The expansion of the site near Milan will help customers transition from preclinical to clinical development of xRNA-based therapies (mRNA, siRNA, sRNA, microRNA, etc.), enabling them to maximize and accelerate the delivery of their pharmaceuticals in clinical stages and beyond.
“CordenPharma’s capital investments will help bring this advanced pharmaceutical manufacturing technology to Europe and support the creation of a highly resilient supply chain and robust next-generation operations,”says the company based in Plankstadt, Germany.
CordenPharma, a full-service CDMO of active pharmaceutical ingredients (APIs), excipients, pharmaceuticals and packaging services, is beginning to expand its on-site R&D lab with LNP formulation development capabilities and analytical characterization.
On top of that, the expansion will integrate the sourcing of lipids through the CordenPharma network, seamlessly combining them into the targeted genetic payload.
CordenPharma’s Caponago operations are expected to expand from late 2022 to early 2023 with the construction of a new center for LNP formulation with cGMP manufacturing, where clinical batches at any stage, including small commercial drugs that adopt LNP technology, will be manufactured. Up to 15 jobs will be created as a result of the expansion.
Fabio Stevanon, Global Head of Injectable Platform at CordenPharma, said: “RNA-based therapies, including the more familiar mRNA products, are increasingly used, so the use of LNP is a particularly effective formulation approach for these products. CordenPharma is already recognized as one of the world’s leading sources of synthetic lipids.As a result, this investment in LNP capability integrated into our fully approved sterile injectables facility provides our customers with the benefit of a ‘one stop shop’.
CordenPharma’s LNP formulation technique uses two different LNP assembly technologies: Microfluidic and Jet-Impingement. Microfluidic technology controls the flow of two different solutions (water-based and lipid-based), then precisely mixes them to deliver small, uniform particles capable of sterile formulation for proper introduction into the human body. The second technology CordenPharma will deploy is Jet-Impingement, via a modified T-junction. This technology will be particularly suitable to adapt to larger-scale manufacturing.
This new cGMP LNP capability will be built alongside existing injectable formulation technologies, allowing CordenPharma to process LNP-based drug formulations into liquid (vial or syringe) or lyophilized finished dosage forms.
In March, CordenPharma conducted its first positive tests for the assembly and characterization of functional lipid nanoparticles by combining mRNA from partner Wacker and lipids sourced internally from CordenPharma sites (located in Switzerland and France) to produce a prototype formulation.
Along with its investment in LNP services, CordenPharma plans to expand its primary and secondary pharmaceutical 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. Additional capacity will focus on pre-filled syringes (PFS) and similar parenteral delivery technologies, including unit dose devices and, in the future, dose injection devices.