CordenPharma announces completion of new highly potent API process bay for category 4 compounds

Published: 20-Oct-2016

CordenPharma is considered to be the CDMO partner of choice for the pharma industry when it comes to the development and manufacture of highly potent and oncology compounds, meeting the most stringent requirements from major global health authorities and customers

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 and oncology platform.

This new investment comes after the completion in early 2016 of a new CTD2 facility for the handling (development/manufacturing) of oral solid dosage drug product manufacturing of highly potent and oncology 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 and 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.

'With this new investment, CordenPharma is uniquely positioned to provide pharma customers with the most comprehensive highly potent and oncology service in the industry spanning the entire API and drug product supply chain at any stage from development to commercialisation,' adds Dr Michael Quirmbach, Vice President of Global Sales and Marketing, CordenPharma International.

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