CordenPharma expands early-phase peptides

CordenPharma has announced the commissioning of new GMP capacities at its Frankfurt site to manufacture early clinical phase peptide APIs. The investment is still being finalised, but will be fully operational in Q2 and authorised by German authorities in 2H.

The company will add 1,000 m2 of manufacturing space, including two fully equipped lines comprised of a solid phase peptide synthesiser, high pressure liquid chromatography, liquid phase, isolation equipment and QC labs. This will produce peptide APIs from gram to kilogram range for Phases I and for transfer to the late-phase and commercial site in Colorado.

The expansion also supports the launch of an integrated service offering between Frankfurt for peptide drug substance and the Caponago site in Italy for injectable drug products. With this offer, said global peptide platform director Dr Stéphane Varray, “CordenPharma is uniquely positioned to deliver customized CMC support for biotech customers and facilitate their successful IND/IMPD submissions and start of first-in-human clinical trials.”