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 Per the Draft Guidance for Industry on Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, the shelf-life for a drug product should be supported by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

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
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