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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA008748-54
Application #
9858290
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2020-01-01
Budget End
2020-12-31
Support Year
54
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Sloan-Kettering Institute for Cancer Research
Department
Type
DUNS #
064931884
City
New York
State
NY
Country
United States
Zip Code
10065
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