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

基本信息

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
项目类别：
财政年份：
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

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

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项目摘要

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 Through our studies, we aim to improve the testing algorithm in the cGMP field, which is currently outdated, labor intensive, and subject to errors.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

在这个财政年度，我们发表了一个迷你审查，重点介绍了FDA/CGMP/制药行业的重要方面，该方面与目前对细胞疗法进行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制不同，这两个领域之间的实践和要求很大程度上对比。自2015年红色团队报告以来，我们利用我们的经验和专业知识，旨在弥合不育测试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就生物制药剂的微生物测试的要求进行教育，这随着治疗医学的进展正在增加。该研究项目的重点是评估各种测试平台，以在检测环境中的产品污染物时性能。通过我们的研究，我们旨在改善CGMP领域的测试算法，该算法目前已经过时，劳动密集并且会出现错误。我们2019年的研究强调了临床系统的局限性，以检测产品中的环境污染物，这使我们改变了实验室实践。在2020年，我们正在评估其他测试平台，以改善真菌检测，同时消除了对实验室文化处理的需求，以减少引入污染物的风险。