Case Study

Speed To Market – API Large Scale Commercial Manufacturing

Source: Cambrex
iStock-136140244-lab-pharma-equipment-process

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.

VIEW THE CASE STUDY!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Drug Discovery Online? Subscribe today.

Subscribe to Drug Discovery Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Drug Discovery Online