Post by Rentschler Biopharma
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At a recent ISPE DACH event in Ravensburg, Germany, our colleague Melanie Jawerka, Senior Director MSAT, shared her expertise and insights into a critical phase in biopharmaceutical project execution: moving client projects from development into commercial manufacturing. In her presentation “Process Implementation of client projects from development to commercial”, Melanie explored what the “change to commercial” means in practice – the transition from a fixed process design and successful development to validated, full-scale production and market availability. Melanie brought the topic to life with three Rentschler Biopharma case studies – from scaling up production to meet rapidly increasing demand to stabilizing a historically grown legacy process through structured change management. This is a strong example of how our MSAT experts combine scientific depth, regulatory understanding and hands-on manufacturing experience to support clients from development to commercial success. Thank you to ISPE DACH and Vetter Pharma for hosting this valuable exchange. #RentschlerBiopharma #CDMO #ReliabilityYouCanTrust