Advanced therapy medicinal products or ATMPs, are among the fastest growing areas of biotherapeutics, encompassing gene therapies, viral therapies, vaccines and cell therapies. The control strategies are very different from more traditional biologics, with quantitation of potency posing one of the greatest challenges. In this webinar, representative case studies will demonstrate considerations in the conception, development and validation of potency assays — mostly cell-based — for representative ATMPs. The use of different analytical technologies and complex assay schema will be provided along with consideration of timing, phase-appropriate validation (qualification) considerations and assay lifecycle guidance as the product moves through the clinical development phases.
Topics for discussion will include data and statistical considerations and how data may be processed to extract relevant insights and monitor attributes such as relative potency. The implications of global regulatory guidance and precedence will also be discussed.
Register to learn about the conception, development, validation, matrixed approaches and assay lifecycle of potency assays.
Jeff Patrick, PhD, Senior Director of GMP Operations, BioAgilytix
Jeff Patrick has served as Senior Director of GMP Operations at BioAgilytix in Durham, NC for three years. Prior to that, he served as Associate Director of the CMC group at Covance in Greenfield, IN for four years, and earlier held several positions in biologics development over 20 years. These roles included leadership in process analytical development, CMC, analytical development, early phase discovery and manufacturing of biologics. Jeff also applied his expertise in metabolomics, proteomics and biomarker utilization to the development of biologics. He has published more than 30 papers and reviews and earned his PhD from Purdue University in analytical chemistry and an MS in chemistry from the University of South Carolina.
Lynn Kamen, PhD, Scientific Officer, Executive Director, BioAgilytix
Lynn Kamen earned her Ph.D. in Immunology at the University of Michigan and completed a postdoctoral fellowship at the University of California San Francisco. She has spent the past decade working in drug development supporting both large and small molecule formats from early target discovery through clinical development. Most recently, she was a principal scientist at Genentech where she supported large molecule and novel modality bioanalysis including PK, immunogenicity, and biomarker.
Who Should Attend?
- Analytical Development Scientists
- QC Scientists
- Gene and Cell Therapy Lab Managers
What You Will Learn
Attendees will learn:
- Considerations in developing potency assays for advanced therapy medicinal products (ATMPs) vs mechanism of action and regulatory guidance
- Technologies to employ
- Data processing and acceptance criteria consideration
- Matrixed approaches and phase-appropriate lifecycle considerations
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across industries and disease states.