CordenPharma Expands xRNA-Based Capabilities with Strategic Investment in LNP Formulation Services at its Caponago Injectable Facility

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CordenPharma, a full-service contract manufacturing development organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, pharmaceuticals and packaging services, has increased its RNA x capabilities at its plant sterile injectables in Caponago, Italy.

The company announces that it is investing more than 10 million euros in new areas of formulation, development and production of lipid nanoparticles (LNPs).

The expansion will help customers transition from preclinical and clinical development of xRNA (mRNA, siRNA, sRNA, microRNA and similar) therapies, enabling them to maximize and accelerate the delivery of their innovative pharmaceuticals to clinical stages and beyond.

The initial phase has now begun with CordenPharma expanding its R&D laboratory with LNP formulation development and analytical characterization capabilities at its CordenPharma Caponago sterile injectables facility.

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.

In addition to the LNP formulation, the expansion will integrate lipid supply within 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.

The construction will create up to 15 high-level jobs, which CordenPharma expects to recruit and fill over the next few months.

Fabio Stevanon, Global Head of Injectable Platform, CordenPharma, said, “Our planned investment in LNP formulation capabilities is a major step forward for CordenPharma. This will not only drive innovation in R&D, but also give us state-of-the-art manufacturing for the benefit of our customers.

“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 easily transform LNP-based drug formulations into liquid (vial or syringe) or lyophilized finished dosage forms. CordenPharma Caponago (IT) LNP R&D Laboratory: TFF equipment for diafiltration and concentration of lipid nanoparticle formulations.

In March 2022, 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.

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