cGMP Manufacturing

cGMP Manufacturing

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.


We can offer the cGMP production services including:

 Cell banking services from cell line production to cryogenic storage.

 Fermentation batch/fed-batch and perfusion, up to 300L with a second 300L vessel.

 Single use/disposable systems supply you the higher quality and more flexible services.

 Downstream purification technologies including homogenization, continuous centrifugation, filtration systems and chromatography purification systems.

INQUIRY

  •   Email: info@profacgen.com
  •   Tel: 1-631-448-8149
  •   Fax: 1-631-938-8127
  •   45-1 Ramsey Road, Shirley, NY 11967, USA