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

用于细胞疗法和生物制药产品无菌检测的新型诊断平台

• 批准号: 10255210
• 负责人: Anna Lau
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10255210
• 关键词: Accountability; Algorithms; Biological Products; Cell Therapy; Clinical; Clinical Microbiology; Cyclic GMP; Dental Laboratories; Detection; Dialysis procedure; Drug Industry; Ensure; Environment; Environmental Monitoring; Environmental Pollution; Goals; Industry; Infusion procedures; Laboratories; Laboratory culture; Mainstreaming; Medicine; Methods; Microbiology; Mycoplasma; Patients; Performance; Pharmacy facility; Process; Publishing; Regulation; Reporting; Research Project Grants; Risk; Safety; System; Testing; Therapeutic; experience; improved; novel diagnostics; sterility testing; water testing

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 Through our studies, we aim to improve the testing algorithm in the cGMP field, which is currently outdated, labor intensive, and subject to errors.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

在本财年中，我们发布了一篇小型评论，重点介绍了 FDA/cGMP/制药行业与目前进行细胞疗法产品测试的临床实验室相关的重要方面。 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存在巨大差异。利用自 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学实验室之间的差距。我们的目标是教育我们的临床同事了解生物药剂微生物测试的要求，随着治疗医学的进步，对生物药剂的微生物测试的需求也在不断增加。该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，我们的目标是改进 cGMP 领域的测试算法，该算法目前已经过时、劳动密集型且容易出错。我们 2019 年的研究强调了临床系统检测产品中环境污染物的局限性，这促使我们改变了实验室实践。 2020 年，我们正在评估其他测试平台，以改进真菌检测，同时消除实验室培养物处理的需要，以降低引入污染物的风险。