Microbiology Lab in Cell Therapy Facility: Operational Aspects and Merits

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

Live Program Date: Thursday, May 11, 2017 - On-Demand Available

Master Program Number: 17EL-134 (see program format numbers below under Registration)

Educational Track: Technical/Clinical 
Topic: Cellular Therapies
Intended Audience: Scientists, Technologists, Managers/Supervisors, CEOs, CFOs, Laboratory Staff, Medical Directors
Teaching Level: Intermediate

Director/Moderator: Salem Akel, PhD, Scientific and Lab Director, Saint Louis Cord Blood Bank and Cell Therapy Laboratory at SSM Health Cardinal Glennon Children Medical Center, Saint Louis, MO
Speakers: Joan Lorenz, M(ASCP), Microbiology Technologist, St. Louis Cord Blood Bank, St. Louis, MO; Timothy Wood, BA, Microbiology Consultant, Cell Therapy Microbiology Consulting, LLC, Snoqualmie, WA

Learning Objectives

After participating in this educational activity, participants should be able to:
• Compare on-site microbiology lab model versus outside service model. 
• List major advantages and challenges associated with each model.
• Discuss lab setting and regulatory requirements, pertinent activities to cell therapy production, and responsibilities.

Program Description

Microbial studies and testing in cell therapy processing and/or banking facilities require different settings than clinical labs where specific activities expected to be performed such as validation studies of sterility test method for intended use, environmental microbial monitoring, disinfectants effectiveness studies, media fills to assure aseptic competency, etc.  The focus of this program will be to present operational options for cell therapy processing/banking facilities to cover relevant microbial activities taking into consideration two operational models: onsite lab model and outside service model.  Selection of appropriate model is governed by nature and size of work and availability of resources. Speakers will identify advantages and challenges related to each model and share their own experiences.


   Program #
Single Viewer: On-Demand Register17EL-4070-134
Group Viewing: On-Demand Register17EL-8070-134

Speaker Biographies

With previous work experience predominantly in clinical microbiology, including 20 years at SSM Cardinal Glennon Children’s Hospital, where sterility testing for St. Louis Cord Blood Bank (SLCBB) had been done since the bank was started, Joan Lorenz moved to SLCBB in 2011 initially to help validate an in-house sterility testing method and to conduct environmental monitoring of the facility in support of the bank’s biologics license application. Additional responsibilities now include various studies, culture media supply inventory/ lot release testing and media fill.

Timothy Wood has over 28 years' experience in Microbiology in cGMP industry. Tim is Principal Consultant at Cell Therapy Microbiology Consulting designed primarily for cellular therapies to develop and improving contamination controls, for example environmental monitoring programs and rapid or alternate sterility tests.  At Dendreon, Tim helped to get the prostate cancer cellular immunotherapy PROVENGE through clinical trials, FDA approval, and launched to commercial cGMP immunotherapy manufacturing facilities.  Tim developed the BacT/Alert in-house sterility test for PROVENGE improving method specificity and decreasing detection time.  Tim has worked as a Microbiologist at companies including ICOS, Xcyte Therapies, CellPro, and Abbott Laboratories.  Tim received his Bachelor's degree in Biology from Pacific Lutheran University, Tacoma, WA.