Many companies have increasingly sought to outsource chemistry, manufacturing, and controls (CMC) development services. Successful outsourcing has many benefits, such as meeting increased demand, reducing the time to market and improving capacity.

However, BioPhorum has found that many companies approach outsourcing differently. To better understand best practices for decision making, governance and management, the group conducted a survey on outsourcing approaches for sponsor and contract development and manufacturing organization members. The results have been published in the paper Trends in Outsourcing of CMC Development Services for Biologics.

“The paper offers a complementary perspective of two different viewpoints from the sponsor and the contractor manufacturer,” said Andrew Kim, Associate Director, Downstream MSAT at Samsung Biologics. “That is something you don’t see very often in the literature. That to me is something that stands out and differentiates it from other papers.”

Trends in outsourcing of CMC development services for biologics

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Release Date - 28th January 2021

  CMC     contract manufacturer     Sponsor/CMO data standards  

Abstract

The interplay, engagement and interactions between Sponsor and C(D)MO are frequently considered, presented and discussed at the BioPhorum Development Group, a gathering of more than 20 global biopharmaceutical companies, representing both Sponsor and C(D)MO organizations, with a focus on chemistry, manufacturing and controls (CMC)-related clinical biopharmaceutical development, testing and manufacture. This self-survey was aimed at understanding outsourcing approaches and governance and focused on analytical development and testing, process development and manufacturing, project management and governance and quality system and regulatory support. From the aggregate survey responses in each area, key trends were identified, providing insights to potential best practices