Evaluating Analytical Strategies to Quantify Capsid Titre: Towards a Platform-Method Approach to Accelerate AAV Drug Product Development



30th October 2024 | 10:00am EDT / 7:00am PDT / 2:00pm GMT / 3:00pm CET | Dr. Marilia Barros, PhD, Principal Scientist Biologics & Gene Therapy Drug Product Development at Regeneron and Laura Pala, Product Marketing Manager at Refeyn |BOOK FREE SEAT FOR THIS WEBINAR

Traditional capsid titre methods rely on ELISA which commonly suffers from long turnaround times, low throughput, and large volume sample requirements. This limits the application of ELISA-based methods to routine analysis, thus requiring development of alternative high-throughput (HTP) capsid titre methods. We have performed a comprehensive assessment on currently available orthogonal capsid titre methods using multiple serotypes at concentration range relevant in IND-enabling preclinical and first-in-human (FIH) clinical studies.

Presented by Dr. Marilia Barros, PhD, Principal Scientist Biologics & Gene Therapy Drug Product Development at Regeneron

Dr. Barros is an expert in biologics and gene therapy drug product development with over 8 years of experience in the pharma and biotech industry, providing primary support for therapeutic areas in early through late phase development projects and spearheading the development of parenteral dosage forms to enable clinical and commercial use. She received her PhD in Physics from CMU and has worked at NIST Center for Neutron Research and Memorial Sloan Kettering Cancer Center. At Bristol Myers Squibb, she developed and led internal and external scientific collaborations to drive key innovation that impacted the progression of the sterile products portfolio and investigated the colloidal stability of biotherapeutics to support drug development and new strategies of drug product formulation. Currently, she works at Regeneron as a Principal Scientist developing strategies to identify and implement new technologies to advance the pipeline and serves as CMC drug product formulation development lead for Regeneron’s gene therapy programs.

Followed by Laura Pala, Product Marketing Manager at Refeyn

Laura Pala is a Product Marketing Manager at Refeyn, where she oversees the Cell & Gene Therapy product portfolio. She brings a wealth of experience in product development and product management of scientific instruments in the nanomedicine and gene therapy markets, along with a background in various commercial roles. Laura holds a Ph.D. in organic medicinal chemistry, with her research focusing on targeted drug delivery systems. Additionally, she has prior experience working with nanoparticles for diagnostic purposes.

Sponsored by Refeyn

Refeyn pioneers analytical instruments that put molecular mass measurement capabilities within easy reach for scientists. Refeyn’s unique products measure the mass of individual proteins, nucleic acids, complexes and viruses directly in solution – providing vital insights for scientific discovery, R&D and therapeutics production.

Our instruments feature mass photometry technology, which uses light to quantify the mass of single particles in solution without labels, and macro mass photometry technology, which uses light to characterize large viral vectors. Providing intuitive data in minutes, mass photometry technologies help scientists solve their research questions, optimize R&D processes and focus on innovation.


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