eBook: mRNA — Negotiating New Manufacturing Hurdles

The emergency authorization, regulatory approval, and successful commercialization of Pfizer–BioNTech’s and Moderna’s respective mRNA vaccines for SARS-CoV-2 have ignited considerable interest in the modality across the biopharmaceutical industry — and for good reasons. Establishing a platform process for mRNA production could facilitate and accelerate several aspects of vaccine development and manufacturing. Drug makers also intend to leverage benefits associated with cell-free bioprocessing. But as the contributors to this eBook show, mRNA remains a nascent modality, and companies must surmount new hurdles stemming from increased demand for commercial-scale — and even pandemic-scale — manufacturing. In the eBook’s first chapter, Jake Adams of CRB explores what advantages can be reaped and what concerns remain for mRNA manufacturing. He calls particular attention to lingering questions for drug delivery and tissue targeting, especially considering the molecule’s inherent in vivo instability, as well as emerging difficulties relating to supply-chain constraints, contract manufacturing capacity, and transitions toward modular manufacturing models. Next, selections from recent BioProcess Insider articles highlight multiple companies’ efforts to disrupt current mRNA manufacturing networks with regional R&D facilities and production centers. Finally, BioProcess International’s senior technical editor explores mRNA’s distinct purification requirements and emerging strategies for addressing them. Read the eBook now to learn more about what biopharmaceutical developers and manufacturers will face up- and downstream as mRNA manufacturing takes hold in the industry.

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