The company said the expansion, to take place from late 2022 into early 2023, is designed to support customers working on pre-clinical and clinical development of xRNA-based therapeutics – for example mRNA, siRNA, saRNA, microRNA or similar – and will enable them to maximize and speed up the delivery of their innovative drug products into clinical stages and beyond.

The new hub for LNP formulation is part of a move to build up a base for cGMP manufacturing in which the company can make clinical batches at any stage, including small commercial drug products that adopt LNP technology. Around 15 high-level jobs will be created in the process.

CordenPharma said the new LNP capability will be built alongside existing injectable formulation technologies, enabling it to easily drive LNP-based drug formulations into liquid (vial or syringe) or lyophilized finished dosage forms.

In March this year, the company conducted its first positive tests of assembly and characterization of functional lipid nanoparticles to produce a prototype formulation. To this end, it combined mRNA sourced from compatriot Wacker Chemie with lipids it produced in Switzerland and France. 

The latest investment will also help introduce the advanced pharmaceutical manufacturing technology to Europe and support the creation of a highly resilient supply chain and robust next-generation operations. In addition to formulation, the expansion will integrate the sourcing of lipids across the company’s network, combining them seamlessly into the targeted genetic payload, the CDMO said.

Along with microfluidic technology, CordenPharma will deploy Jet-Impingement via a modified T-Junction. This technology, it said, will be especially suited to accommodate larger-scale manufacturing.

Fabio Stevanon, global injectable platform director, called the investment in LNP formulation capabilities a “major step forward” for the company, not only boosting innovation in R&D, but also give it cutting-edge manufacturing techniques and complementing its position as a leader in synthetic lipids.

Along with investing in LNP services, the CDMO also plans to expand its drug product primary and secondary packaging capabilities at Caponago, adding highly automated, high-throughput filling and packaging lines. The additional capacity will focus on Pre-filled Syringes (PFS) and similar parenteral delivery technologies including unit-dose, and in the future, dose-injector devices.

CordenPharma is in the process of being acquired by private equity investor Astorg, which recently signed a binding agreement with current owner International Chemical Investors Group (ICIG). Details have not been announced, including when the deal is expected to close.

Author: Dede Williams, Freelance Journalist