News

CordenPharma Expands Early Clinical Peptide Manufacturing in Germany

07.03.2024 - CordenPharma has commissioned new GMP capacities at its site in Frankfurt, Germany to manufacture early clinical phase peptide APIs for pharma and biotech customers. The investment, which is still being finalized, is scheduled to be fully operational in the second quarter of 2024 and authorized by German authorities in the second half of 2024.

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, later enabling seamless transfer to late-stage and commercial production at the company’s US site in Boulder, Colorado, CordenPharma said.

According to CordenPharma, the GMP expansion also supports the launch of an integrated service offering between the sites in Frankfurt (for peptide drug substance) and Caponago in Italy (for injectable drug products) to deliver fully customizable technical, manufacturing, and regulatory support that is specifically targeted to enable efficient IND/IMPD filings, with all the necessary materials needed to initiate customers’ first in-human (FIH) clinical trials.

Contact

Corden Pharma International

Aeschenvorstadt 71
4051 Basel
Switzerland