PRODUCTION, PROCESSING & QUALITY ASSURANCE OF TSI

生产、加工

• 批准号: 3701165
• 负责人: MICHAEL HWANG
• 金额: $ 8万
• 依托单位: TSI WASHINGTON LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-06-01 至 2001-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3701165
• 关键词: biological response modifiers; cryopreservation; drug design /synthesis /production; drug quality /standard; drug screening /evaluation; immunoconjugates; monoclonal antibody; vaccines

The Biological Response Modifiers Program (BRMP) has the responsibility for preclinical and early clinical evaluation and development of a wide variety of biological response modifiers (BRMs) with potential for cancer therapy. An important aspect of this responsibility is the procurement, processing and quality assurance testing of various GLP and GMP BRMs for preclinical and clinical investigations. The purpose of this contract will be to provide effective management of these functions for the BRMP. The Contractor will be responsible for the production, processing and quality assurance testing of biologic agents. Quality assurance and control testing involves specific assays for sterility, pyrogenicity, endotoxin levels, general safety testing and preclinical studies related to the development of a safe dose and route of administration. The Contractor will also be responsible for purification, vialing, labeling, potency and purity testing of biologics obtained in bulk form for laboratory or clinical use. In some instances, production or conjugation of biologics, such as monoclonal antibodies or vaccines for preclinical laboratory use or clinical trials will also be performed. All procedures will conform to the Food and Drug Administration specifications for the development of biologics and will be in compliance with Government regulations for human use products. The Contractor will also be responsible for assisting with the development of master drug files and investigational new drug (IND) applications on biologics produced by the Contractor for the NCI.

生物响应修饰符计划（BRMP）有责任 用于临床前和早期临床评估和开发 具有癌症潜力的生物反应修饰符（BRMS） 治疗。 这项责任的一个重要方面是采购， 各种GLP和GMP BRM的处理和质量保证测试 临床前和临床研究。 本合同的目的 将为BRMP提供有效管理这些功能。 承包商将负责生产，加工和 生物学剂的质量保证测试。 质量保证和 控制测试涉及对无菌性，热源性， 内毒素水平，一般安全测试和临床前研究 开发安全剂量和行政途径。这 承包商还将负责净化，瓶，标签， 以批量形式获得的生物制剂的效力和纯度测试 实验室或临床用途。 在某些情况下，生产或共轭 临床前的生物制剂，例如单克隆抗体或疫苗 还将进行实验室使用或临床试验。 所有程序 将符合食品和药物管理局的规格 生物制剂的发展，并将符合政府 人类使用产品的规定。 承包商也将是 负责协助开发主毒品文件和 研究性新药（IND）对生物制剂的应用 NCI的承包商。