CordenPharma is commissioning new GMP capacities at its Frankfurt site to manufacture early clinical phase peptide APIs for pharma and biotech customers. The investment is expected to be fully operational in 2Q24 and authorized by German authorities in 2H24. This follows an expansion of the Frankfurt site in 2020 for non-GMP manufacturing.
 
The Frankfurt site will add 1000 m² of manufacturing space, including two fully equipped lines comprised of a Solid Phase Peptide Synthesizer (SPPS), High Pressure Liquid Chromatography (HPLC), Liquid Phase (LP), isolation equipment and quality control laboratories including In Process Control (IPC), starting material batch release, and GMP stabilities. The GMP manufacturing area is designed to produce peptide APIs from gram to kilogram range for clinical phase 1 and 2 requirements. As the project progresses along the customer lifecycle, the new state-of-the-art technologies are designed to enable a smooth and seamless transfer to the late phase and commercial manufacturing site CordenPharma Colorado, in Boulder.
 
The GMP expansion supports the launch of an integrated service offering between CordenPharma Frankfurt (for Peptide Drug Substance) and CordenPharma Caponago (IT) (for Injectable Drug Products) to deliver customizable technical, manufacturing, and regulatory support specifically targeted to enable efficient IND / IMPD filings, with all the necessary materials needed to initiate customers’ First In-Human (FIH) clinical trials.
 
The integrated peptide-injectable offering includes: a single contract inclusive of quality agreement and project management; API route selection, salt and solubility studies, API characterization, reference standard qualification (RABS); formulation development, analytical method development and validation; and technical writing for the IND / IMPD submission.
 
Dr. Stéphane Varray, CordenPharma’s Global Peptide Platform Director, said, ‘With our new early clinical GMP peptide manufacturing investment in Frankfurt and the launch of seamlessly integrated peptide API to injectable Drug Product services, CordenPharma is uniquely positioned to deliver customized CMC support for biotech customers and facilitate their successful IND / IMPD submissions and start of FIH clinical trials. We believe the offer will bring added-value and increased efficiency to our customers, and ultimately enhance the well-being of their patients.”