BIOLOGICAL RESPONSE MODIFIERS

生物反应调节剂

• 批准号: 3614835
• 负责人: JOAN C RENER
• 金额: $ 3.9万
• 依托单位: COVANCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-10 至 1992-09-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3614835
• 关键词: biological products

The purpose of this contract is to provide effective management of these functions for the BRMP. The contractor shall be responsible for receipt, dispensing, storage, distribution and inventory control of biologic agents. Quality assurance and control evaluation which involves specific assays for sterility, pyrogenicity, endotoxin levels, general safety testing and preclinical studies related to safe dose and route of administration. The contractor shall be responsible for processing, vialing, labelling, potency and purity testing of biologics obtained in bulk form for clinical use. In some instances production and initial purification of biologics, such as monoclonal antibodies for clinical trails is performed.

该合同的目的是提供有效的管理 BRMP的功能。 承包商应负责收据， 生物学剂的分配，存储，分配和库存控制。 质量保证和控制评估，涉及特定的测定 无菌性，热源性，内毒素水平，一般安全测试和 临床前研究与安全剂量和给药途径有关。 这 承包商应负责处理，瓶，标签，效力 以及以批量形式获得的生物制剂的纯度测试，以供临床使用。 在 某些实例生产和生物制剂的初始纯化，例如 进行临床径径的单克隆抗体。