Research Pharmacy

摘要 研究药房(RP)核心提供全面的服务设施，准备由MSK开发的代理 在临床前或临床研究中用作研究药物的研究人员。核心由三个部分组成 主要群体：用于药物制剂/稳定性和制剂的药品生产设施； 临床级生产(CGP)设施，用于大宗产品的制造、纯化和装瓶；以及 药房调查药物服务(PIDS)，提供开发、采购、准备和 验证临床使用的研究药物的制备、包装和分配。核心服务 包括但不限于药物释放速率配方、分析和评估；预测 相互作用；以及药物的配伍和物理稳定性的测定。由于 作为核心的基础设施，MSK已经能够将多种不同类型的 药理制剂，包括传统的小分子药物、放射性药物和疫苗。 PPF/CGP/PIDS联合小组提供的广泛服务和协作工作 RP核心已经支持了来自12个部门的33名研究人员在37项IRB批准的方案中的研究。 该中心的工作已在主要的普通兴趣或癌症杂志上发表了34篇文章。为 例如，治疗性抗体3F8仅在MSK被提纯、制造和瓶装；这 治疗性抗体构成了该中心神经母细胞瘤研究计划的支柱；现在 已被证实是治疗儿童难治性神经母细胞瘤的有效方法。该中心很大，而且 复杂的疫苗计划，将碳水化合物和多肽疫苗整合在复杂的KLH主干上或在 具有新佐剂的混合物也依赖于三方RP的服务来支持临床 针对浆液性卵巢癌、白血病、间皮瘤和肉瘤等癌症的疫苗测试。

ABSTRACT The Research Pharmacy (RP) Core provides a full service facility that prepares agents developed by MSK researchers to be used as investigational drugs in preclinical or clinical studies. The Core comprises three principal groups: the Pharmaceutical Product Facility (PPF) for drug formulation/stability and preparation; the Clinical Grade Production (CGP) Facility for bulk product manufacturing, purification, and vialing; and the Pharmacy Investigational Drug Service (PIDS), which provides a service to develop, procure, prepare, and validate the preparation, packaging, and distribution of investigational drugs for clinical use. The Core services include, but are not limited to, formulation, analysis, and evaluation of drug release rates; prediction of interactions; and determinations of compatibility and physical stability of medications. Owing to the infrastructure of the Core, MSK has been able to bring into early phase clinical trials multiple distinct types of pharmacologic agents, including traditional small molecules, radiopharmaceuticals, and vaccines. The broad range of services and collaborative work provided by the combined PPF/CGP/PIDS groups within the RP Core has supported the research of 33 investigators from 12 Department in 37 IRB-approved protocols. The work of the Core has contributed to 34 publications in leading general interest or cancer journals. For example, the therapeutic antibody 3F8 is purified, manufactured, and vialed exclusively at MSK; this therapeutic antibody forms the backbone of the Center’s research program in neuroblastoma; and has now been validated as an effective treatment for children with refractory neuroblastoma. The Center’s 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.