Speed to Market: API Large-Scale Commercial Manufacturing

Case study
Drug substance

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 (condensed to 10 months) to pre-approval inspection (PAI). In order to meet the requirements of the project, the customer required more capacity to meet commercial supply needs, which meant building and validating a brand-new facility following the customer’s framework and hiring and training new employees to begin production within the shortened timeframe.

To learn how Cambrex was able to deliver for our client, download the full case study.