An end-to-end offering: From pre-clinical to clinical development through to commercialization

Once you have nominated your lead compound for development, we support you with CMC activities throughout the full lifecycle of your lead candidate. Our end-to-end CMC services enable you to focus on your core activities in non-clinical and clinical development, while we deliver the required material with the essential quality.

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Utilize our experts to resolve your challenges

Manufacturing a successful mRNA formulation requires seamless integration of multiple elements. It requires a smart choice and a reliable sourcing strategy for the DNA template, a stable and efficient mRNA in vitro transcription process with a smart capping approach, a stable encapsulation of mRNA in lipid nanoparticles (LNP), as well as a reliable partner for the sterile filling of vials. Lonza has the capabilities to bring all these processes together with extensive experience in managing complex manufacturing set-ups and supply chains. We provide this for mRNA/LNP manufacturing in one network at cGMP quality.

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New Offering

Next generation encapsulation of nucleic acids with FDmiX

FDmiX, which was developed by FDX Fluid Dynamix and Fraunhofer IPK, utilizes a unique oscillating flow. This technology results not only in considerable process advantages (e.g. fast processing times) but also in high stability and homogeneity of LNPs, while maintaining favorable Critical Quality Attributes.

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Our location

Geleen – new mRNA/LNP services and manufacturing

At our site in Geleen, Lonza operates cell and gene therapy process development and manufacturing, mRNA/LNP process and analytical development labs, as well as clinical cGMP capabilities. The facility includes more than 30,000 square feet of laboratory, cGMP manufacturing and office space. The expansion supports the manufacturing of non-GMP product suitable for formulation development and toxicology studies, as well as cGMP product for early and late-stage clinical trials. The expanded development services at the Geleen (NL) site are available with cGMP readiness scheduled in the first quarter 2024.

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