mRNA Manufacturing

One commercial mRNA drug substance manufactured by Lonza

We have successfully supported the launch of an mRNA revolution and are ready to support many others.

30+ Years' of Experience

We have extensive cGMP experience in most modalities including mRNA.

100+ qualified suppliers worldwide

We have an established network of qualified suppliers who provide components for GMP manufacturing, including key raw materials and single-use items for mRNA manufacturing.

Press Release

DNA template manufacturing: Benefit from our cooperation with Touchlight

A critical starting material for mRNA manufacturing is template DNA. Our partner Touchlight has developed a cell-free enzymatic DNA manufacturing process, with advantages of speed, quality, capacity, and scalability. Due to the collaboration agreement between Lonza and Touchlight our customers can get seamless access to Touchlight’s doggybone DNA technology.

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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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Related Offerings

mRNA / LNP Process Development

We support you and the development of a cGMP compliant manufacturing process once you have selected your lead compound.

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mRNA / LNP Analytical Services

We provide mRNA Drug Substance (DS) and mRNA/LNP formulated Drug Product Intermediate (DPI) analysis all with clear accountability.

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Lipid Nanoparticles Encapsulation

Access Lipid Nanoparticle (LNP) manufacturing for mRNA in an integrated process to avoid cumbersome shipment.

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Biologics Regulatory Services

Partner with our dedicated biologics regulatory team to define the optimal regulatory strategy for your therapy's accelerated pathway to...

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Biologics

Related Insights

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White paper

Exploring Technologies for cGMP Success with Encapsulation of Nucleic Acid-based Therapeutics

In this white paper, we discuss the challenges and opportunities associated with nucleic acid...

Article

mRNA Research Services to Accelerate Your Project

Technical/Service brief

The Early Advantage for mRNA

Our mRNA research services offer you an easy approach to simplify and accelerate your mRNA/LNP...

Webinar (on-demand)

Deciphering mRNA Immunogenicity: What, Why and How of Early Assessment of Human Immune Response of...

This on-demand webinar focuses on strategies to assess the potential for human immune response...

Webinar (on-demand)

How to Bring (Any) mRNA to Life - Simplifying Nucleic Acid Encapsulation

Current delivery systems for the encapsulation of Nucleic Acids have strengths and weaknesses. In...

Article

Simplify the Encapsulation Process of Nucleic Acid Payloads with FDmiX Technology

Enable a reliable, swift scale-up to cGMP manufacturing for mRNA encapsulation with the high-end...

Presentation (slides)

Optimizing GMP Manufacturing of Lipid Nanoparticles

Lonza is now offering next-generation encapsulation of nucleic acids with FDmiX. In this...

Article

Successfully Transitioning mRNA Production to cGMP Requires Early Process Engagement for Developing...

Discover why early process optimization is key to developing an efficient, cost-effective cGMP...

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Regulatory expertise

Pathway to success in Regulatory filings

Extensive Regulatory Expertise

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We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.

Dedicated Regulatory Affairs Contact

We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.

Keep Pace with Regulatory Thinking

Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.