After process development, large scale fermentation or called cGMP manufacturing will be involved. Our scientific staff will transmit the process which is validated from the first Feasibility Study step to cGMP manufacturing staff and QC in a collaborative manner. The process development is the key for filing FDA IND CMC part. The manufacturing process will not be changed when clinical trials initiate.
Our state-of-the-art certificated facility is designed for multi-product operation and delivers a comprehensive range of services necessary to take novel biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply. From the very beginning to our shared target, our first class facility and professional capacity assure us of a smooth pipeline.
Our state-of-the-art certificated facility is designed for multi-product operation and delivers a comprehensive range of services necessary to take novel biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply. From the very beginning to our shared target, our first class facility and professional capacity assure us of a smooth pipeline.
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