DCP - Biopharmaceutical Development Program (BDP) Support

DCP - 生物制药开发计划 (BDP) 支持

• 批准号: 10819456
• 负责人: LEONARD FREEDMAN
• 金额: $ 43.4万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-31 至 2023-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10819456
• 关键词: Area; Biological Products; Cell Culture Techniques; Cell Therapy; Clinical; Clinical Trials; Contractor; Development; Good Manufacturing Process; Guidelines; Immunoconjugates; Industry; Investigational Drugs; Mission; Monoclonal Antibodies; Peptides; Pharmacologic Substance; Phase; Phase I Clinical Trials; Phase III Clinical Trials; Program Development; Recombinant Proteins; Regulation; Research Personnel; Sterility; Testing; United States Food and Drug Administration; Vial device; Virus; Work; manufacture; plasmid DNA; vector vaccine

The Contractor shall operate a Biopharmaceutical Development Program (BDP), currently a contractor-operated facility in contractor-leased space established by the NCI to develop and produce clinical-grade biopharmaceuticals, including but not limited to: monoclonal antibodies, recombinant proteins, immunoconjugates, peptide and DNA plasmid vaccines, viruses, cell therapies, and other biologicals. The BDP also provides biopharmaceutical development expertise in the areas of cell culture, purification, characterization, analysis, vialing, and Food and Drug Administration (FDA) regulatory compliance. Although the mission of the BDP in support of the NCI and other entities, as requested through NCI, is to manufacture small to medium scale quantities of clinical-grade biopharmaceuticals under current Good Manufacturing Practices (cGMPs) for use in Phase I and II clinical trials, in exceptional circumstances NCI may also require the use of this facility to conduct similar work for synthetic pharmaceuticals (e.g., sterile filling for i.v. solutions). The BDP shall comply with U.S. FDA regulations and guidelines as is appropriate to meet compliance level requirements for each product manufactured. Products intended for use in Exploratory IND clinical trials shall be manufactured and tested in accordance with the FDA’s guideline, “Guidance for Industry, Investigators, and Reviewers – Exploratory IND Studies.” Products intended for Phase I clinical trials are manufactured in accordance with the guideline, “Guidance for Industry – cGMP for Phase I Investigational Drugs.” Products intended for Phase II and non-pivotal Phase III clinical trials shall be manufactured following those aspects of 21 CFR 211 that apply to investigational use products.

承包商应实施生物制药开发计划（BDP），目前由NCI在承包商租赁的空间内建立的承包商运营设施，用于开发和生产临床级生物制药，包括但不限于：单克隆抗体、重组蛋白、免疫缀合物、肽和DNA质粒疫苗、病毒、细胞疗法和其他生物制剂。BDP还在细胞培养、纯化、表征、分析、装瓶和美国食品和药物管理局（FDA）监管合规性领域提供生物制药开发专业知识。虽然发展局支持NCI和其他实体的使命是根据NCI的要求，根据现行的良好生产规范（cGMP）生产小到中等规模的临床级生物药品，用于I期和II期临床试验，但在特殊情况下，NCI也可能需要使用该设施进行合成药品的类似工作（例如，用于静脉注射溶液的无菌填充）。BDP应符合美国FDA法规和指南，以满足所生产的每种产品的合规性水平要求。预期用于探索性IND临床试验的产品应根据FDA指南“行业、研究者和审评人员指南-探索性IND研究”进行生产和检测。预期用于I期临床试验的产品是根据指导原则“行业指南-I期研究药物的cGMP”生产的。预期用于II期和非关键III期临床试验的产品应按照21 CFR 211中适用于研究用产品的方面进行生产。