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: 10684569
• 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/10684569
• 关键词: Adopted; Agar; Awareness; Biological Products; Book Chapters; Cell Therapy; Cells; Clinical; Clinical Microbiology; Cyclic GMP; Dental Laboratories; Detection; Dialysis procedure; Ensure; Environmental Monitoring; Event; Glucose; Goals; Human; Industry; Infusion procedures; Instruction; Laboratories; Methods; Microbiology; Mycoplasma; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy facility; Publishing; Safety; Side; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; Sterility; System; Testing; The science of Mycology; Tissues; United States National Institutes of Health; base; biopharmaceutical industry; clinical application; design; diagnostic platform; falls; gene therapy; improved; novel diagnostics; novel therapeutics; sterility testing; water testing

During this fiscal year, we published the first study to evaluate the performance of iLYM media as a closed-system, automated alternative for Sabouraud Dextrose Agar culture for improved detection of fungal contaminants for cell and gene therapy sterility testing. This study impacts the biopharmaceutical industry significantly, as test methods for sterility testing are outdated, designed for sterile bulk pharmaceuticals, and are generally unsuitable for cell and gene therapy products. In addition, we published a side-by-side comparison of cGMP vs clinical microbiology labs in an effort to educate clinical colleagues participating in human cells, tissues, and cellular and tissue-based products (HCT/Ps). We have also published several book chapters for microbiological instruction and guidance for cell and gene therapy testing and continue to actively publish on MALDI-TOF MS applications for clinical mycology.

在本财政年度，我们发表了第一项研究，以评估iLYM培养基作为沙氏葡萄糖琼脂培养的封闭系统自动化替代品的性能，以改善细胞和基因治疗无菌试验中真菌污染物的检测。这项研究对生物制药行业产生了重大影响，因为无菌测试的测试方法已经过时，专为无菌原料药设计，通常不适用于细胞和基因治疗产品。此外，我们发表了cGMP与临床微生物学实验室的并排比较，以教育参与人体细胞，组织以及细胞和组织产品（HCT/Ps）的临床同事。我们还出版了几本关于细胞和基因治疗测试的微生物学指导和指南的书籍章节，并继续积极出版临床真菌学的MALDI-TOF MS应用。