With our new mRNA Research Services offer you can come to us with just the protein that you want to encode as mRNA.
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.
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.
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.
Learn moreOur 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.
Partnering with an experienced CDMO provides access to specialized expertise, established platforms, and scalable infrastructure designed to support mRNA programs end-to-end. Our comprehensive mRNA services utilize an integrated approach to accelerate development timelines, mitigate technical risks, and support a smooth transition from early-stage research to global commercial supply.
We recommend engaging as early as possible, ideally during the discovery or early development phase. By involving our LNP mRNA service experts early on, we can design processes with long-term scalability and manufacturability built-in, reducing downstream risks and accelerating your path to clinic.
Yes. We provide full lifecycle support for mRNA programs, spanning from initial discovery and process development to clinical supply and commercial manufacturing. Our integrated mRNA services enables continuity, efficient technology transfer, and consistent quality across every stage of your molecule’s journey.
Key considerations include deep technical expertise in mRNA and LNP, integrated end-to-end capabilities, proven scalability, and extensive regulatory experience. Lonza combines these strengths with a global track record in LNP services to support reliable program progression and successful market entry.
Developing mRNA and LNP processes together improves compatibility, supports product performance, and reduces development risk. Our integrated LNP mRNA service approach optimizes drug substance and drug product as a single system, supporting faster timelines and tighter control of critical quality attributes.
