DCP - Biopharmaceutical Development Program (BDP) Support

承包商应运营生物药物开发计划(BDP)，该计划目前是承包商在NCI建立的承包商租赁空间内运营的设施，用于开发和生产临床级生物药物，包括但不限于：单抗、重组蛋白、免疫结合物、多肽和DNA质粒疫苗、病毒、细胞疗法和其他生物药物。BDP还在细胞培养、纯化、表征、分析、瓶装和食品和药物管理局(FDA)法规遵从性方面提供生物制药开发专业知识。根据NCI的要求，BDP支持NCI和其他实体的任务是根据当前的良好制造规范(CGMP)生产中小规模的临床级生物药物，用于第一阶段和第二阶段临床试验，但在特殊情况下，NCI也可能要求使用该设施来进行合成药物的类似工作(例如，静脉注射的无菌灌装。解决方案)。BDP应符合美国FDA的法规和指南，以满足所制造的每个产品的合规性级别要求。用于探索性IND临床试验的产品应按照FDA的指南“工业、研究人员和审查者指南-探索性IND研究”进行生产和测试。拟用于第一阶段临床试验的产品是根据指南“行业指南-第一阶段研究药物的cGMP”生产的。用于第二阶段和非关键第三阶段临床试验的产品应按照21 CFR 211中适用于研究用途产品的那些方面进行制造。

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.