FULL cGMP MANUFACTURE
At our Reading site we offer full cGMP manufacturing to support phase 1 and phase 2 clinical trials
Our state of the art GMP facility houses two dedicated laboratory cleanrooms (ISO-8, equivalent to class 100,000) for manufacture of material for phase 1 and phase 2 clinical trials. Equipped with reactors up to 50 L, operating from -90oC to +200oC, we can produce batch sizes from grams to kilograms. As your project evolves, we can facilitate the transfer of processes to other sites within the ICE group for late-stage clinical trial manufacture.
cGMP manufacture is supported by a full analytical capability
Including method development, qualification and validation as well as degradation and stability studies, specification development and full QC testing of all incoming raw materials and intermediates. Our analytical facilities are well resourced with qualified equipment providing support to all phases of our projects.