Research Pharmacy Core

Overview of Services

The Research Pharmacy provides a mechanism to develop, procure and validate the preparation and packaging of investigational drugs for clinical use. Services provided 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 are ideal for placebo controlled trials. The Research Pharmacy works in conjunction with the Clinical Grade Facility which has 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 sugar based formulation. This facility approaches cGMP standards and is full compliant with the stipulations of USP specifically chapters 795, 797, and 1163. All processes are thoroughly validated in accordance with all compendial standards. This facility also makes ample use of High Performance Liquid chromatography (HPLC). This device 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 here. 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 Memorial Sloan-Kettering Cancer Center.

Scientific aims include:

• 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 Memorial Sloan-Kettering holds the IND.

Leadership

Mark G. Klang, MS, RPh, BCNSP, PhD 

Core Head

212.639.7574

klangm@mskcc.org

Location and hours of operation

Contacts