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.
The Research Pharmacy provides services and expertise associated with the preparation, analysis and dispersion of investigational drugs. The Core is essential to the translational work at the Center and serves as a key conduit to deliver research discoveries from Center investigators to clinicians for human proof-of-concept testing.
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