Product & Cycle Development:
PYRAMID’s goal in the development of a lyophilized drug product is to produce a pharmaceutically elegant and physico-chemically stable product that can be easily reconstituted and administered to the patient. Scientists at PYRAMID have the background and knowledge in lyophilization technology to assist you in reaching that goal for your drug product.
PYRAMID has the laboratory equipment, differential scanning calorimeter and laboratory-scale lyophilizers, to aid in the development of optimal formulations and lyophilization cycles for your drug product. Experience has shown that the cycles developed on our laboratory-scale units scale-up well to our clinical manufacturing lyophilizer, a 30 sq. ft. shelf area unit.
Depending on the vial size, the clinical freeze dryer can lyophilize batches up to 7,000 vials. Of course, filling, loading and unloading of the clinical lyophilizer is done under Class 100 conditions in PYRAMID’s aseptic, clinical manufacturing facility.
PYRAMID’s commercial, aseptic manufacturing facility has a much larger 213 sq. ft., Telstar lyophilizer that can accommodate up to 37,500 vials that are 5 mL or 10 mL in size. This lyophilizer has both CIP and SIP capabilities, is connected to a back-up power supply and is equipped with redundant critical operational components (coolant compressors, circulation pumps and vacuum pumps) to minimize the risk of breakdown during a freeze drying cycle. Vials to be lyophilized are washed, depyrogenated/sterilized, filled and stoppered on our IMA high speed, vial line located in our commercial, aseptic manufacturing facility.