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.