Kemwell is a contract biologics development and CMO company providing services to global biologics organizations. Kemwell facilities, located in Bangalore, India, are designed and developed with technological support from a leading German pharma company. Kemwell provides customers with cost-effective access to state-of-the-art technology for all mammalian cell culture based products’ development and manufacturing.
Risk assessment on Environmental monitoring: a CDMO perspective
Over the past decade, environmental monitoring (EM) program has become a critical factor, refined, moving from random sampling to testing each imaginary grid in the cleanrooms of aseptic cGMP manufacturing sites.
Kemwell experience in successful scale-ups for mammalian cell-culture processes to large scale clinical or commercial mfg
Scale-up of a cell culture process is seldom straightforward, more so when scaling up for the first time in a new facility. The recipe for a successful scale-up includes a thorough understanding of the cell culture process, manufacturability of the process at scale, well-characterized bioreactors and efficient utilization of the available scale-up principles.
Kemwell Biopharma Selected to Manufacture the Monoclonal Antibody Drug Substance For a US Phase 3 Clinical Trial
Kemwell Biopharma, a biologics contract development and manufacturing service provider, announced today that it has signed a contract to manufacture and supply drug substance using its state-of-the-art mammalian cell culture plant in India for Phase 3 clinical trials that will be conducted in the US by its customer for a BLA filing.
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