Sterility Testing for Cellular Therapies: Updates and Challenges. What should we be doing?

Saturday, October 19, 2024

9:45 AM - 10:45 AM

Location: 320

CE: 1 CME (AMA Physician Credit) / 1 CE (Non-Physician Credit)

Program Chair(s)

J. Wade Atkins, MS, MLS, SBB, CQA, CABP(H)

Supervisor, QA and RA
NIH/CC/DTM
Bethesda, Maryland, United States

Disclosure(s): No financial relationships to disclose

PDF

Speaker(s)

Dr. Anna Lau, PhD, D(ABMM) (she/her/hers)

Chief, Sterility Testing Service
NIH/CC/DLM
Bethesda, Maryland, United States

Disclosure(s): No financial relationships to disclose

PDF
Elizabeth Lessey-Morillon, PhD, RAC (she/her/hers)

Senior Biologist
Center for Biologics Evaluation and Research; Office of Therapeutic Products; Office of Cellular Therapy & Human Tissue CMC; U.S. Food and Drug Administration

Disclosure(s): No financial relationships to disclose

PDF

Disclosure(s):

J. Wade Atkins, MS, MLS, SBB, CQA, CABP(H): No financial relationships to disclose

Dr. Anna Lau, PhD, D(ABMM): No financial relationships to disclose

Elizabeth Lessey-Morillon, PhD, RAC: No financial relationships to disclose

There are core regulations that the use of human cells and tissues must not introduce communicable disease, either from contamination, cross contamination or mix ups. The FDA has clarified that distributing products with objectionable microorganisms is the spread of communicable disease. There are several approaches to sterility testing that include both USP and automated or Rapid Microbiology assays. A review of updates to Sterility Testing requirements for HCTPs (361s) and Biological Products (351s) for procedures or processes that are designed to ensure product sterility will be reviewed in context to FDA requirements and USP Compendial methods. This session will also review common practices and hurdles for implementing the USP sterility testing requirements for these products that have unique constraints such as short product shelf life and sampling size. The panelists will host a discussion session on the similarities and differences between regulatory requirements found in 21 CFR 211.84 (d) (6), 21 CFR 610.12, 21 CFR 1271.1 (a) and 21 CFR 1271.220.
An update on several new USP chapters that have direct impact on biologics if they fall into the category of “short shelf-life products”, will also be provided and include:
• < 86> Bacterial Endotoxins Test Using Recombinant Reagents
• < 72> Respiration Based Methods for Short Shelf-Life Products (aka BacT/ALERT)
• < 73> ATP Bioluminescence for Short Shelf-Life Products
• < 1071> Rapid Micro Methods
NOTE: We would like to invite and FDA speaker from CBER/OTAT. We have recommendations on who should be invited from the FDA.

CABP CE Eligible

Learning Objectives:

Describe performance differences between sterility testing methods ranging from gold standard USP testing and validation requirements for alternative test methods (eg. BacT/ALERT, Mycoplasma PCR).
Determine the current level of compliance within their organization for sufficient sterility testing for human cells and tissues regulated as HCTPs or Biological Drug Products.
Discuss strategies that ensure the sterility program in their organization is meeting regulatory requirements and the safety needs of all product recipients.