Speaker Spotlight: Monitoring CAR-T Persistence by Droplet Digital PCR

Wednesday, October 19, 2022

9:30 AM – 10:30 AM ET

Location:Spotlight Stage 2, Exhibit Hall A&B

Moderator(s)

Kate Herr, M.S.

Scientist
Janssen R&D/ Johnson & Johnson
Norristown, Pennsylvania

Spotlight Speaker(s)

Shian-Jiun Shih, PhD

Consultant
Tessa Therapeutics
Foster City, California

Handouts

Learn how Tessa Therapeutics uses droplet digital PCR to develop, qualify and/or validate assays for CAR-T cell therapy products. Dr. Shih will present the development of a ddPCR-based assay as a lot release assay for viral copy number (VCN) determination and its modification into a pharmacokinetic assay for CAR-T persistence after being infused into patients. She will briefly cover how Tessa developed these assays as well as conducted fit-for-purpose assay qualification. The ddPCR assay platform also supports a biomarker assay to examine the presence of the transgene in secondary malignancy if it occurs in treated patients.

Learning Objectives:

Upon completion, participants will be able to understand the principles of droplet digital PCR and the advantage of ddPCR-based assays
Upon completion, participants will be able to understand how droplet digital PCR be used for lot release, product characterization and/or biomarker assays in cell therapy.
Upon completion, participants will be able to develop droplet digital PCR assays that address critical assay parameters such as specificity, accuracy, precision, linearity, and range.
Upon completion, participants will be able to develop multiplex droplet digital PCR assays that measure two genes of interest in the same assay