Research Pharmacy

研究药房

• 批准号: 8933548
• 负责人: Raymond J Muller
• 金额: $ 20.64万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8933548
• 关键词: Adjuvant; Cancer Center Support Grant; Carbohydrates; Chemistry; Child; Clinical; Clinical Trials; Complex; Consultations; Drug Formulations; Human; Institutional Review Boards; Instruction; Investigation; Investigational Drugs; Keyhole Limpet Hemocyanin; Label; Laboratories; Malignant Neoplasms; Malignant neoplasm of ovary; Memorial Sloan-Kettering Cancer Center; Mesothelioma; Neuroblastoma; Peptide Vaccines; Pharmacologic Substance; Pharmacy facility; Preparation; Production; Protocols documentation; Publications; Radiopharmaceuticals; Research; Research Infrastructure; Research Personnel; Research Support; Serous; Services; Testing; Therapeutic antibodies; Vaccines; Vertebral column; Work; base; effective therapy; leukemia; monoclonal antibody 3F8; novel; pre-clinical; programs; research clinical testing; sarcoma; small molecule; sterility testing

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.

研究药学核心（RP）是必不可少的MSKCC的翻译工作。核心支持 MSKCC将其科学发现从实验室研究推进到临床研究的能力 概念验证测试。RP有三个主要组成部分：1）药品设施 (PPF)用于药物制剂/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;以及3）药学研究药物服务（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、配制、装瓶、贴标、稳定性/无菌性 测试和分配。RP与研究产品核心携手合作， 每个MSKCC IND的化学、生产和控制部分。通过RP，MSKCC可以 将内部想法推进到早期的人体测试中。由于RP的基础设施，MSKCC一直 能够将多种不同类型的药理学试剂引入早期临床试验。其中包括传统 小分子放射性药物和疫苗核心小组提供的服务支持了 在过去的一年里，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， 核心小组的工作为5个方案的25份出版物做出了贡献。例如，治疗性抗体 3F 8是在MSKCC专门纯化、生产和装瓶的，构成了研究的支柱。 神经母细胞瘤的研究它现在已被证实是一种有效的治疗儿童与 神经母细胞瘤大而复杂的疫苗计划，整合了碳水化合物和肽 复合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试验，包括浆液性卵巢癌， 白血病间皮瘤和肉瘤