As part of a long term growth strategy designed to meet increasing customer demands, CordenPharma has completed a recent key investment to strengthen development and manufacturing capabilities for API offerings across its Highly Potent & Oncology Platform. This new investment comes after the completion in early 2016 of a new CTD2 facility for the development and manufacturing of oral solid dosage Highly Potent & Oncology Drug Product compounds in its CordenPharma Plankstadt (Germany) facility, along with further expansion of capabilities in handling sterile Oncology Drug Products at CordenPharma Latina (Italy).
The new API process bay, now installed in CordenPharma Colorado (USA), is designed to handle a wide range of chemistries and unit operations with flexible and scalable components up to multi-kg batches. The facility builds on CordenPharma Colorado’s SafeBridge certified 30+ year legacy of safe and reliable production of highly potent APIs.
“With the operational qualification now complete, the first cGMP campaign is scheduled to be completed in early Q4 2016,” comments Brian McCudden, President & Managing Director of CordenPharma Colorado. This new addition complements the existing state-of-the-art infrastructure at CordenPharma Colorado, which is equipped to handle highly potent compounds up to OEB Level 5 spanning development to commercial-scale.