LPC Snapshot - August 2022
Potency Testing in Cell and Gene Therapy Products
Read Article #LabPractices#LabPracticesandQualityOperations#29.7
Ted Kieffer, MD, MS
Clinical Pathologist/Transfusion Medicine Specialist/Clinical Microbiologist
Apheresis Collections Expert
ISCT LPC ESP Member
There has been a substantial discussion surrounding potency tests of Cell and Gene Therapy products - their necessity, value, and approach. To better understand potency tests, in this snapshot the LPC shares the regulatory and guidance text that relate to their governance and additional details that make standardization a continued challenge.