Trends in outsourcing of CMC development services for biologics

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, BioPhorum Development Group conducted a survey on outsourcing approaches for sponsor and contract development and manufacturing organization members.

Through well-executed outsourcing, a sound partnership between Sponsor and contract (development) and manufacturing organization (C(D)MO) is beneficial in many ways. Value is realized in the reduction of the time to market, the acquisition of enhanced knowledge, access to novel technologies, increased capacity and through the conservation of Sponsor resources. With some effort and focus, favourable development and manufacturing relationships can evolve, prosper and endure for long-term mutual benefit.

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. From such discussions, participants decided to codify processes, learning and experiences by polling members for their outsourcing practices. 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. BioPhorum considered that these findings will be useful to a broader audience because it is the complexity of manufacture of biopharmaceutical products that leads to proportionately complex relationships in sourcing arrangements. Survey design, results and interpretation of responses are presented and discussed, including identification of best practices and recommendations from participating companies.