CordenPharma erweitert Peptidherstellung in Frankfurt
CordenPharma hat an seinem Standort in Frankfurt neue GMP-Kapazitäten in Betrieb genommen, um Peptidwirkstoffe in der frühen klinischen Phase für Pharma- und Biotechkunden herzustellen. Die Investition, die sich noch in der Abschlussphase befindet, soll im zweiten Quartal 2024 vollständig in Betrieb genommen und von den deutschen Behörden in der zweiten Jahreshälfte 2024 genehmigt werden.
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.
