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

在本财政年度，我们发布了一份小型综述，重点介绍了FDA/cGMP/制药行业的重要方面，这些方面与目前进行细胞疗法产品测试的临床实验室相关。cGMP和临床实验室之间的监管责任不同，这两个领域的实践和要求也有很大的不同。利用我们自2015年红队报告以来的经验和专业知识，我们的目标是弥合无菌检测要求与临床微生物实验室之间的差距。我们的目标是教育我们的临床同事对生物制剂的微生物学测试的要求，随着治疗医学的进步，生物制剂的微生物学测试的需求正在增加。本研究项目的重点是评估各种测试平台在检测环境中产品污染物方面的性能。通过我们的研究，我们的目的是改进目前cGMP领域的检测算法，该算法过时，劳动密集，容易出错。我们2019年的研究强调了临床系统在检测产品中环境污染物方面的局限性，这导致我们改变了实验室实践。2020年，我们将评估额外的测试平台，以改善真菌检测，同时消除实验室培养处理的需要，以降低引入污染物的风险。

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 Through our studies, we aim to improve the testing algorithm in the cGMP field, which is currently outdated, labor intensive, and subject to errors.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.