Science & Innovation Forum - Should Clinical Microbiology Labs Perform Sterility Testing of Cell & Gene Therapy Products?

Please note: AABB reserves the right to make updates to this program.

Live Program Date: Thursday, September 8, 2022 - On-Demand Available

Presented by bioMérieux

BiomerieuxCell and gene therapies are quickly emerging as frontline therapeutics offered at major academic centers. Clinical microbiology laboratories are increasingly sought to assist with product sterility testing. Is this the appropriate lab for testing and what risks are assumed by the manufacturer? Listen to Dr. Anna Lau, Chief of the Sterility Testing Service, Department of Laboratory Medicine at the National Institutes of Health, discuss lessons learned at the NIH as she aims to bridge the gap between industry guidelines and clinical practices.

After attending this program, participants should be able to:

  • Discuss product sterility testing and Mycoplasma testing for various investigational new drugs encompassing cell and gene therapies, viral vectors, and radiopharmaceuticals.
  • Describe regulatory requirements and risks for product release testing in a clinical microbiology lab.
  • Intended Audience: CEOs, CFOs, Clinical Micro Labs, COOs, Directors, Facilities that perform molecular testing, Immunohematology Reference Labs (IRL’s), Laboratory Staff, Managers/Supervisors, Medical Directors, Physicians, Research Scientists, Residents/Fellows, Scientists, Students (MD, MT, SBB), Technologists
  • Registration

    This Science & Innovation Forum is complimentary to all, but registration is required. By registering for this AABB-hosted program you consent to have your information shared with the program sponsor, bioMérieux. Register here.


    Moderator: Derek Jacobs, Marketing Manager, bioMérieux


    Anna F. Lau, PhD, D(ABMM)Anna F. Lau, PhD, D(ABMM)
    Chief, Sterility Testing Service
    Department of Laboratory Medicine Clinical Center
    National Institutes of Health
    Bethesda, MD

    Dr. Lau is a board-certified clinical microbiologist through the American Board of Medical Microbiology. Dr. Lau earned her PhD from the University of Sydney, Australia, where her research focused on the development of novel diagnostic platforms for invasive fungal diseases. In 2011, she joined the NIH to complete a fellowship in Clinical Microbiology in the Department of Laboratory Medicine. Following her fellowship, she joined the Clinical Microbiology Service as a Staff Scientist where she co-directed the Bacteriology, Specimen Processing, Parasitology, and Molecular Epidemiology sections. In 2018, Dr. Lau was promoted to Chief of the newly created Sterility Testing Service to support the large NIH intramural cGMP program for aseptic processing and manufacturing of investigational new drugs for NIH clinical trials and Clinical Center patients.

    Dr. Lau's translational research involves advancing rapid testing platforms for cGMP microbiology using genomic and proteomic methods. She is an avid educator for clinical laboratories involved with product sterility testing and any form of cGMP microbiology. Her work is reflected in nearly 50 publications and book chapters and she has been recognized with numerous awards including eight NIH Clinical Center CEO and Director’s awards, and the Forbes 30 Under 30 Award for Healthcare Science. Dr. Lau also serves on the Editorial board for the Journal of Clinical Microbiology.

    The content of this event was developed independently from the AABB continuing education program. The opinions expressed are those of the faculty. Continuing education credit is not offered.

    Science & Innovation Forums are live and on-demand programs that are presented by companies serving the AABB community and target critical needs in the field that can be addressed by the sponsor’s solutions technology. Registration is complimentary to all.