Further GMP expansion in peptides for CordenPharma
CordenPharma has announced the approval of a long-term expansion initiative “to further increase our flexibility, efficiency and ultimately, cost-effective production” at its solid-phase peptide synthesis (SPPS) in Boulder, Colorado. This follows the installation of an extra-large 3,000L SPPS vessel at the site earlier this year in response to growing demand for peptide APIs.
The facility, which was formerly owned by Roche, already has a 10,000-litres SPPS vessel and a 100 cm high-pressure reverse phase purification column. It is claimed to have the largest capacity of any peptide API facility, as well as being able to produce peptide APIs from laboratory-scale to commercialisation at tonne-scale.
In the first phase of the new expansion, customised automated synthesiser production lines will be installed to support GMP manufacture in the low to mid-kg scale range. The company added that “special emphasis on design will further harmonise our network and enable a seamless tech transfer” process from its centre of excellence for peptide process development and non-GMP manufacturing at Frankfurt, Germany.
CordenPharma had earlier announced an unspecified investment at this site to increase lab space by 25% and add a dedicated explosionproof area, supported by a tank farm, which “will allow for the introduction of regular solvents, as well as compatibility with our green peptide manufacturing”. This should be complete in Q3 2021.