Investing in Capacity: API Commercial Manufacturing

Case study
Drug substance

Cambrex was approached by a top 10 Asian pharmaceutical company looking to partner with a contract manufacturing organization (CMO) with commercial manufacturing capabilities and expertise, mid- to large-scale cGMP assets and exemplary quality systems and US FDA track record. The requirement was to find a cost-effective process to produce the API for a new drug.

Cambrex worked with the emerging company that initially developed the drug, so proactively, we approached the customer with innovative ideas for a new cost-effective method. The original chemistry included a high number of chemical and purification steps, and Cambrex believed a more efficient method was achievable.

Read the full case study to learn how our scale-up and commercial production expertise allowed us to deliver the client’s required volume of API in time at the target cost whilst working in collaboration with the team to meet the safety requirements.