News & Press
Speciality Chemicals Magazine, October / November 2018
CordenPharma has devoted 2018 to further expanding and strengthening its world-class service offerings organised under its five Technology Platforms by completing strategic key investment projects. It began the year by integrating its state-of-the-art manufacturing facility from Pfizer into its Highly Potent & Oncology platform. The facility, which was acquired at the end of 2017 (named CordenPharma Boulder) is close to the existing manufacturing facility, CordenPharma Colorado (US), and complements the company’s capabilities. With this set up, CordenPharma has become an industry leader and prime supplier in this segment, able to supply highly potent API quantities at any scale and potency, while meeting the most stringent industry standards as certified by consultancy SafeBridge®.
Highly Potent Drug Products
On the Drug Product side, CordenPharma also completed the construction of a non-GMP development facility at CordenPharma Plankstadt, near Heidelberg, Germany, for the development of highly potent oral solid dosage forms. The company is now uniquely positioned to provide development and manufacturing services at any stage and scale for highly potent and oncology products.
In addition, it is in the process of completing the final installation and qualification of a new manufacturing line dedicated to producing veterinary drug products at the Plankstadt facility. The line is intended to handle large-scale batch sizes (up to 500kg) to supply a complex innovation product for the veterinary and human health market. The expansion of production capabilities at the facility is the result of a new, long-term custom manufacturing agreement for an animal health application signed in 2017. Construction is expected to be completed by the end of the third quarter of 2018, with commercial supply for the global launch campaign planned to start in the first quarter of next year.
Investing in Italy
Finally, a €20 million (US$23.2) investment at CordenPharma Caponago in Italy, towards the construction of a new commercial aseptic fill and finish plant, is in the final stage of completion. The new facility, which comprises two highly flexible filling lines allowing the manufacture of a broad range of vials, pre-filled syringes and cartridges by using nest and tub technology, remains on track for completion this year. One of the new lines is already operational, with a successful PAI FDA inspection for two products, which will increase the manufacturing capacity up to two million vials/year, along with pre-filled syringes and additional lyophilisation capacity.