Carsten Krantz | Associate Director
novartis
Carsten Krantz, PhD, is a highly accomplished bioanalytical scientist with broad expertise across a spectrum of advanced methodologies, including LC-MS/MS, ligand binding assays, ELISA, MSD, and neutralizing antibody assays. Currently serving as an Associate Director at Novartis, he leads a global team in strategic outsourcing for biologics for pharmacokinetic, pharmacodynamic and immunogenicity assays while providing scientific expertise in method development and regulatory submissions. With extensive experience spanning preclinical and clinical studies, Carsten has implemented innovative bioanalytical strategies across multiple therapeutic areas and contributed significantly to regulatory dossiers. His academic grounding includes a PhD in Cell Biology, complemented by advanced biotechnology degrees, that highlight his multidisciplinary approach to bioanalytics.
Appearances:
Festival of Biologics Day 3 @ 12:20
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.
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