Research Pharmacy

研究药房

• 批准号: 10571817
• 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/10571817
• 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; Good Manufacturing Process; Infrastructure; Institutional Review Boards; Investigational Drugs; Journals; Keyhole Limpet Hemocyanin; Laboratory Finding; Malignant Neoplasms; Malignant neoplasm of ovary; Manufacturer; Mesothelioma; Neuroblastoma; Outsourcing; Patients; Peptide Vaccines; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy facility; Phase; 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; manufacture; monoclonal antibody 3F8; novel; operation; pharmacologic; 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.

抽象的 研究药房 (RP) 核心提供全套服务设施，可制备 MSK 斯隆开发的药物 研究人员在临床前或临床研究中用作研究药物。核心包括三个 主要小组：用于药物配方/稳定性和制备的药品设施（PPF）；这 用于散装产品制造、纯化和装瓶的临床级生产 (CGP) 设施；和 药房研究药物服务 (PIDS)，提供开发、采购、准备和 验证用于临床的研究药物的制备、包装和分发。核心服务 包括但不限于药物释放速率的配制、分析和评估；的预测 互动；以及药物的相容性和物理稳定性的测定。由于 凭借核心基础设施，MSK 斯隆已经能够将多种不同类型的药物带入早期临床试验。 药物制剂，包括传统的小分子、放射性药物和疫苗。 由 PPF/CGP/PIDS 联合小组提供的广泛服务和协作工作 RP 核心支持来自 12 个部门的 33 名研究人员在 37 个 IRB 批准的方案中进行的研究。 核心的工作已在领先的大众兴趣或癌症期刊上发表了 34 篇出版物。为了 例如，治疗性抗体 3F8 专门由 MSK 纯化、制造和装瓶；这 治疗性抗体构成了该中心神经母细胞瘤研究项目的支柱；现在已经 已被证实是治疗难治性神经母细胞瘤儿童的有效方法。该中心规模宏大， 复杂的疫苗计划，将碳水化合物和肽疫苗整合到复杂的 KLH 骨架上或 与新型佐剂的混合物也依赖于三方RP的服务来支持临床 测试针对癌症的疫苗，包括浆液性卵巢癌、白血病、间皮瘤和肉瘤。