A Side-by-Side Comparison of Clinical versus Current Good Manufacturing Practices (cGMP) Microbiology Laboratory Requirements for Sterility Testing of Cellular and Gene Therapy Products

Abstract

Over the last few years, there have been numerous discussions on the American Society for Microbiology’s clinical listservs (DivC, and ClinMicroNet) regarding sterility testing of cell and gene therapy products and environmental monitoring and gloved fingertip testing for hospital pharmacies. Clinical microbiology laboratories have often been asked to assist with testing due to the on-site proximity of laboratory equipment and microbiological expertise within the hospital environment. The role of the clinical microbiology laboratory in this setting, however, is questionable due to major differences in test requirements and regulatory oversight. Here, we provide a side-by-side comparison of clinical versus current good manufacturing practices microbiology laboratories to provide guidance to those that are currently assisting with or have been asked to assist with sterility testing of manufactured biopharmaceutical products that have become common frontline treatments in modern medicine.