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).
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 fisrt overcome some common roadblocks and navigate the complexities associated with business planning, technology, regulatory/risk assessment and engineering.
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