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 validated equipment is designed by highly reputable suppliers, and the suites with full flexibility and quality are engineered by our team to achieve our shared objectives, and that ensures us a consistent and in-controlled operation.