By Dr. S. Ribault, G. Plane, M. Richard, and J. Pionchon
A guidebook for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. One of these decisions includes defining the commercial manufacturing strategy for their biopharmaceutical and whether it makes business sense to build their own good manufacturing practice (cGMP) biomanufacturing facility or outsource to a contract manufacturing organization (CMO).
MilliporeSigma has gained significant expertise throughout the design, build and ongoing operations of the Biodevelopment Center in Martillac, France that could prove invaluable to companies that are considering whether to build their own cGMP facility. Today, the facility in Martillac houses a total of five state-of-the-art cGMP suites (three upstream, two downstream) for therapeutic protein production. This facility is one of the first to attain cGMP compliance utilizing single-use equipment for each unit operation from upstream through downstream. The facility was also designed to lower its environmental impact, including a significant decrease in water usage.
In this guidebook, our experts share some key considerations for designing, building and operating an agile and flexible cGMP biomanufacturing facility successfully, safely, and profitably. To achieve this goal, companies must first overcome some common roadblocks and navigate the complexities associated with business planning, technology, regulatory/risk assessment and engineering.