COLLECTION, STORAGE, & QUALITY ASSURANCE

收集、储存、

• 批准号: 2300002
• 负责人: MICHAEL HWANG
• 金额: $ 10万
• 依托单位: COVANCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-30 至 1996-09-08
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2300002
• 关键词: biological products; cell bank /registry; clone cells; evaluation /testing; monoclonal antibody; neoplastic cell; reagent /indicator

The contractor shall perform the following functions: Act as a repository for the storage and distribution of biological reagents and tumor cell lines, which are then made available to the scientific community. Assay microbiological agents to satisfy FDA requirements, in preparation for clinical trials. Conduct purification, modification, vialing, and testing of biologics obtained in bulk form for clinical use. Conduct general safety tests on biologics intended for clinical use. Produce GLP-grade monoclonal antibodies for preclinical evaluation and testing, as well as GMP-quality monoclonals.

承包商应执行以下功能： 充当生物学存储和分布的存储库 试剂和肿瘤细胞系，然后将其提供给 科学界。 测定微生物剂以满足FDA要求，以准备 用于临床试验。 进行生物制剂的纯化，修饰，瓶口和测试 以批量形式获得临床使用。 对旨在临床使用的生物制剂进行一般安全测试。 生产GLP级单克隆抗体用于临床前评估和 测试以及GMP质量的单克隆。