Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it is the first CRO on the West Coast to acquire the Xcelodose system, enhancing the company's preclinical and early phase clinical GMP supply capabilities.
"Pharmatek is always looking for ways to move our customers' drug candidates into the clinic more efficiently without compromising quality," said Jeffrey Bibbs, Ph.D., Chief Scientific Officer of Pharmatek Laboratories. "For powder-in-capsule (PIC) applications, the Xcelodose can drastically decrease time to clinic while also lowering the cost of drug product for first-in-human trials."
The Xcelodose, manufactured by Capsugel, a division of Pfizer, is a precision powder micro-doser and automated encapsulator that has the ability to fill formulations or active pharmaceutical ingredient (API) directly into capsules with a remarkable level of accuracy. The Xcelodose can measure to levels as low as 100 micrograms and can dispense into capsules from size 00 to 4. Dosing directly into capsules can reduce the amount of API required. Additionally, the unit reduces overall development time by simplifying analytical and stability protocols.
Pharmatek Laboratories will install the Xcelodose unit in its solid dose manufacturing facility located in San Diego, California. The unit is expected to be validated by mid-October 2009. The company is currently scheduling Xcelodose manufacturing productions for November and December, 2009.