Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics – monoclonal antibody, bi-specific or multi-specific antibodies, fusion proteins, etc. The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical manufacturing or even cGMP commercial manufacturing.
Quality Control and Quality Assurance
Kemwell team has extensive audit handling experience and capabilities. The facilities are audited by reputed global multinational clients, European QPs, former USFDA inspectors and regulatory agencies. A USFDA Pre-Approval Inspection (PAI) for a BLA filing is expected by 2020.
Stability Studies
Kemwell provides complete stability storage and testing standalone services for biologics in all recommended ICH conditions as well as custom temperature, humidity conditions. We can work with your protocol or develop one for you and conduct stability studies at various stages of the product life cycle: development through commercial batches