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.
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, 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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