10.17.16
CordenPharma has completed a new highly potent API process bay for category 4 compounds. 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 in the U.S., is designed to handle a wide range of chemistries and unit operations with flexible and scalable components up to multi-kg batches.
“With the operational qualification now complete, the first cGMP campaign is scheduled to be completed in early Q4 2016,” said Brian McCudden, president and managing director, 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.”
The new API process bay, now installed in CordenPharma Colorado in the U.S., is designed to handle a wide range of chemistries and unit operations with flexible and scalable components up to multi-kg batches.
“With the operational qualification now complete, the first cGMP campaign is scheduled to be completed in early Q4 2016,” said Brian McCudden, president and managing director, 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.”