The investment, which is still being finalised, will be fully operational in Q2 2024 and authorised by German authorities in H2 2024.
The Frankfurt site will add 1000 sqm of manufacturing space, including two fully equipped lines comprising 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 I and II requirements.
As the project progresses along the customer lifecycle, the new state-of-the-art technologies will enable a smooth and seamless transfer to the late phase and commercial manufacturing site CordenPharma Colorado (Boulder, US).
Moreover, the GMP expansion supports the launch of an integrated service offering between CordenPharma Frankfurt (for Peptide Drug Substance) and CordenPharma Caponago (IT) (for Injectable Drug Products) to deliver fully customisable 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.
Through this integrated peptide-injectable offer, customers will benefit from
- one CDMO relationship with a single contract, including quality agreement and project management
- API route selection, salt and solubility studies, API characterisation, reference standard qualification
- formulation development, analytical method development and validation
- stability studies for development, toxicology and GMP batches
- technical writing for the IND/IMPD submission
The bespoke offer is tailored for each individual customer and will enable pharma and biotech innovators to move their complex modalities quickly to tox batch and FIH clinical trials, while actively managing business requirements and balancing timelines and budget, without losing track of important project milestones.
Dr Stéphane Varray, CordenPharma’s Global Peptide Platform Director, commented: "With our new early clinical GMP peptide manufacturing investment in Frankfurt and the launch of seamlessly integrated peptide API to injectable Drug Product services, CordenPharma is uniquely positioned to deliver customized CMC support for biotech customers and facilitate their successful IND/IMPD submissions and start of FIH clinical trials."
"We believe the offer will bring added-value and increased efficiency to our customers, and ultimately enhance the well-being of their patients.”