The recent regulatory approvals of adeno-associated viral (AAV) and lentiviral (LV) vector-based gene therapies, along with the expanding clinical pipeline for new cell and gene therapies, has created backlogs in manufacturing production.
Immunoassays are commonly used for bioanalysis during vector manufacturing and bioprocess development for titer and empty/full capsid ratios, critical quality attributes (CQAs) for process characterization, and process impurity analysis (also a regulatory requirement related to product safety). Traditional plate-based methods for these analytical characterization steps have numerous drawbacks including long incubation times, narrow dynamic ranges, and multiple manual manipulations, creating workflow bottlenecks in bioanalysis.
Immunoassays have consequently been identified as a target for improvements in analysis speed, accuracy, and sample volume consumption to speed up bioprocess development and manufacturing times, and conserve precious batch samples. In this webinar, we will discuss how advances in bioanalytical assays and technologies have improved immunoassay performance, closing the gap in assay drawbacks for cell and gene therapy manufacturing. Examples from Gyrolab® microfluidic, CD-based immunoassay platform will be presented demonstrating AAV titer, LV titer, and bioprocessing HEK 293 host cell protein impurity analysis improvements.
Through this webinar, attendees will learn about:
- Bioanalytical bottlenecks in viral vector manufacturing and bioprocessing
- Impact of increased regulatory demands, long assay times and large sample consumption on vector characterization
- Strategies for addressing immunoassay speed, accuracy, and sample volumes
- Performance of microfluidic-based immunoassays for LV and AAV titer and impurity analysis
Rob Durham, PhD
Director of Service and Scientific Support, Gyros Protein Technologies
Dr. Rob Durham is currently the Director of Service and Scientific Support at Gyros Protein Technologies. He has been with the company since 2010 but prior to joining the company he was a Gyros customer as a Sr. Principal Scientist in Translational Medicine at Pfizer. Rob received his Ph.D. in Pharmacology and Neuroscience from Michigan State University and completed a postdoctoral fellowship at Parke Davis Pharmaceutical development before making the move to Pfizer. Exploring the ways immunoassay technologies can be applied to problems in bioanalysis and biotherapeutic drug development has been a major focus in his career.
Johannes Stanta, PhD
Director of Bioanalysis, Freeline Therapeutics
Johannes Stanta is Director of Bioanalysis at Freeline Therapeutics. He received his Ph.D. from the University of Cambridge, focusing on the discovery of diagnostic biomarkers for neuropsychiatric disorders. He has more than 10 years of industry experience in small and large molecule Bioanalysis, supporting clinical and non-clinical programs. He is also leading the European Bioanalysis Forum’s Cell and Gene Therapy interest group where Bioanalytical labs across Europe share their bioanalytical challenges and best practices.
Katherine Hanson, PhD
Lab Manager, PPD Laboratories
Katherine Hanson, Ph.D. joined PPD in 2013 and is currently a lab manager at the PPD site in Middleton, Wisconsin. Her team specializes in development and validation of GMP assays for gene and cell therapy products with a focus on molecular biology techniques including qPCR, ddPCR, and Sanger sequencing.
Judith Greengard, PhD, RAC
Senior Scientific Fellow, Exploratory Analytical Development and Validation, Adverum Biotechnologies, Inc.