The addition was completed at the company’s Boulder, Colorado facility, which is equipped to handle highly potent compounds up to OEB Level 5 spanning development to commercial-scale.
With the new process bay, the facility can now handle a range of chemistries and unit operations with flexible and scalable components up to multi-kg batches.
According to Brian McCudden, President and Managing Director of CordenPharma Colorado, the first cGMP campaign is scheduled to be completed in early Q4 2016.
The investment comes on the heels of several facility improvements, including expanded development capabilities (CTD2) at its Plankstadt (Germany) facility, and further expansion of capabilities in handling sterile oncology drug products at CordenPharma Latina (Italy).