The Research Pharmacy provides a mechanism to develop, procure and validate the preparation and packaging of investigational drugs for clinical use.
Aims i nclude: - Development and validation of stability indicating assays - Verifying the accuracy of compounded medications - Determine the extended stability to improve medication shelf life - Validated packaging of medications where MSKCC holds the IND. Services include, but are not limited to, formulation analysis, selection of excipients, evaluation of release rates, prediction of interactions and determination of compatibility and stability of medications used in clinical practice. Specific equipment is available to package medications in capsules which is ideal for placebo controlled trials, as well as a Class 10,000 cleanroom for aseptic packaging of sterile injectables (vaccines, antibodies, small molecule injectables and opthalmics). The cleanroom is also helpful in reducing contamination in packaging of oral products which are prone to microbial growth - such as sugarbased formulations. This facility approaches cGMP standards and is fully compliant with the stipulations of USP 29 specifically chapters 795, 797, 1163 and 1075. All processes are thoroughly validated in accordance with all compendial standards. This facility also makes ample use of High Performance Liquid chromatography (HPLC) and is equipped with a Photodiode array for both UV and visible light and a fluorescence detector. This device has been used to validate the accuracy of all medications compounded within the facility. The fluorescence detector is useful to tract minute elutions from depot injection. The HPLC device has been used to determine extended stability of FDA approved drugs in clinical use here at MSKCC.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
3P30CA008748-47S4
Application #
8602871
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-01-20
Project End
2014-12-31
Budget Start
2012-01-09
Budget End
2012-12-31
Support Year
47
Fiscal Year
2013
Total Cost
$203,868
Indirect Cost
$96,343
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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