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 Through our studies, we aim to improve the testing algorithm in the cGMP field, which is currently outdated, labor intensive, and subject to errors.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，我们发表了一篇小型综述，重点介绍了FDA/cGMP/制药行业与目前正在进行细胞疗法产品测试的临床实验室相关的重要方面。监管责任在cGMP和临床实验室之间是不同的，实践和要求在这两个领域之间存在巨大的反差。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和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对生物药剂的微生物测试的要求，这是随着治疗医学的进步而增加的需求。这项研究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，目前cGMP领域的测试算法过时、劳动强度大、容易出错。我们2019年的研究强调了临床系统在检测产品中的环境污染物方面的局限性，这导致我们改变了实验室做法。在2020年，我们正在评估更多的测试平台，以改进真菌检测，同时消除对实验室培养处理的需要，以降低引入污染物的风险。