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.
In this guidebook, our experts share some key considerations for designing, building and operating an agile and flexible GMP 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.
In 2011, we converted a stainless steel good manufacturing practice (GMP) bioproduction facility in Martillac, France into a state-of-the-art, fully single-use GMP facility, providing clients with increased speed to clinic. In this case study, we share with you some critical success factors and lessons learned.