Novel Diagnostic Platforms for Sterility Testing of Cellular Therapies and Biopharmaceutical Products

点击翻译按钮获取中文摘要

During this fiscal year, we published a mini-review highlighting important aspects of the FDA/cGMP/pharmaceutical industry that are relevant to clinical labs currently performing product testing for cellular therapies. Regulatory accountability differs between cGMP and clinical laboratories, and practices and requirements vastly contrast between these two fields. Using our experience and expertise since the Red Team report in 2015, we aim to bridge the gap between sterility testing requirements and the clinical microbiology lab. Our goal is to educate our clinical colleagues on the requirements for microbiological testing of biopharmaceutical agents which is increasing in demand with advances in therapeutic medicine. This research project focuses on evaluating various testing platforms for their performance in detecting product contaminants from the environment. Through our studies, we aim to improve the testing algorithm in the cGMP field, which is currently outdated, labor intensive, and subject to errors. Our 2019 study highlighted limitations of clinical systems to detect environmental contaminants in products which led us to change laboratory practices. In 2020, we are evaluating additional testing platforms to improve fungal detection whilst removing the need for laboratory culture handling to reduce risk of introducing contaminants.