Pre-Conference Workshop Day

Monday July, 25 2022 | Boston, MA

Workshop A

How to Assess Stability Indicating Methods of
Cryopreserved CAR T Cellular Products

9am - 12pm 

Potency tests, along with other tests, are performed as part of product conformance testing, comparability studies, and stability testing. (Guidance for Industry: Potency Tests for Cellular Gene Therapy Products). Per the Draft Guidance for Industry on Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, the shelf-life for a drug product should be supported by stability studies. In order to determine stability, you should use a potency assay to establish expiry dating for licensure (21 CFR 610.53). Potency assays used to establish stability and expiry dating should be demonstrated to be stability
indicating.

This workshop will be a case study for how to assess stability indicating methods of cryopreserved CAR T cellular products.

Sean Madsen
Katherine Matsuda

Sean Madsen
Senior Scientist, Potency and Cellular Function, Cell Therapy Analytical Development
Bristol Myers Squibb

Katherine Matsuda
Scientist
Bristol Myers Squibb

Workshop B

Regulatory 101 – Defining and Measuring Potency

1pm - 4pm 

Potency remains a critical regulatory bottleneck when it comes to the approval of cell therapy products, with many recent examples of submissions being rejected due to concerns surrounding potency.

Attend this workshop for a detailed discussion on the current regulatory guidelines for cell therapy products to enhance your clinical strategy by addressing common problems faced by others, including:

• How do you, and how can you, align cell therapy potency assays with ICH and USP guidelines?

• What are the pro’s and con’s of ‘absolute potency’ assays versus ‘relative potency’ assays?

• For CAR-T therapeutics, what would be optimal functions/activities to ‘harness’ as potency assays?

• For potency assays:
- Do we need a reference standard?
- How would we use a reference standard?
- How would we source a reference standard?
- What about an Assay Control Sample

Michael Sadick

Michael Sadick
Senior Director, CMC Analytical Development
Precision Biosciences