Therapeutics: Numaferm’s Numaswitch Platform for Sustainable, Scalable, and Scarless GLP-1 Analog Manufacturing
The demand for high-purity, scalable, and cost-effective production of GLP-1 receptor agonists and related peptide therapeutics continues to rise—yet traditional synthesis approaches remain constrained by sustainability, scalability, and cost limitations. Christian Schwarz, PhD, Founder and CSO of Numaferm GmbH, introduces a new paradigm in peptein manufacturing with theNumaswitch platform: a fully biotechnological production system enabling thetraceless, efficient, and sustainable manufacture of native peptides and proteins.
At the core of this platform isNumacut, a proprietary protease engineered to cleave after nearly all amino acids (except proline), enabling scarless removal of fusion tags and overcoming a longstanding limitation of conventional sequence-specific proteases like TEV. In tandem with Numaferm’sSwitchtag technology, this platform allows seamless integration ofnon-canonical amino acids, high-purity expression, and simplified downstream processing.
Numaswitch offersproduction timelines of less than 2 weeks,scalability to 100 kg per campaign, and isfree from toxic solvents, TFA, and non-sustainable reagents. Compared to traditional chemical synthesis, it deliversCO₂ footprint savings exceeding 90%andcost-of-goods reductions of over 85%, meeting increasing regulatory and environmental expectations.
These capabilities make Numaswitch a compelling solution for next-generation GLP-1 analogs, where molecular complexity, sustainability, and time-to-market are critical. Real-world applications will be discussed, highlighting how Numaferm's innovations translate intosecure supply chains,lower environmental impact, andtransformative economicsfor advanced peptide-based therapeutics.
Navigating regulatory success for Biologics: why early establishment of a Quality System is essential
Sustainability in Clinical Operations
TCR-Specific Engagers that Selectively Target IL-2 to Tumor-Specific T Cells
The Path to Enlightenment: Strategic Photostability Testing & Light Mapping in Fill & Finish Operations
- Photostability Studies in CMC Development: Strategic implementation of forced degradation and confirmatory photostability testing at critical development milestones to identify light-sensitive products and establish appropriate protection requirements.
- Comprehensive Light Mapping Methodology: Systematic approach to quantify light exposure across fill and finish operations, focusing on critical processing areas where product is most vulnerable to photodegradation.
- Risk Mitigation Strategies: Development of effective light protection measures based on photostability data and light mapping results, including facility modifications, process adjustments, and monitoring protocols.
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Senior Representative, BSP Pharmaceuticals
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Senior Representative, GenScript
Bridging Clinical Operations and GMP Requirements: A Strategic Imperative for Emerging
Clinical operations are a cornerstone of health product development, yet their success relies on seamless alignment with Good Manufacturing Practice (GMP) requirements—particularly in the management of investigational medicinal products and subcontracted activities. This interface, often underestimated, becomes a pressure point for sponsors lacking in-house pharmaceutical resources How can regulatory and GMP constraints be anticipated as early as the clinical planning phase? What are the best strategies to ensure batch certification, qualification of manufacturing partners, or implementation of an efficient quality management system in the absence of in-house resources? This dual perspective—clinical and pharmaceutical—demonstrates how the early integration of GMP requirements into clinical operations is a key success factor, ensuring regulatory compliance, operational efficiency, and credibility with health authorities.
Designing for Complexity: Workflow Solutions for Multifunctional Biologics
The biopharmaceutical industry is shifting from traditional monoclonal antibodies to multi-specific and structurally complex biologics to address increasingly personalized diseases. These formats pose challenges in expression, stability, and manufacturability, requiring advanced development platforms.
To address these demands, we’ve developed an integrated strategy using a proprietary CHO cell line engineered with over 100 dock sites across the genome. This design allows us to precisely control expression through copy number with universal vectors, enabling rapid screening of expression profiles and the generation of high-titer pools under 30 days. Complementing this is a high-throughput process development workflow that can be rapidly tailored to the unique requirements of complex molecules. This platform facilitates efficient optimization of both upstream and downstream parameters, ensuring stable, high-yield expression across a wide range of protein formats.
Together, these technologies provide a robust and scalable foundation for the development of next-generation biologics, delivering improved product quality and accelerated timelines. This integrated approach enables the reliable advancement of complex therapeutic candidates from early development through to clinical and commercial readiness.
Directed Luck®: Transposase targeting and Transposon design push expression beyond limits
Transposases have eased cell line development. Taking this concept to a new level, we equipped our hyperactive transposase with epigenetic readers that targets highly active genomic sites in the host cell line and designed advanced transposons with optimized ITRs for most efficient and clean integration. DirectedLuck® delivers highly productive clones and bulk pools ready for manufacturing and is particularly suited for heterodimeric formats, polyclonal antibody cell lines and viral vector packaging cell lines.
Leveraging a toolbox approach to enhance cell line development for multi-specific molecules
In recent years, the emergence of more complex biologics has been driven by the need to address diverse disease indications. These novel molecule formats including multi- and bispecific antibody formats, present challenges for standardized cell line development platforms. To overcome these challenges, both innovative technologies and highly customizable strategies are essential for creating optimal cell lines for manufacturing. At Sartorius, we have adopted a toolbox approach and combined it with automation and predictive modeling to achieve optimal titer and product quality profile. In this talk, we will expand on how this highly adaptable framework enables us to develop optimal cell lines for multi- and bispecifics and push the boundaries of non-standard antibody formats.
Maximizing MSC-EV Yield with Preserved Quality Using a Xeno-Free, Defined Formulation
DrTarikHadi has recently joined Takara Bio Europe as a Senior Market Strategy Manager focused on Cell & Gene Therapy.
Prior to joining Takara, Dr Hadi worked as a postdoctoral researcher at the New York University Langone Medical Center, where he uncovered crosstalks between immune and vascular cells during the development of abdominal aortic aneurysms.
Dr Hadi obtained his PhD in Molecular Biology at the University of Burgundy, France in 2013; During his thesis, he contributed to identify regulatory mechanisms of inflammation leading to the onset of preterm labor.
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Trispecific eFab-eIg T-cell Engagers Using the eIg Technology
- We present a novel approach to generate trispecific antibodies based on the previously developed eIg technology comprising one Fab and two eFab moieties that were fused to obtain an asymmetric eFab-eIg molecule
- The trispecific TCE retained binding activity for all three antigens (HER2, HER3 and CD3) and was capable of recruiting T-cells to HER2 and/or HER3-expressing cancer cells and mediating effective cancer cell killing, as shown in 2D and 3D model systems
- Due to the modulararchitecture, this approach should be suitable to generate trispecific antibodies of any specificity and for a multitude of applications
Unveiling the PanCancer potential of dual-mechanistic uPAR-targeting ADCs across cancers
Currently, most approved antibody-drug conjugates (ADCs) target tumor-associated antigens. However, this approach hinders effective treatment of solid tumors, particularly those with a dense stromal microenvironment, like pancreatic cancer (PDAC), where the tumor stroma contributes to disease progression, immunosuppression, and drug resistance. To address this challenge, we have developed PanTarg, a novel ADC designed to target both cancer cells and the surrounding stromal environment. PanTarg specifically targets the urokinase plasminogen activator receptor (uPAR), which is overexpressed in both the tumor and stromal compartments of many aggressive cancers, particularly PDAC, with limited expression in normal tissues. This dual-target strategy aims to overcome stromal barriers and expand the range of indications and patient populations that can benefit from ADCs. PanTarg is based on a proprietary uPAR antibody with optimal ADC properties. In preclinical models of PDAC and other uPAR-positive tumors, PanTarg has demonstrated strong anti-tumor and stromal effects, bystander and immune modulatory activities, and good tolerability. These promising results validate uPAR as a compelling ADC target and position PanTarg as a potential new therapeutic option, either as a monotherapy or in combination therapies.
Amanitin-based ADCs Overcome Resistance in Cancer Patients
Developability and manufacturability considerations for next-generation biologics
Next-generation antibodies, including bispecifics and multispecifics, offer unique therapeutic applications in various human diseases. However, in order to do so, their deviations from traditional monoclonal antibody structures also present developability and manufacturability challenges. We will discuss our latest work on the developability assessment, such as the polyreactivity and aggregation propensity properties of various next-generation biologic candidates, in the overall aim of driving their rational development and optimization towards therapeutic success.
Developing Avidity-driven Tumour Selective Multispecific Antibodies
Development of remotely controlled armoured CAR T cells
Enhancing Cancer Immunotherapy by Targeting Cancer-Associated Glycans
- Immune checkpoint inhibitors have led to long-term remission in some cancer patients, but the majority still do not benefit from current immunotherapies.
- Targeting cancer-associated glycans—via glycan-specific antibodies, CARs, and bispecific antibodies—offers a promising strategy to overcome resistance to current treatments.
- Modifying the tumor microenvironment through glycan-engineering using enzymes or small molecules has shown enhanced efficacy in preclinical models, with early clinical trials now underway.
NANOBODY® VHH as a modality for Targeted Protein Degradation
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Towards Advancing the Biosimilar’s development pathway (The future of phase III)
Accelerate antibody variant screening and development
Biotherapeutics is the fastest growing sector in the pharmaceutical industry.While the market is still largely dominated by monoclonal antibodies (mAbs), a growing number of non-traditional antibody formats are driving increased molecular diversity. These new formats offer advantages like dual targeting, better tissue penetration, and the ability to cross the blood-brain barrier. However, their structural complexity introduces new challenges in purification, analytics, and manufacturing. Traditional mAb purification relies on platform methods using affinity resins like Protein A. For novel antibody formats, customized solutions are needed, and in this presentation, we will introduce new chromatography resins like MabSelect™ VH3 and MabSelect™ Mild Elution, designed to meet these evolving needs. As the biologics pipeline expands, the demand for robust, high-resolution analytics grows. Biacore™ systems provide detailed insights into titer, potency, binding kinetics, and epitope specificity across a wide range of molecule types. In this presentation we will show how selecting antibodies based on developability, efficacy, and safety is key to successful CMC progression. Case studies will include epitope binning, clone selection, bispecificity assessment, and thermal stability testing under physiological conditions. We will close by briefly mentioning PrismA ELISA™ kit, specifically designed for detecting residual PrismA protein A ligand from chromatography resins.
Advancing Therapeutic Oligonucleotide Manufacturing: Oligo Factory’s GMP Solutions for Clinical Success
The increasing demand for high-quality oligonucleotides in therapeutic applications necessitates scalable, efficient, and compliant manufacturing processes. Oligo Factory is at the forefront of this demand, offering ICH Q7 GMP-compliant oligonucleotide manufacturing with a focus on therapeutic oligonucleotides such as ASOs, siRNA, aptamers, and guide RNAs. This presentation will highlight Oligo Factory’s proprietary synthesis platform, scalable production capabilities, and comprehensive analytical services designed to meet rigorous regulatory standards.
Attendees will gain insights into how our U.S.-based and sourced GMP facility streamlines oligonucleotide manufacturing, ensuring the highest quality, rapid turnaround times, and flexible support from late discovery through clinical phases. In addition, we will explain our key process optimizations that enhance efficiency and consistency, enabling the reliable production of complex oligonucleotides for therapeutic development. Join us to explore how Oligo Factory is advancing the next generation of oligonucleotide-based therapies.
Clinical Development Workshop
·Vaccines Clinical Development and why a Education in this field is needed
·Impact of Vaccines on Antimicrobial resistance
·Use of Modelling in Vaccines Clinical Development ( a recently published use case)
Operational Excellence in Drug Development and Supply Chain Management
- Operational Excellence in Drug Discovery Supply Chain Management" is structured to provide a comprehensive overview of how operational excellence drives efficient, resilient, and high-quality processes across the pharmaceutical value chain—from drug discovery to commercialization. The discussion opens with a focus on Operational Excellence (OpEx) in the context of drug discovery, development, and commercialization, emphasizing its pivotal role in enhancing quality, productivity, and innovation throughout the product lifecycle.
- Real-world case studies, such as the supply chain maps for Fasenra and Imfinzi, will illustrate the practical application of OpEx principles in managing the complex logistics and regulatory requirements of life sciences products. The summary then explores the core principles underpinning operational excellence, including continuous improvement, process standardization, and value creation, as well as the importance of robust business process management.
- A detailed review of the tools and techniques used to achieve operational excellence will be provided, encompassing methodologies such as Lean, Six Sigma, and digital enablement. This will be supported by further examples highlighting successful operations and supply chain initiatives, demonstrating how OpEx concepts translate into measurable performance improvements. The agenda also addresses how to navigate volatile, uncertain, complex, and ambiguous (VUCA) environments, reflecting on the need for agility and adaptability in current global supply chains. Finally, the role of people and culture in underpinning operational excellence will be considered, highlighting the importance of leadership, cross-functional collaboration, and a continuous improvement mindset.
Roundtables
AAV as a Vector for Gene Therapy Delivery
Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, and Fc fusion proteins
Automation and AI in Mass Spectrometry Workflows: Hype or Hope?
Dry State, High Stakes: Formulating the Future of Biologics
Form Meets Function: Aligning Therapeutic Designs with Biological Mechanisms
Generative AI for Protein Design General Inception - A venture capital firm that partners with innovators to nurture groundbreaking ideas across the biotechnology sector
Identifying and resolving pain points in biomanufacturing
ML for engineering multi-specific antibodies
Recent Trends for Immune-Cell Engagers: TCR-mimic antibodies.
Targeting the CNS
Advancing Peptide Therapeutics: Cell-Based Potency Assays for GLP-1, GLP-2, and GIP Receptor Agonists
Peptide-based drugs represent a cornerstone of modern therapeutics, particularly in the treatment of metabolic disorders. In the evolving landscape of obesity research, GLP-1, GLP-2, and GIP receptors have emerged as key targets for next-generation therapies. Reaction Biology supports this innovation by offering custom research-grade peptide synthesis and robust cell-based potency assays tailored to these receptor systems.
Our assay platform utilizes an indirect cAMP readout to quantify receptor activation, enabling precise IC₅₀ determination for each receptor independently. This approach supports both early-stage drug development and batch release testing. We demonstrate the platform’s capabilities through in-house synthesis of Semaglutide, development of a GLP-1 assay using Saxenda as a model agonist, and comparative analysis of marketed reference compounds including Liraglutide, Tirzepatide, and Teduglutide.
By enabling receptor-specific potency profiling and supporting single- or dual-receptor targeting strategies, our assay system provides a powerful tool for advancing peptide drug discovery. Importantly, these assays can also be performed under GMP conditions for batch release testing.
Biosimilars in Denmark: Easy market access, high uptake, increased patient care and sustainable health care budgets.
Building trust through Pharmacovigilance, Compliance, and Quality
Driving Biologics Innovation: A New Innovation Ecosystem for High-Impact Discovery at Roche pRED
Driving Biologics Innovation: A New Innovation Ecosystem for High-Impact Discovery at Roche pRED
Sustaining a leadership position in biologic therapeutics requires a forward-thinking approach to research and development. At pRED we undertook a mission to build a more efficient and data-driven innovation engine. The goal was to move beyond traditional innovation management towards a system that actively identifies and manages high-impact opportunities to advance our drug discovery portfolio. We implemented a novel framework that combines traditional portfolio management approaches with collaborative intelligence with advanced, LLM-based proposal reviewing. This system enables us to transparently evaluate new technologies, identify synergies across projects, and pinpoint solutions for critical gaps in our discovery pipeline. This presentation details our journey in building a robust innovation engine, outlining the different tools and strategies developed to optimize R&D productivity and expand our target space.
Engineered IL-2/antibody fusion proteins confer autoimmune disease protection through selective expansion of specific immune cell populations
- Progress in cytokine engineering is driving therapeutic translation by overcoming the limitations of these proteins as drugs
- We designed intramolecularly assembled single-agent fusion proteins (immunocytokines, ICs) which comprise of IL-2 linked to various biasing anti–IL-2 antibody that direct the cytokine towards regulatory immune cells, leading to superior autoimmune disease protection
- F5111 IC, which potently and selectively activates and expands regulatory T cells, conferring disease protection in mouse
- models of ulcerative colitis and immune checkpoint inhibitor-induced diabetes mellitus
Enhancing Antitumor Responses through Combined Checkpoint Inhibition
- Review of key checkpoint inhibitors and their individual mechanisms of action
- Preclinical and clinical evidence supporting the synergistic effects of combination strategies
- Perspectives on future directions, safety considerations, and patient selection for combination therapy
Expanding the use of monoclonals antibodies into cellular immunotherapy
Expediting Online Liquid Chromatography for Real-Time Monitoring in Downstream Processing of Biopharmaceuticals
The application of Process Analytical Technology (PAT) principles for manufacturing of biotherapeutics proffers the prospect of ensuring consistent product quality along with increased productivity as well as substantial cost and time savings. Although this paradigm shift from a traditional, rather rigid manufacturing model to a more scientific, risk-based approach has been advocated by health authorities for almost two decades, the practical implementation of PAT in the biopharmaceutical industry is still limited by the lack of fit-for-purpose analytical methods. In this regard, most of the proposed spectroscopic techniques are sufficiently fast but exhibit deficiencies in terms of selectivity and sensitivity, while well-established offline methods, such as (ultra-)high-performance liquid chromatography, are generally considered as too slow for this task. To address these reservations, we introduce here a novel online Liquid Chromatography (LC) setup that was specifically designed to enable real-time monitoring of critical product quality attributes during time-sensitive purification operations in downstream processing. Furthermore, we will highlight the expansive opportunities of online LC based applications to serve as a PAT tool for biopharmaceutical manufacturing.
Generative AI for Protein Design
Insights into the future of Gene Therapy
Prediction of antibody developability properties at scale
- We developed machine learning models to efficiently predict key antibody developability properties.
- Predictions can be scaled up to process large numbers of antibodies.
- Our models can be used in a multi-objective optimisation setting.
Selective Human Receptor Modulating Peptides for GPCR agonism and antagonism
Advances in Structure-Based Computational Modeling and Collaborative Enterprise Informatics for Biologics
Optimizing biologic drug candidates to enhance favorable traits or minimize liabilities often demands significant experimental effort. This presentation will showcase recent progress in our physics-based, structure-guided computational methods that help accelerate the optimization process. It will cover key challenges in antibody engineering—including predicting antibody-antigen binding affinity, improving structural stability, and addressing developability concerns. The talk will also illustrate how these approaches can be integrated within a collaborative informatics platform for biologics discovery, which can merge machine learning (ML) results, experimental data and advanced modeling, execution, and analysis tools to streamline decision-making and centralize essential project information.
Challenges of Viral Clearance in a Downstream AAV Process and future directions
Cutting Through the Hype: Real-World Applications of AI in Antibody Discovery and Engineering
Senior Representative, Ailux
Enara’s Dark Antigen Platform for immunotherapies
Improved Antibody Discovery using High-Density Antigen Display with Engineered Virus-Like Particles
Senior Representative, Icosagen
Myeloid checkpoint blockade in combination with IgA antibodies
- IgA antibodies improve myeloid effector cell recruitment
- myeloid checkpoint blockade to enhance antibody efficacy
- novel approaches to interfere with sialic acid/Siglec interactions
Patient and Public Involvement in clinical studies. The importance of the contribution of a Patient Advisory Board
Phage Display: Current Trends and Future Directions
- Evolution of Phage Display Libraries: From early, non-rational designs to third-generation libraries enhanced by next-generation sequencing (NGS) and synthetic biology. Emerging approaches focus on data-driven design, predictive modeling, and AI to expand diversity, minimize sequence liabilities, and improve biophysical properties.
- Advancements in Panning Strategies: Modern selection strategies integrate NGS monitoring and AI support to identify diverse, antigen-specific binders. Rational and developability-oriented process design, combined with AI-guided sequence optimization, helps reduce the occurrence of sequence liabilities and negative hits.
- Integration with Advanced Technologies: Hybrid platforms incorporating microfluidics, biosensor-based rapid selection, and single-cell technologies could enable precise, high-throughput biopanning control and facilitate the screening of complex libraries.
Revisiting Biomarkers in Lupus Nephritis
Affinity by Design – Building Scientific Software Inspired by Natural Antibody Evolution
Antibody engineering to maximize clearance of abundant targets Development of an anti-IgA degrading antibody
Artificial intelligence methods to detect dengue-specific antibody repertoire and sequence patterns
Ensuring Fast & Reliable Antibody Drug Development for Autoimmune Diseases
Autoimmune disease is a collection of multiple severe clinical conditions that affect 3-5% of the total population worldwide, involving disrupted immune cell activation and escalated inflammation in the patients. Amongst other biologics, therapeutic antibodies are a leading and increasingly widely applied approach. With the rapid exploration of new targets and signaling pathways, numerous targets remain to be discovered and optimized. In this talk, we present various case studies, technologies, and analytical methods designed to ensure a ‘native’ protein that is structurally and conformationally accurate, maximizing bioactivity and assisting in the discovery of new targets for autoimmune diseases.
In vivo application of the TFAMoplex, a protein-based DNA transfection agent
Patient input into study design and conduct
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Unlocking Precision: The Versatility of Athebody Platform for targeted Therapeutics
Unlocking the Potential of Human-derived Antibodies for the Treatment of Allergies, Neurological and Inflammatory Disorders
Clinical Trial Design and Regulatory Considerations for Hematological Gene Therapies
CUE-401: A Novel IL-2/TGF-beta Fusion Protein for the Induction & Expansion of FOXP3+ Regulatory T Cells
From Code to Cure with Unigen AI/ML Platform: Compugen Advance the Next Generation of Cancer Immunotherapies
In Silico Immunogenicity Risk Assessments: AI- Enhanced Prediction of Clinical Immunogenicity Outcomes with EpiVax’s ISPRI Toolkit
The development of biologic therapeutics necessitates comprehensive strategies to assess immunogenicity, a key factor influencing drug efficacy and safety. This presentation will focus on the innovative use of in silico immunogenicity risk assessment tools, particularly the AI-enhanced ISPRI (Interactive Screening and Protein Reengineering Interface) toolkit from EpiVax. ISPRI’s computational methods identify effector and regulatory T cell epitopes and predict anti-drug antibody (ADA) responses, offering insights into minimizing risks during the drug development process.
As biologic formats increase in complexity, assessing the immunogenic potential of various constructs becomes critical. The adaptation of established immunogenicity analysis approaches to evaluate CD4+ T cell epitope content in multifaceted biologic formats, including non-antibody scaffolds and bispecific antibodies, will be discussed. This adaptation offers valuable insights into the distinct characteristics of individual components that may influence immunogenic responses. In a retrospective analysis of monoclonal and bispecific antibodies, ISPRI predictions provided consistent results in a fraction of the time and cost compared to published immunogenicity risk assessments made by combining observations from three in vitro assays and public in silico tools. In addition, nearly all (92%) promiscuous T cell epitopes predicted by ISPRI aligned with peptides identified in MHC-Associated Peptide Proteomics (MAPPS) assays, considerably outperforming traditional public T cell epitope prediction tools.
AI and machine learning (ML) have recently been integrated into ISPRI, significantly enhancing its predictive accuracy by a six-fold increase in the correlation between predicted and observed ADA rates, as well as an 85% reduction in false negatives. The integration of AI into in silico immunogenicity assessments represents a significant leap forward in the biopharmaceutical development landscape. By enhancing the predictive capabilities of existing tools like ISPRI, researchers can make informed decisions early in drug development, ultimately leading to safer and more effective therapeutic options.
IOMX-0675 - A Differentiated and Highly Potent LILRB1 and LILRB2 Targeting Antibody
- LILRB1 and LILRB2 play an important role in modulating the immunosuppressive tumor microenvironment in solid tumors while LILRA1 and LILRA3 are closely related immune-activating family members
- We applied our proprietary phage display library to select IOMX-0675, a fully human antibody, clearly differentiating between LILRB1/2 and LILRA1/3
- The unique binding profile translates into high efficacy positioning IOMX-0675 as a dual-targeting checkpoint inhibitor with best-in-class potential.
- Recent CTA approval enables preparing for a FIH study
New Born Screening
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Senior Representative, Kactus
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Unlocking Europe’s Biotherapeutic Potential: Biosimilar Policy That Works for Patients and Industry
- The Biotech Act & Competitiveness Compass: Reframing Biosimilar medicines as Strategic Assets
- CompetitionBeyond Price: A New Access Paradigm in Pharma Legislation Reform
- Closing the Biosimilar Void: Converting Potential into Uptake and Access
A Brief History of Biosimilars Development,...an Unfinished Symphony
A machine learning-driven approach for the multi-parametric optimisation of T-cell engagers
T-cell engagers (TCEs) promise breakthroughs in the treatment of solid tumors, but their progression in the clinic is limited by on-target, off-tumor toxicity. In this talk, I describe how our platform integrates active learning, automation, and high-throughput functional assays to efficiently identify highly selective and potent TCEs. I highlight our utilization of the design-build-test-learn ecosystem to generate high-quality data that powers our machine learning models and therapeutic assets.
Circular DNA, Circular Economy: Redefining Critical Quality Attributes for Sustainable Plasmid DNA Manufacturing
Computational Protein Stabilisation: What Works, What Doesn’t, and Why
- I present a structured overview of computational methods currently available for protein stabilization.
- Drawing on both published literature and our internal efforts, I evaluate the relative effectiveness of these tools.
- I propose potential factors underlying the different success rates of these methods in stabilizing proteins.
Light On – Tumor Off: How Quencher - Fluorophore Technologies Improve ADC Designs
- Mechanism of Action: Understanding how ADCs deliver cytotoxic drugs directly to cancer cells.
- TORCH Technology: A groundbreaking tool for tracking internalization and release kinetics.
- Insightson target receptor expressions and ADC potencies.
New opportunities to overcome the efficacy and toxicity problems of immunotherapies with affinity-switchable antibodies
The importance of Patient Centricity
Accelerating Breakthrough Innovations in Healthcare
- The Johnson & Johnson external innovation team is interested in collaborating with entrepreneurs at startup companies, universities and institutes who are developing early-stage innovations that are pre-proof of concept in humans across the Innovative Medicine and MedTech business segments
- Our JLABS incubators offer the largest global network of open innovation ecosystems that enables and empowers emerging companies with knowledge, experience, partnerships, and venture connections across a broad healthcare spectrum
- JJDC is Johnson & Johnson's corporate venture capital (CVC) organization. With more than 50 years of experience, we are the longest-running healthcare CVC in the world. We invest in medtech and biotech innovation across all stages of translation
Clinical and Molecular Characterisation of Primary Refractoriness to Atezolizumab plus Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma
- Primary refractoriness to atezolizumab plus bevacizumab in hepatocellular carcinoma, as defined by SITC criteria, is associated with poor clinical outcomes.
- Tumour microenvironment profiling reveals an immunosuppressive phenotype characterized by high myeloid infiltration, reduced interferon-γ signalling, and T-cell depletion.
- The combination of systemic inflammation and low IFN-γ signature expression strongly predicts primary refractoriness and may inform therapeutic decision-making.
Engineering a multimodal protease inhibitor for respiratory indications
Formulation development for biologics
From Cell Therapy to Vaccine Development: The Role of Mesenchymal Stromal Cells
Generative AI for Inverse Problems in Biomedical Computational Microscopy
Advanced microscopy techniques, including three-dimensional, super-resolution and quantitative phase microscopy, remain at the forefront of biomedical discovery. These methods enable researchers to visualise complex molecular processes and interactions at the level of single molecules or molecular complexes, capturing yet unseen information and pushing the boundaries of our understanding of health and disease. These innovations have been made possible, among others, through rapid progress in biophotonics, as well as computational processing and analysis of image-based data. However, advanced biophotonics comes at the cost of complex equipment, as well as difficult and lengthy data acquisition and necessitates highly-trained personnel. We demonstrate in several works that this hurdle can be addressed using generative and discriminative AI algorithms by formulating the conversion from conventional microscopy modalities like widefield, to advanced like super-resolution, as a set of inverse problems. We show that incorporating nuance of the data domain into the algorithm design, as well as leveraging synthetic data pre-training, leads to better performance in these algorithms. Among other examples, we demonstrate how Generative AI algorithms can be utilised for Virtual Staining of virus infection in cultured cells, allowing for quasi-label-free detection of infected cells.
ISB 2001, a First-in-Class Trispecific BCMA and CD38 T Cell Engager Designed to Overcome Mechanisms of Escape from Multiple Myeloma Treatments
Optimization of a Next Generation FcRn Inhibitor Fused to an Albumin-Binder for Improved IgG Clearance
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Advances in HLA/MHC Molecular Design and Engineering for Immunological Research
Major Histocompatibility Complex (MHC) molecules, referred to as Human Leukocyte Antigens (HLA) in humans, constitute a highly polymorphic family of cell surface glycoproteins. These molecules present intracellularly processed peptide antigens by forming stable MHC–peptide complexes. Following assembly, the complexes are trafficked to the cell membrane, where they are recognized by antigen-specific T cell receptors (TCRs), thereby triggering downstream adaptive immune responses.Given the central role of MHC molecules in antigen presentation and TCR recognition, they have become indispensable tools for TCR-based therapeutic research. To support this growing demand, KACTUS has developed a comprehensive portfolio of high-quality recombinant MHC products, including MHC monomers, tetramers, peptide-ready MHCs, as well as custom production services for both MHCs and TCRs. Our offerings span a broad range of MHC alleles and clinically relevant targets such as NY-ESO-1, KRAS, and AFP, providing versatile solutions to advance drug discovery and immunotherapy development
Discovery of pHLA targeting T cell engager
High-Throughput Production and Deep Characterization of VHH Antibodies: Unlocking Biophysical and Functional Insights for AI/ML-Driven Therapeutic Discovery
Panel Discussion: Finance & Investment for Start Ups
Targeting TNFR2 for Therapeutic Purposes
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Senior Representative, Lonza
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Attenuated cytokine antibody fusions for enhanced anti-tumor activity
Camyotopes: Next-Generation Immunotherapy Targets and their Development into an mRNA-LNP Colorectal Vaccine
- Dark genome immunotherapy target discovery based on profiling over 1500+ tumor biopts and TME evaluations
- Identification of highly-shared, presented, tumor-specific "camyopeptides"
- First glance at immunological responses revealing first-in-class potential of shared tumor targets
- Deals & product pipeline in CRC: mRNA-LNP vaccine
Designing Potent TCR-based T Cell Engagers for Cancer Immunotherapy with Generative AI
Etcembly is the first company to leverage generative AI to discover and engineer a T cell receptor (TCR) to picomolar affinity. We formatted our lead PRAME targeting molecule, ETC-101, into a trispecific T cell engager and demonstrated that ETC-101 specifically redirected T cell killing of PRAME-positive cancer cells only, while demonstrating a promising safety profile with no detectable off-target effects. Our data highlights the efficacy of ETC-101 as a novel drug candidate for the treatment of a wide range of PRAME-positive malignancies.
Drug conjugates targeting HER2 based on engineered affibody molecules
Affibody molecules are small, engineered scaffold affinity proteins that can be site-specifically loaded with cytotoxic drugs, producing homogenous conjugates with a desired drug-to-affibody ratio. The presentation will focus on targeting HER2 with affibody-based drug conjugates. It will describe how variations in the type of cytotoxic payload, both tubulin and topoisomerase inhibitors, as well as the drug load per affibody, influence biodistribution and in vivo cytotoxic efficacy.
Drug Discovery from Bench to Bedside: The Story of Anti-Factor XI Antibody Abelacimab (MAA868)
- Abelacimab (MAA868) is a monoclonal antibody targeting Factor XI, which promises a paradigm shift towards safe, long-acting thrombosis prevention, without the bleeding risk inherent to current anticoagulant drugs
- The presentation traces the discovery journey of abelacimab - from the initial target hypothesis through the identification of its unique mechanism of action, pivotal preclinical findings, and first-in-human clinical proof-of-mechanism.
- Abelacimab is currently undergoing active clinical evaluation in Phase 3 trials.
Insulin neoepitopes as biomarkers and potential therapeutic targets in type 1 diabetes
Latest Developments in the USA under the Trump Administration and Robert F. Kennedy Jr. at US-FDA: Widespread Layoffs, Guidance Priorities, and Broader Implications for Biosimilars
Powder Power: Transforming Biologic Modalities with Dry Formulations
Biologic therapies are transforming medicine, but their full potential is often limited by challenges in stability, storage, and delivery (especially for complex modalities like cell and gene therapies).
Dry powder formulations offer a promising solution, enabling enhanced stability, simplified logistics, and new routes of administration, including needle-free options like nasal delivery, that can improve patient access and compliance.
By rethinking formulation from the ground up, we can unlock new possibilities for advanced therapies, accelerating innovation and expanding the reach of life-changing treatments.
Antibody Discovery Beyond Binding: Functional Screening for Therapeutic Relevance
Biosimilar Market Sustainability Panel
First-in-class anti-TRPV6 antibody as a new therapeutic agent in oncology
Insights into Successful Industrial Clinical Collaborations
Machine Learning–Guided Protein Engineering of Picomolar Affinity Soluble T Cell Receptors
- Soluble TCR engagers enable high-affinity targeting of disease-relevant antigens, thus representing a promising therapeutic modality for oncology, autoimmunity, and infectious disease. However, affinity maturation of soluble TCRs (typically requiring a million-fold enhancement) is complicated by specificity challenges.
- Here we describe a pipeline that utilizes data from diverse DMS libraries, which include both on-target and off-target selections, to train several machine learning models. We then use their predictions to guide the design of improved TCR variants.
- Our machine learning–guided protein engineering approach enables the rapid identification of picomolar affinity TCRs with high levels of specificity.
Minimizing Polysorbate Degradation with Pfanstiehl’s Histidine - Case Study Presentation & Challenges of Formulating Complex Biologics
Polysorbate degradation is a persistent challenge in biologics formulations, often driven by trace metals contamination such as iron (Fe) and copper (Cu) often found in excipients. Pfanstiehl's highly processed & purified excipient grade amino acids , refined to remove trace metals to single-digit parts per billion, offer a solution. In a customer-developed case study, the use of Pfanstiehl's High Purity Low Endotoxin Low Metals L-Histidine successfully prevented polysorbate degradation under high-temperature accelerated stability conditions, demonstrating its effectiveness in preserving surfactant integrity. The presentation will also cover some aspects of challenges of formulating complex Biologics.
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Unlocking the Clinical Potential of Immunoglobulin G Glycosylation through Integration of Large-Scale Population Data and Mechanistic Insights
- Changes of IgG glycosylation in aging and disease (IgG glycans as biomarkers)
- Functional role of IgG glycosylation in the immune system (IgG glycans as functional effectors of inflammation)
- Targeting IgG glycosylation
- In vitroto fine-tune therapeutic IgG glycosylation
- In vivoto fine-tune serum IgG glycosylation by lifestyle and medical interventions
A novel linkerless ADCs platform for the production of new Auristatine-based drugs
The field of Antibody-Drug Conjugates (ADCs) has been flourishing for the last two decades, with increasing investments and a surging role in anticancer treatments. At the same time, research in the field has been aimed at enhancing their therapeutic windows, by controlling the effective delivery of the cytotoxic drug. However, despite the thriving innovations, the ADC technology has remained mostly unchanged since its introduction, always being based on the same model – a mAb, a linker (preferentially cleavable), and a highly potent drug – and following central dogmas built through the years. Reflecting on these points, we here introduce a new format of ADC, a linker-less one, obtained by turning the bioconjugation reaction into a synthetic step for the one-pot generation of a cytotoxic compound directly on the monoclonal antibody starting from two non-toxic fragments.
Antibody Secreting Cells Repertoire for Drug Discovery, Potential & Reality
Drug therapies based on Monoclonal Antibodies are an incontestable success for patients, but the rapid generation of potent antibodies remains a challenge. Secreted antibodies from ASC appear to be promising but require new technologies to be addressed and have yet to demonstrate a clear advantage over traditional display antibodies. To interrogate the antibody secreting cells (ASC) repertoire we optimized a single cell droplet microfluidic pipeline to increase the robustness. For the display antibody repertoire, we used the traditional pipeline based on single B cell (sBC) technology that combines the use of a FACS (Fluorescent Active Cell Sorting) and scRT-PCR (single cell Reverse Transcriptase PCR). We also evaluated an optimization of this sBC pipeline by replacing the scRT-PCR by a scRNA-Seq based on a 10x Genomics. Based on these two pipelines, we elaborated a head-to-head comparison of the antigen affinity of their respective antibodies.
Conquering The Last Frontier: Developing Ion Channel Modulating Antibodies
Ion channels are an important target class implicated in several untreated or poorly treated diseases. Despite the unmet need and the potential of monoclonal antibodies (mAbs) in this domain, no mAbs targeting ion channels have achieved clinical approval or are in clinical development. Maxion has shown that small cysteine-rich miniproteins (knottins) with ion-channel modulating activity can be inserted into antibody CDRs to create a novel mAb format called KnotBodies. KnotBodies maintain the ion channel activity of knottins while benefitting from the optimal drug-like properties of antibodies. This presentation will illustrate the discovery and optimisation of KnotBody inhibitors to therapeutically relevant ion channel targets.
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Use of AI-assisted Discovery Platform for Transcriptional Gene Regulation by Nuclear Small RNAs
- Small RNAs regulate transcription by epigenetic mechanism in cellnucleus by targeting promoter associated RNAs.
- Interactions of nuclear RNAs is very complex and RNatives has usedAI/ML to pinpoint the most effective RNAs
- RNatives is developing therapeutic small RNAs for various indications,including Ophthalmology, Metabolic disease, Oncology and Cardiovasculardisease
Create your personal agenda –check the favourite icon
Overcoming key barriers to making biologics magic bullets
Current biologics are striking precision therapeutics, quite magical in design, specificity and functionalities
But not so much once in the body where barriers can thwart target access, precise targeting & full efficacy
Need to define real targeting and why we fail so often. What are the main barriers in vivo? How do they limit efficacy and expand toxicities? What can be done?
An active delivery paradigm for biologics, drugs and even nanoparticles to penetrate one solid tissue in minutes with>50% of iv dose & 1000x more potency.
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Senior Representative, Lonza
Keynote Panel Discussion: Next Generation Antibody Formats
· Exploring the current state of antibody modalities and emerging therapeutics
· Advances in established formats: next generation bispecifics and ADCs
· The potential of AI in antibody engineering – what place does this technology hold in antibody development?
A Single Punch to Rewire Immunity: Reprogramming the Tumor Microenvironment via Metabolic Intervention
- PLT012, a monoclonal antibody blocking CD36-mediated lipid uptake,demonstrated strong anti-tumor activity in liver malignancies with durable protection.
- PLT012 remodelsthe tumor microenvironment through reduction of immunosuppressive cell populations and simultaneously boost effector cell populations with remarkable safety profile.
- Pilatus has established a robust translational framework—including ex vivo patient-derived tumor fragment testing, in silico analysis, and multiplex staining—to explore predictive biomarkers. This strategy supports rational patient stratification and increases the likelihood of clinical trial success before entering FIH.
Clinical mass spectrometry
Developability assessment of antibody modalities with complex antigen-binding regions
How to prevent protein aggregation through stabilizers and surfactants
Immunogenicity potential assessment at Novartis
Evaluating the immunogenicity potential of biotherapeutics is becoming increasingly important and challenging at the same time. The presentation will provide an overview over how Novartis is conducting immunogenicity potential assessment from the design space to the clinics. Categories and elements of this assessment will be presented, for example the mode of action of the drug, similarity to endogenous proteins, critical quality attributes or the immune status of the patient. The presentation will cover the immunogenicity risk assessment questionnaire as well as different types of assays which can be applied to support the selection of biotherapeutic candidates and to understand mechanistic root causes of immunogenicity.
Next-generation TCR-like antibodies with improved specificity profiles
In this talk, we introduce YUMAB’s advanced TCR-mimic discovery platform addressing the off-target-pHLA binding challenge. Employing our technology, we discovered highly specific, human antibodies against the cancer antigen WT1. Our antibodies outperform established references (e.g., 11D06, ESK1) in affinity and specificity without additional engineering. As a next step, we integrate these TCR-like antibodies with proprietary anti-CD3 antibodies to develop bispecific T cell engagers (“safeTY-engagers”). This innovative approach, funded by the BMBF (safeTY-engager, ID: 16LW0341), aims to enhance precision and safety in cancer immunotherapy.
Synthetic Genetic Systems for Improving Protein Expression
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Turning enzymes into effective enzybiotics
This presentation explores the innovative approach of engineering enzymes to develop enzybiotics—enzyme-based antibacterial agents—as a promising alternative to traditional antibiotics. It highlights how specific modifications, such as domain swapping, mutagenesis, and fusion with targeting peptides, can enhance enzyme stability, specificity, and bactericidal efficiency. The talk also covers recent successes in combating multidrug-resistant pathogens and discusses future directions for optimizing delivery, broadening the antibacterial spectrum, and overcoming resistance mechanisms.
Unlocking New Target Opportunities In Oncology
Development of Novel Peptides to Significantly Prevent Alpha-Synuclein Fibril-Induced Neurodegeneration
- Pathogenic Mechanism of α-Synuclein Fibrils: α-Synuclein fibrils induce cytotoxicity in the brain leading to progressive neuronal loss, a hallmark of Parkinson’s disease, for which we designed an in-vitro drug screening model.
- Innovative Peptide-Based Inhibition: Using structural bioinformatics, we designed novel peptides that block α-synuclein fibril entry into neural cells, designed high-throughput binding and cytotoxicity studies that successfully prevents internalization of fibrils and halts neurodegeneration.
- Therapeutic Potential: Our findings demonstrate that these peptides mitigate the spread of toxic α-synuclein species, enhancing neural cell survival and offering a promising therapeutic avenue for Parkinson’s disease and related synucleinopathies.
Fibrils of α-synuclein, an intrinsically disordered protein (IDP), are major pathogenic agents in several neurodegenerative diseases, including Parkinson’s disease. The propagation of these α-synuclein fibrils between neuronal and glial cells exhibits prion-like behaviour, rendering them highly cytotoxic as they induce progressive neuronal loss, a hallmark of Parkinson’s disease. These fibrils form through the aggregation of α-synuclein oligomers into insoluble higher-order fibrillar structures, stabilizing fibril growth and conferring toxicity. We employed a structural bioinformatics approach to determine fragment complexes with a stable β-sheet geometry and to generate dimer structural ensembles using its energy landscape. Using this method, we designed various novel peptides that effectively reduce α-synuclein aggregation synucleinopathies. The binding of these peptides block the entry of α-synuclein fibrils into neural cells, thereby preventing their cytotoxic effects and mitigating the spread of neurodegenerative pathology. Our detailed bioanalytical investigation demonstrated that these designed peptide inhibitors significantly reduce the cellular internalization of toxic α-synuclein species, thereby limiting the spread of fibrils in the neural microenvironment. In an in-vitro model of the disease, we introduced these peptides and observed a significant reduction in prion-like cellular uptake and processing of α-synuclein preformed fibrils, resulting in enhanced survival of neural cells. This advancement not only provides a novel therapeutic approach for Parkinson’s disease but also sets a precedent for targeting protein aggregation in other neurodegenerative conditions.
Fc-enhanced monoclonal antibody therapeutics to activate the tumour microenvironment
Antibody design to fine tune effector functions harbours potential to improve therapeutic effects. This talk will focus on two antibody Fc modification approaches that consider the immune composition of the tumour microenvironment: IgG Fc-engineering and generation of antibodies with IgE class Fc regions. Cancer biology and immunology guided antibody design can harness immune effector mechanisms and may hold promise for precision medicine, especially for patients with aggressive and treatment-resistant cancers.
Immunogenicity Assay Development for Antibody Therapies
In vivo models to predict clinical outcome of multispecific cancer therapeutics
Optimised Viral Vectors for Efficient Gene Expression and Downregulation in Immune Cell Engineering
Role of automation in Protein mass spectrometry: from lead discovery to bioprocess modeling
Modern biopharmaceuticals, a substantial part of Roche's Large Molecule Research (LMR) project portfolio, are highly engineered, often bispecific proteins that address complex modes of action for disease treatment. Mass spectrometry (MS) is a well-established technology, easily capable of identifying proteins and their potential side products. Automation of protein MS analysis has already been successful in applications that require repeated analysis of samples from one well-characterized protein, e.g., throughout process development of biotherapeutics in clinical development.
This talk will showcase the approach taken by Roche's LMR MS unit to enable high-throughput MS analysis for protein screening or process modeling applications that were previously too demanding due to sample diversity and sample numbers.
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VHP Ingress unveiled: Protecting Quality in Closed System for ATMP Manufacturing
ATMPs are very promising therapies for many diseases, from several cancer types to rare genetic disorders. Their type, nature and manufacturing processes are quite different, as well as the doses and way of administration. Due to this wide variety, the Bill of Material for manufacturing processes can be quite big and heterogeneous, from patient’s cells to sensitive materials such as media or specific reagents.
Isolators are a safe and compliant platform for ATMP manufacturing, being a closed system with a sound decontamination control of chambers and materials by H2O2 (VHP, Vapour Hydrogen Peroxide).
Material decontamination by H2O2 can be challenging when materials such as the above must be transferred into the A zone. How to overcome those challenges and how to ensure a safe and compliant material transfer to the isolator chamber? SKAN will show VHP ingress studies on typical raw materials for ATMP as well as current ways of fast and safe material transfer
Bioanalytical studies of oligo based therapies
Oligonucleotide-based therapeutics, including small interfering RNA (siRNA) and antisense oligonucleotides (ASOs), represent innovative modalities with unparalleled specificity for modulating gene expression. These molecules occupy a unique position between small molecules and biologics: their chemical engineering and ability to generate metabolites align them with low molecular weight compounds, while their nucleic acid backbone and tailored features for enhanced cellular uptake can provoke immune responses. This duality introduces complex challenges for drug development, requiring specialized approaches to evaluate pharmacokinetics (PK) and immunogenicity.
This session will highlight bioanalytical methods for PK assessment, including hybridization-based techniques and LC-MS workflows, to effectively quantify oligonucleotides and their metabolites. Immunogenicity risks associated with siRNA and ASOs will also be addressed, focusing on the detection of anti-drug antibodies (ADAs) specific to the oligonucleotide backbone or conjugates designed to improve cellular uptake. Strategies to reduce immunogenicity risk, such as chemical modifications, advanced delivery systems, and sequence optimization, will be discussed, ensuring that therapeutic efficacy is maintained. Additionally, the presentation will explore reliable methodologies for measuring ADAs in clinical settings, emphasizing the importance of ADA monitoring to optimize safety and therapeutic benefit for patients and advance the field of oligonucleotide-based drug development.
CMOs as Strategic Partners: The Evolving Landscape of Fill-Finish in Commercial Biologics
As the commercial biologics landscape grows increasingly complex, fill-finish Contract Manufacturing Organizations (CMOs) have become critical strategic partners in ensuring product quality, supply continuity, and speed to market. This presentation will explore the evolving role of CMOs in commercial biologics manufacturing, highlighting key trends, emerging technologies, and operational challenges. Drawing from real-world experience, the talk will examine best practices for building resilient, collaborative partnerships with CMOs and provide strategic guidance on navigating capacity constraints, regulatory expectations, and global supply chain risks. Attendees will gain practical insights into how to future-proof their fill-finish strategies in an ever-changing environment.
Engineering Bispecific sdAb-based Antibodies
From Data to Discovery: How Computational Modeling Enhances Wet-Lab Insights in Cancer
Integrating large-scale multi-omics datasets (RNA-seq, ATAC-seq, 4C-seq,
proteomics) with small-scale, wet-lab derived datasets to identify the most promising
regulatory targets for experimental validation.
Using computational modeling to select the most promising hypotheses, design more
targeted experiments, and minimize unnecessary trial-and-error in the lab.
How predictive models, guided by wet-lab data, transform even small-scale,
lab-specific datasets into meaningful and targeted predictions through a feedback
loop that accelerates discovery.
IgCheck: an LLM-Powered Platform for Early Immunogenicity Risk Assessment in Biotherapeutics
IgCheck is an LLM-driven solution designed to assess immunogenicity risks in biologic drug development. By leveraging large-scale literature mining and advanced peptide extraction algorithms, IgCheck identifies known pathogenic sequences that may trigger immune responses when present in therapeutic proteins. The platform uses contextual analysis to stratify peptides by immunogenic potential, enabling early-stage candidate screening and re-engineering. On the test set of manually annotated papers, the system achieved over 80% recall (over 90% for in-text-based) and high precision in peptide extraction and classification.
Profiling and characterizing O-glycosylation in the hinge region of immunoglobulin A by bottom-up mass spectrometry.
IgA Nephropathy is an autoimmune disease which has been recognized as an important cause of chronic kidney disease and end stage kidney failure. This condition is marked by the production of aberrantly glycosylated IgA1 by memory B and plasma cells. Therefore, characterizing the glycosylation pattern of IgA1 is crucial.
IgA1 undergoes post-translational modification through O-glycosylation at six serine and threonine residues in the hinge region. This results in a wide heterogeneity of O-glycoforms, which can be categorized into two groups: galactose-deficient (where at least one GalNAc residue is not linked to a Galactose residue) and non-galactose-deficient.
An automated profiling workflow is employed to classify the O-glycosylation pattern of IgA1 using LC-MS after tryptic digestion. Additionally, an in-depth characterization method has been developed to pinpoint the galactose-deficient sites. This method combines specific enzymes, IgASAP™ Sub1+2 (Genovis), and O-glycosidases, along with EAD fragmentation, a feature of the ZenoTOF 7600 mass spectrometer from Sciex.
Streamlining Biosimilar Development
The making of potent and developable Multiclonics® antibodies
Multispecific antibodies offer unique opportunities through the combination of binding arms to different epitopes or antigens. These engineered antibody formats can result in specificities or functions that are unachievable by classic monovalent antibodies. To generate successful drugs, multispecific antibodies need to be safe and active but also developable and manufacturable. This presentation describes our approach to screen through large panels of Multispecifics that meet all these requirements.
Translating Bispecific Costimulatory Antibodies into First-in-Human Trials: Bridging Preclinical Development to Clinical Application
Engineering Human Cell Surface Receptors for Epitope Editing and Selective Targeting
Generation of antibodies for HCP monitoring
Immunogenicity Publication Bias and Its Consequences for Predictive Models: A Call for Transparent Reporting
Mass spectrometry-based biodistribution of biotherapeutics: an alternative to radio-biodistribution
Moving away from Acetonitrile and TFA to greener eluents in Biopharma LC-MS
With growing awareness of the environmental impact of laboratory operations, the principles of green chemistry are gaining momentum within the analytical community. Although not typically viewed as major sources of greenhouse gas emissions, reversed-phase liquid chromatography (RP-LC) reliant analytical labs consume large volumes of environmentally hazardous solvents such as acetonitrile (ACN) and halogenated additives. In this study, we present a biodegradable, less toxic solvent system for RP-LC-MS that replaces the conventional solvent mixtures, by combining an uncommon but highly effective solvent for RP and an exceptionally strong non-PFAS ion pairing agent. The resulting system demonstrated superior chromatographic resolution and mass spectrometric sensitivity compared to the ACN standard, while significantly reducing organic solvent usage and CO₂ emissions. This approach supports a broad range of biopharmaceutical applications, including intact, subunit, and reduced antibody analyses. The method offers a practical and scalable path toward greener LC-MS workflows in therapeutic protein analysis.
Non-Viral Protein-Based Gene Delivery – Imaging Assays to Depict the Intracellular Journey of DNA
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Inducing antigen-specific immune tolerance with chimeric non-classical HLA molecules inspired by pregnancy
Panel Discussion: 2025 In Review and Trends into 2026
· Reviewing key advances in recent trends for antibodies and immunotherapies
· Current status of projects outside of oncology: advances in autoimmune conditions, treating inflammation and infectious diseases
· AI and it’s impact on the industry – have we arrived at a tipping point?
· The drive for accessibility and patient centric care
· Europe’s place in the global market: Europe’s pricing and regulatory framework, and changes in the US research landscape
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