DCP - Biopharmaceutical Development Program (BDP) Support

承包商应运营一个生物制药开发项目（BDP），该项目目前是由NCI在承包商租赁的空间内建立的由承包商运营的设施，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、免疫偶联物、肽和DNA质粒疫苗、病毒、细胞疗法和其他生物制品。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）法规遵从等领域提供生物制药开发专业知识。虽然BDP的任务是支持NCI和其他实体，根据NCI的要求，按照现行的《药品生产质量管理规范》（cgmp）生产用于I期和II期临床试验的小到中等规模的临床级生物药品，但在特殊情况下，NCI也可能要求使用该设施进行合成药物的类似工作（例如，静脉注射溶液的无菌灌装）。BDP应符合美国FDA法规和指导方针，以满足每个生产产品的合规要求。用于探索性IND临床试验的产品应按照FDA的指南“行业、研究者和审稿人指南-探索性IND研究”进行生产和测试。用于I期临床试验的产品按照指南“工业指南- I期研究药物的cGMP”生产。用于II期和非关键III期临床试验的产品应按照适用于研究用产品的21 CFR 211的那些方面生产。

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.