CordenPharma International is investing to provide expanded offerings across multiple technology platforms and facilities. Dr. Stephen Houldsworth, Senior Vice President, Global Head of Platform Management & Marketing, CordenPharma International, outlined the company’s expansion plans at the DCAT Week 2024 Member Company Announcement Forum held on March 18th, 2024, at DCAT Week. 

GMP Peptide 2024 Expansion–CordenPharma Frankfurt. After an initial expansion in 2020, the company has commissioned new GMP capacities at its site in Frankfurt, Germany, to manufacture peptide APIs in the gram-to-kilogram range for clinical Phase I & II requirements. The new area will include an additional 1000 m² of manufacturing space with two fully equipped lines comprised of a solid-phase peptide synthesizer (SPPS), high-pressure liquid chromatography (HPLC), liquid-phase reactors, and isolation equipment / quality control laboratories with IPC, starting-materials batch release and GMP stabilities.The investment will be fully operational in the second quarter of 2024 and will allow transfer of peptide APIs to the company’s late-phase commercial manufacturing site, CordenPharma Colorado, in Boulder, Colorado.

Integrated Peptide–Injectable IND-Targeted Integrated Offering. The GMP peptide expansion also supports the launch of an integrated offering between CordenPharma Frankfurt for peptide APIs and CordenPharma Caponago in Italy for injectable drug products. This offering provides customizable technical, manufacturing, and regulatory support specifically targeted to enable efficient investigational new drug (IND) / investigational medicinal product dossier (IMPD) filings and includes all the necessary materials needed to initiate first in-human clinical trials.

Oral Solid Dose 2024 Expansion–CordenPharma Plankstadt. The company also is launching new capabilities in its Drug Product Innovation Center of Excellence focusing on bioavailability-enhancement technologies for oral solid dose development and manufacturing. Integrated across multiple technology platforms in collaboration with the Solid State Center of Excellence (Liestal, Switzerland), the expansion includes developability assessment for API profiling and technology selection, screening studies, small-scale prototype development, and predictive software for advancing into clinical trials quickly (right first time).

In addition, the company’s new GMP expansion for clinical trial materials (5-60 kg batch sizes) includes encapsulation of direct API, powders, granules, pellets, and mini-tablets into capsules. This incorporates new tablet, hot-melt extrusion, and spray-drying technologies, organic-solvent capabilities, highly-potent containment down to < 0.1 µg/m³, and a flexible facility design to allow multiple projects to be run in parallel.

LNP Formulation 2024 Expansion–CordenPharma Caponago (Italy). The company also announced the commissioning of a new 900-m² GMP lipid nanoparticle (LNP) manufacturing facility in 2024. It features integrated LNP supply across multiple platforms to allow simplified and faster supply in all phases of xRNA-based, oligo-based, and gene-therapy drug-product development and manufacturing.The investment includes a facility with an ATEX room for safe handling of organic solvents, along with multiple LNP assembly and purification technologies. It additionally complements the company’s existing LNP development capabilities introduced in 2022, which perform formulation, process, analytical and purification development activities.