The expansion at the site near Milan will support customers to progress from pre-clinical and clinical development of xRNA-based therapeutics (mRNA, siRNA, saRNA, microRNA, & similar), enabling them to maximize and speed up the delivery of their drug products into clinical stages and beyond.
“CordenPharma’s capital investments will help introduce this advanced pharmaceutical manufacturing technology to Europe and support the creation of a highly resilient supply chain and robust next-generation operations,” says the Plankstadt, Germany headquartered company.
CordenPharma, a full-service CDMO of Active Pharmaceutical Ingredients (APIs), excipients, drug products & packaging services, is starting by expanding its R&D laboratory at the site with LNP formulation development and analytical characterization capabilities.
In addition to this, the expansion will integrate the sourcing of lipids from across the CordenPharma network, combining them seamlessly into the targeted genetic payload.
CordenPharma’s Caponago operations are set for expansion from late 2022 into early 2023 with the construction of a new hub for LNP formulation with cGMP manufacturing, where clinical batches at any stage, including small commercial drug products that adopt LNP technology, will be made. Up to 15 jobs will be created as a result of the expansion.
Fabio Stevanon, Global Injectable Platform Director of CordenPharma, said: "RNA-based therapies, including the more familiar mRNA products, are becoming more widely used, so the use of LNP is a particularly effective formulation approach for these products. CordenPharma is already recognised as a leading global source of synthetic lipids. As a result, this investment in LNP capability integrated into our fully-approved sterile Injectable site allows a “one-stop-shop” for our customers.”
CordenPharma’s LNP formulation technique utilizes two different LNP assembly technologies: Microfluidic and Jet-Impingement. Microfluidic technology controls the flow of two different solutions (water-based and lipid-based), then mixes them in a precise manner to deliver small, uniform particles capable of sterile formulation for proper introduction into the human body. The second technology that CordenPharma will be deploying is Jet-Impingement, via a modified T-Junction. This technology will be especially suited to accommodate larger-scale manufacturing.
This new LNP cGMP capability will be constructed alongside existing injectable formulation technologies, enabling CordenPharma to drive LNP-based drug formulations into liquid (vial or syringe) or lyophilized finished dosage forms.
In March, CordenPharma conducted its first positive tests of assembly and characterization of functional Lipid Nanoparticles by combining mRNA sourced from partner Wacker and Lipids internally sourced from CordenPharma sites (located in Switzerland and France) to produce a prototype formulation.
Along with its investment in LNP services, CordenPharma plans on expanding its drug product primary and secondary packaging capabilities at Caponago, adding highly automated, high-throughput filling and packaging lines to provide customers with new ways to dispense and deliver medications to patients. 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.