Build Vs. Outsource: Considerations For Drug Development & Manufacturing

By Regina Choi-Rivera

The decision whether to handle drug development and manufacturing in-house or to outsource to a CDMO partner comprises numerous elements. Costs, timelines, production capacity, and available resources (equipment, facilities, and personnel) all must be considered. The resulting benefit-vs.-risk equation is complex, since every sponsor, drug, and situation is different. In some cases, it is advantageous to acquire and/or build resources in-house, while others call for partnership with a CDMO with expertise in process development and manufacturing.

In a recent webinar, “Build vs. Buy: When to Outsource Biologics Development and Manufacturing,” Regina Choi-Rivera, General Manager at AGC Biologics’ mammalian facility in Boulder, CO, discussed how limited knowledge, experience, and resources can stymie an organization’s efforts to develop or expand in-house development and manufacturing. She also explored the benefits of tapping into a CDMO’s diverse knowledge, experience, and resources to accelerate development and manufacturing while reducing risk and, often, costs.

Following the webinar, Choi-Rivera responded to audience questions about build vs. buy in general, as well as AGC Biologics’ newest facilities and initiatives in the future.