In order to accommodate the continuous growth and evolution of the peptide therapeutic market, CordenPharma Colorado completed earlier this year an expansion of its Solid-Phase Peptide Synthesis manufacturing capacity with the addition of an extra-large 3000 L SPPS vessel. The company is anticipating expanding U.S. market needs by investing in new manufacturing techniques to improve the productivity of its peptide assets—in particular via the deployment of innovative Process Analytical Technology (PAT).
 
Now with even greater demand to rapidly respond to its partners’ accelerated programs, a long-term expansion initiative was approved to further increase flexibility, efficiency and ultimately, cost-effective production. For the first phase of this commitment, customized automated synthesizer production lines will be installed supporting fast and efficient GMP manufacturing. This infrastructure will further strengthen the existing manufacturing of Peptides in the low to mid-kg scale range by complementing the current state-of-the art large-scale manufacturing capabilities at CordenPharma Colorado.
 
In addition, special emphasis on design will further harmonize the network and enable a seamless Tech Transfer process from the Peptide Development Centre of Excellence in Frankfurt, Germany, due to an exact mirroring of its new non-GMP production lines that are currently being installed.
 
The new expansion initiative will be augmented by integrated supply of peptide APIs to Injectable Drug Products from CordenPharma Caponago, the company’s facility in Italy dedicated to the Formulation Development and Drug Product manufacturing of sterile injectables. By leveraging this global facility network, this vertical supply model spans the complete cGMP supply chain from regulated raw materials, intermediates, and APIs, to commercial-scale Drug Product manufacturing, finished dosage formulation, clinical trial services and pharma logistics.
 
GMP Peptide Manufacturing at CordenPharma Colorado (US)