Cambrex was approached by a top 20 US-based pharmaceutical company looking to partner with a contract manufacturing organization (CMO) with commercial manufacturing capabilities, large scale assets, multinational sites and exemplary quality systems/US FDA track record. The CMO would need to supply large volumes of an API in clinical phase III within a short timeline to pre-approval inspection (PAI). In order to meet the requirements of the project, the customer required more capacity to meet commercial supply needs.
With existing large scale assets, extensive commercial manufacturing expertise and excellent quality systems, Cambrex Charles City was chosen to build and validate a new facility following the customer’s framework, which included a 12-month timeframe followed by a PAI. Cambrex was also required to validate the facility, processes and procedures, begin production, hire and train employees and secure and release new materials.