cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). It is a system put in place to ensure the proper design, monitoring and control of manufacturing processes and facilities.
Our manufacturing facilities adhere strictly to GMP guidelines for each step of the manufacturing practice from initial development to final quality control (QC) release. This ensures we are able to deliver consistently high quality products.
Every batch meets USP <71> sterility & USP <85> Endotoxin testing standards of cGMP manufacturing.
Our research and development team will help you develop custom biosolutions formulation for your research or clinical application in your cell gene therapy, regenerative medicine, biobanking and drug discovery.