CordenPharma Expands Clinical Peptide Capacity

CordenPharma announced on March 6, 2024 that it is expanding capacity at its Frankfurt, Germany site to accommodate the manufacture of early clinical-phase peptide APIs for its pharmaceutical and biotech customers. The company is planning for the expansion to be operational in the second quarter of 2024 with authorization by German authorities completed in the second half of 2024.

As part of the expansion, 1000 square meters of manufacturing space will be added to the Frankfurt site. The site will add two fully equipped lines comprised of a solid phase peptide synthesizer, high-pressure liquid chromatography, liquid phase isolation equipment, and quality control laboratories. The quality control labs will feature in-process control, starting material batch release, and good manufacturing practice (GMP) stabilities. The GMP manufacturing area will produce peptide APIs from gram to kilogram range for clinical Phase I and Phase II requirements with later transfer to the company’s late-phase and commercial manufacturing Boulder, Colo., site in the United States.

The GMP expansion will support the launch of the integrated services between the company’s CordenPharma Frankfurt site and CordenPharma Caponago, which offers services for injectable drug products. The integrated peptide-injectable services will be tailored to the individual customer and will deliver technical, manufacturing, and regulatory support for investigational new drug (IND)/investigational medicinal product dossier (IMPD) filings and first-in-human (FIH) clinical trials. Customers will benefit from working with one contract development manufacturing organization with a single contract, quality agreement, and project management. The offering also features API route selection, salt and solubility studies, API characterization, and reference standard qualification. Formulation development, analytical method development, and validation will also be provided. Assistance with technical writing for IND/IMPD submissions will also be available.

"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 [chemistry, manufacturing, and controls] 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,” said Stéphane Varray, CordenPharma’s Global Peptide Platform director, in a press release.

The company previously expanded the Frankfurt site in 2020 to include an increase in available lab space by 25% and the addition of a dedicated explosion proof area.

In 2021, the company invested €9.7 million (US$10.9 million) into the design and installment of a new clinical trial development facility for manufacturing oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.

In February 2024, the company also launched its new Lipid NanoParticle (LNP) Starter Kits for the formulation of messenger RNA (mRNA)-based therapeutics, such as mRNA vaccines or gene therapies. The starter kits are designed to provide researchers and developers with the essential components needed to create and optimize their own LNPs for mRNA delivery. The kits allow users to fine-tune the LNP formulation process and achieve production of nanoparticles with the desired physicochemical characteristics, such as polydispersity index ≤0.2 and a size range between 30–150 nm, depending on specific LNP reaction conditions, lipid composition, and cargo used.

Source: CordenPharma