CLINICAL SUPPLY MANUFACTURING
PYRAMID’s Aseptic Sterile Clinical Manufacturing services include formulation, processing, and filling capabilities for Pre-clinical, stability studies, and Clinical for both vial and syringe applications for the Biotech and Pharmaceutical industries, for all regulatory phases.
- Clinical API’s for many clients are expensive. PYRAMID’s system and practices are designed to minimize losses, ensuring clients the highest maximum yield of finished product possible.
- PYRAMID’s new state-of-the-art, commercial scale manufacturing facility can accommodate the transfer and scale-up from Phase III Clinical to Commercial manufacturing.
- PYRAMID specializes in assisting with the development of processes and formulations for difficult products. Our capabilities include filling of various products with equipment designed for low volume aseptic fills. Product types range from simple solutions to more complicated delivery systems containing proteins, oligonucleotides, peptides, liposomes, etc.
- PYRAMID is highly specialized in developing and filling compounds that have low solubility
- Currently PYRAMID fills a wide range of vial sizes: 2 mL, 3 mL, 5 mL, 10 mL and 20 mL. The filling machine is capable of up to 250 mL bottles.
- Our syringe filling and stoppering system utilizes the Becton Dickinson Hypak™ system and our liquid processing capabilities range from volumes less than one liter to over one hundred liters at a variety of fill volumes.
- PYRAMID fills 0.5 mL, 1.0mL, 2.25 mL, and 3 mL syringes routinely. The filling system can accommodate 5 mL and 10 mL syringe configurations as well.
- The clinical freeze dryer can lyophilize batches up to 7,000 vials, depending on the vial size. Filling, loading and unloading of the clinical lyophilizer is done under Class 100 conditions in PYRAMID’s aseptic, clinical manufacturing facility.