Validation and Implementation of Alternate Sterility Tests for HCT/Ps


Webinar training to provide guidance for the validation and implementation of alternate sterility testing methods of human cells, tissues, and cellular and tissue products (HCT/Ps) in a manner compliant with cGMPs and the new requirements in biologics regulation 21 CFR 610.12. Concepts for implementation of a sterility testing program are provided so that these tests are performed appropriately, are adequately investigated when deviations occur, and are maintained in a validated state over the product lifecycle, whether in the original test laboratory or transferred to other locations.

Why You Should Attend:

As you know the traditional 14-day sterility culture methods are problematic for many HCT/Ps because of the nature of the live cell sample matrices often coupled with short expiry periods. Therefore alternate and rapid technologies for sterility testing are increasingly being considered for these products.

In this training you will be able to learn about some of the alternate technology platforms currently available which have been advantageous for cell-based products. You will be able to identify the major activities involved in the selection and validation plan including: initial assessment activities, critical specifications to evaluate, how to design feasibility studies, and requirements for equipment qualification.

Understand the difference between method suitability and method validation and implications for early phase investigational products versus approved products or BLA requirements.  Identify the main parameters (e.g. Specificity and Limit of Detection) required in the method validation phase and how to test for those parameters. Learn how to select the types and number of test strains including considerations for the cell collection source such as bone marrow or cord blood (CB).

Understand test sample volume requirements, e.g. where the final product unit is one (N=1), or more than one (N>1), and approaches when the sample volume available for testing is limited. Learn the requirements for test interpretation and identify key elements and requirements for investigation of positive tests, especially if discovered post-infusion.

Key Topics:

  • Regulatory requirements and guidelines
  • Overview of alternate detection platforms
    • Growth-based
    • Viability-based
    • Cell component-based
    • Nucleic acid amplification
  • Validation overview
    • Initial due diligence assessments
    • Feasibility (Proof-of-concept)
    • URS, IQ, OQ, PQ
    • Method validation
  • Implementation
    • Investigative Phase 1 – 3 versus approved products
    • Precautions against microbial contamination
    • Culture media and incubation
    • Re-qualification / Verification / Method transfer

Who will benefit?

Manufacturing and Laboratory Staff, Quality Control, Quality Assurance, Validation, Regulatory

Instructor Profile:

Timothy D. Wood has over 25 years experience in Quality Control Microbiology in cGMP industry. Tim is founder and Principle Consultant at Cell Therapy Microbiology Consulting designed to assist the cell therapy industry in developing and improving microbiology methods and contamination controls. For over 13 years Tim was at Dendreon helping to get the autologous cellular therapy product PROVENGE through pivotal trials, FDA approval, and expanded to multiple cGMP facilities. Tim developed and validated the BacT/Alert sterility test for PROVENGE and other immunotherapy products in-lieu of the compendial culture methods thereby improving method specificity and decreasing test detection time. Tim has worked as a Microbiologist at several companies including ICOS, Xcyte Therapies, CellPro, and Abbott Laboratories. Tim received his Bachelors degree in Biology from Pacific Lutheran University, Tacoma, WA.


Cell Therapy Microbiology Consulting, LLC