Release, redefined: QC testing across in vivo and ex vivo CAR-T
Webinar
In this webinar, you will learn:
- CAR-T therapies use both ex vivo and emerging in vivo approaches with lentiviral vectors to enhance patient access and treatment impact.
- Quality control testing has evolved across both paradigms: ex vivo requires fast release testing on cell product; in vivo approaches prioritize characterization of the viral vector.
- A new process for outsourced ex vivo CAR-T release testing is designed to meet the demands of clinical and commercial scale.
Detailed description:
CAR-T therapies advance via ex vivo manufacturing and emerging in vivo methods, with lentiviral vectors key in both. Ex vivo allows precise cell engineering and release testing; in vivo simplifies treatment by engineering cells within patients. These complementary approaches expand patient access and impact.
This webinar will highlight how quality control (QC) testing strategies for drug product evolve across both in vivo and ex vivo paradigms —focusing on identity, potency, sterility, and safety assays while introducing a new operating framework for fast, consistent ex vivo CAR-T release testing.
Speakers
Leyla Diaz, Ph.D.
Merck
Technical Consultant, Scientific and Regulatory Consultancy
Leyla Diaz, PhD is a Technical Consultant in Scientific and Regulatory Consultancy supporting the BioReliance® Contract Testing Services. She provides scientific and regulatory support in biosafety testing and characterization of biological therapeutic products for global customers. Leyla has 20 years of industry experience in product and assay development of therapeutic antibodies and vaccines. Leyla received her doctorate in Microbiology from the University of Maryland, College Park followed by a postdoctoral fellowship at the University of California, San Francisco.
Kyle Reder
Merck
Segment Strategy Manager for Cell & Gene Therapy
Kyle Reder is a segment strategy manager for cell & gene therapy, supporting BioReliance® biosafety testing services. With more than 10 years of experience as a biologist, technical specialist, and product manager supporting cell and gene therapy manufacturers, Kyle provides insights into business and technology trends across the CGT landscape. Kyle has a B.Sc. in biomedical sciences from the University of Lynchburg.
Pharma and biopharma manufacturing
- Cell therapy manufacturing
Duration:1h
Language:English
Session 1:presented June 2, 2026