Research Pharmacy

摘要

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.