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.
Process Development
Kemwell provides extensive mammalian cell culture-based products’ development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology transfers, and process characterization. Moreover, our scientists have demonstrated the capability to design and execute development work to meet defined product quality attributes.
Formulation Development
Kemwell offers formulation development services for early and late stage clinical development and commercial products based on target formulation profiles. Formulation development work is carried out collaboratively with analytical development groups to ensure that robust and stability indicating analytical methods are used appropriately during formulation development. Accelerated and real-time stability studies, and varieties of stress stability are employed to deliver the best formulation for your product.
Analytical Development
Kemwell offers analytical services for mammalian cell culture-based products to support your clinical and commercial product needs. Our efficient and strong Analytical Development team is unified into R&D services.