CORE--BIOLOGICAL PRODUCTION RESOURCE

核心--生物生产资源

• 批准号: 7339060
• 负责人: Ronald L. Manger
• 金额: $ 26.79万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-01 至 2007-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7339060
• 关键词: Antibodies; Biological; Cultured Cells; Human; Methods; Monoclonal Antibodies; Production; Purpose; Quality Control; Range; Request for Applications; Research; Research Peer Review; Research Personnel; Resource Sharing; Resources; Role; Standards of Weights and Measures; Therapeutic; United States Food and Drug Administration; cost; intravenous administration; milligram

The purpose of the Biologics Production Shared Resource is fourfold: (1) to develop and optimize production of biologic agents in the most cost-effective manner possiblel (2) to optimize methods of purification of biologic agents at high yield; (3) to develop, evaluate and maintain quality control standards for biologic agents intended for intravenous administration in humans and (4) to provide investigators with monoclonal antibodies and other therapeutics in both quantity and form suitable for intravenous administration in humans. Resource activities focus on production and purification of purified antibodies and other cell culture derived products in amounts ranging from milligrams to grams with concomitant support to meet both research and U.S. Food and Drug Administration (FDA) requirements. This application requests continued support for a resource which continues to fulfill an essential role for peer reviewed research within the Consortium.

生物制剂生产共享资源的目的有四个：(1) 以最具成本效益的方式开发和优化生物制剂的生产；(2) 优化高产率生物制剂的纯化方法； (3) 制定、评估和维护用于人类静脉内给药的生物制剂的质量控制标准，以及 (4) 为研究人员提供适合人类静脉内给药的数量和形式的单克隆抗体和其他治疗药物。资源活动侧重于纯化抗体和其他细胞培养衍生产品的生产和纯化，数量从毫克到克不等，并提供相应支持以满足研究和美国食品和药物管理局 (FDA) 的要求。该申请要求继续支持资源，该资源继续在联盟内的同行评审研究中发挥重要作用。