Research Pharmacy

研究药房

• 批准号: 10084829
• 负责人: Raymond J Muller
• 金额: $ 21.38万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-20 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10084829
• 关键词: Adjuvant; Biological Assay; Cancer Center Support Grant; Carbohydrates; Child; Clinical; Clinical Research; Complex; Development; Dosage Forms; Drug Evaluation; Drug Formulations; Ensure; Formulation; Health Services Research; Infrastructure; Institutional Review Boards; Investigation; Investigational Drugs; Journals; Keyhole Limpet Hemocyanin; Laboratory Finding; Malignant Neoplasms; Malignant neoplasm of ovary; Manufacturer Name; Mesothelioma; Neuroblastoma; Outsourcing; Patients; Peptide Vaccines; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Pharmacy facility; Phase I Clinical Trials; Phase II Clinical Trials; Preparation; Production; Protocols documentation; Publications; Radiopharmaceuticals; Reagent; Refractory; Research; Research Personnel; Research Support; Resources; Safety; Serous; Services; Sterility; Subgroup; Therapeutic Agents; Therapeutic antibodies; Time; Translational Research; Translations; Vaccines; Vertebral column; Vial device; Work; cancer therapy; clinical application; cost; design; dosage; drug development; drug release kinetics; early phase clinical trial; effective therapy; improved; innovation; interest; leukemia; monoclonal antibody 3F8; novel; operation; phase I trial; preclinical study; programs; research clinical testing; sarcoma; skills; small molecule; vaccine evaluation

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.

摘要 研究药房（RP）核心提供了一个全面的服务设施，准备由MSK开发的代理 研究者将其用作临床前或临床研究中的试验药物。核心包括三个 主要小组：药品生产设施（PPF），负责药物配制/稳定性和制备; 用于散装产品生产、纯化和装瓶的临床级生产（CGP）设施;以及 药房研究药物服务（PIDS），提供开发、采购、制备和 验证临床使用的研究药物的制备、包装和分发。核心服务 包括但不限于药物释放速率配制、分析和评价; 相互作用;以及确定药物的相容性和物理稳定性。由于 作为核心的基础设施，MSK已经能够将多种不同类型的 药物制剂，包括传统的小分子、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 Core支持了来自12个部门的33名研究人员在37个IRB批准的方案中的研究。 核心的工作为34篇主要的一般性兴趣或癌症期刊的出版物做出了贡献。为 例如，治疗性抗体3F 8仅在MSK纯化、制造和装瓶;这 治疗性抗体是该中心神经母细胞瘤研究项目的支柱;目前已 已被证实是治疗儿童难治性神经母细胞瘤的有效方法。该中心的大， 复合疫苗计划，将碳水化合物和肽疫苗整合在复合KLH骨架上或 与新型佐剂的混合物也依赖于三方RP的服务，以支持临床 针对包括浆液性卵巢癌、白血病、间皮瘤和肉瘤在内的癌症的疫苗测试。