CMO Laboratory Expands GMP Manufacturing Capabilities
News Nov 25, 2010
“The addition of roller compaction expands our granulation capability, especially in the area of moisture sensitive and density-challenged API’s. When used in conjunction with our microdose capsule filling technology (Xcelodose 600S and Symyx Powdernium MTM2005), roller compaction also provides an option for larger fill weights in powder-in-capsule dosage forms,” said Kevin Rosenthal, Director of Manufacturing. “Additionally, with the purchase of two roller compactors we now have dry granulation capability in our highly-potent and non-highly-potent manufacturing facilities.”
Pharmatek has also complemented existing manufacturing capacities by expanding single-batch blending size capabilities three-fold (up to 36kg) with the acquisition of a 3 cu. ft. V-blender, and increasing capsule and tablet production by purchasing a Bosch GKF400 automated encapsulator with a rate of 23,000 capsules/hour and a Korsch PH-106 instrumented tablet press with rate of 32,400 tablets/hour.
“With the roller compactors, Pharmatek can now support a broad range of solid oral formulations that previously were not optimal or feasible using our existing wet granulation equipment due to moisture sensitivity. The 3 cu. ft. V-blender and Bosch encapsulator have positioned us well for large-scale Phase II clinical trial manufacturing,” stated Jeff Bibbs, CEO and CSO of Pharmatek. “Also, by expanding our existing encapsulation and tablet manufacturing capabilities, we can better serve our clients’ clinical drug supply needs as they move beyond small-scale development and transition to GMP manufacture of drug product for clinical trials.”