The minds behind the healthcare system have been striving to find a solution to any medical challenge that comes upon us. However, the entry of COVID has established the fact that we need a robust, collaborative, scalable, and agile digital healthcare infrastructure.
MALVERN, Pa., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases, today announced it has entered into an agreement with Kemwell Biopharma Pvt. Ltd. (Kemwell) to manufacture OCU200, Ocugen’s novel biologic product candidate in preclinical development for treating severely sight-threatening diseases like Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Wet Age-Related Macular Degeneration (Wet-AMD).
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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