Streamlining Your Process Development Journey To GMP Manufacturing

By Miguel Valle, Scott Battist, Wilfredo Mateo, Christy Bigelow, Emergent

Moving a biopharmaceutical product from molecule to market is demanding in terms of the expertise and capabilities needed throughout the development and manufacturing process. Under pressure to reduce costs and capital investment, and to shorten development timelines while retaining access to the latest technologies, biopharma companies increasingly are outsourcing many or all specialist functions to contract development and manufacturing organizations (CDMOs).

In this article, we explore the processes and operations of Emergent CDMO, highlighting key characteristics that cultivate efficient organization alongside smooth and timely technology transfer and scale-up, from research and development (R&D) to Good Manufacturing Practice (GMP) manufacturing. A significant differentiator is that Emergent CDMO has an integrated, customer-focused approach that leverages its capacity and capabilities with the experience and product development expertise of a successful innovator company.