Research Pharmacy

研究药学核心 (RP) 对于 MSKCC 的转化工作至关重要。核心支持 MSKCC 将其科学发现从基于实验室的研究推进到基于临床的能力 概念验证测试。 RP 具有三个主要组成部分： 1) 药品设施 (PPF) 用于药物配方/稳定性和相容性问题； 2) 临床级生产 (CGP) 设施 用于散装产品纯化和装瓶； 3) 药房研究药物服务处 (PIDS) 支持临床前和临床使用的研究药物的制备和包装。 RP工作人员 提供咨询、散装产品分析和纯化、配方、装瓶、标签、稳定性/无菌 测试和分配。 RP 与研究产品核心携手合作，准备 每个 MSKCC IND 的化学、制造和控制部分。通过 RP，MSKCC 可以 将内部想法推进到早期人体测试中。由于 RP 的基础设施，MSKCC 已 能够将多种不同类型的药物纳入早期临床试验。这些包括传统的 小分子、放射性药物和疫苗。核心提供的服务支持了 去年，来自 5 个项目和 49 个 IRB 方案的 24 名研究者进行了研究。自上次审查以来， 核心的工作已为 5 个计划的 25 份出版物做出了贡献。例如，治疗性抗体 3F8 是在 MSKCC 独家纯化、制造和装瓶的，构成了研究的支柱 神经母细胞瘤计划。目前已被证实可以有效治疗儿童 神经母细胞瘤。庞大而复杂的疫苗计划，整合了碳水化合物和肽 基于复杂 KLH 骨架或与新型佐剂混合的疫苗也依赖于 三方 RP 支持癌症疫苗的临床测试，包括浆液性卵巢癌、 白血病、间皮瘤和肉瘤。

The Research Pharmacy Core (RP) is essential to the translational work of MSKCC. The Core supports the ability of MSKCC to advance its scientific discoveries from laboratory-based investigations to clinical-based Proof-of-Concept testing. The RP has three principal components: 1) The Pharmaceutical Product Facility (PPF) for drug formulation/stability and compatibility issues; 2) The Clinical Grade Production (CGP) Facility for bulk product purification and vialing; and 3) the Pharmacy Investigational Drug Service (PIDS) which supports the preparation and packaging of Investigational drugs for preclinical and clinical use. The RP staff provide consultation, bulk product analysis and purification, formulation, vialing, labeling, stability/sterility testing, and dispensing. The RP works hand-in-hand with the Investigational Products Core to prepare the Chemistry, Manufacturing, and Control Section for each of MSKCC's IND's. Through the RP, MSKCC can advance internal ideas into early human testing. Owing to the infrastructure of the RP, MSKCC has been able to bring multiple distinct types of pharmacologic agents into early clinical trials. These include traditional small molecules, radiopharmaceuticals, and vaccines. The services provided by the core have supported the research of 24 investigators from 5 Programs and 49 IRB protocols in the last year. Since the last review, the work of the Core has contributed to 25 publications from 5 Programs. For example, the therapeutic antibody 3F8 is purified, manufactured, and vialed exclusively at MSKCC and forms the backbone of the research program in neuroblastoma. It has now been validated as an effective treatment for children with neuroblastoma. The large and complex vaccine program, integrating both carbohydrate and peptide vaccines on complex KLH backbone or in mixtures with novel adjuvants is also dependent on the services of the tripartite RP to support the clinical testing of vaccines against cancers Including serous ovarian cancer, leukemia, mesothelioma, and sarcoma.