mRNA/LNP Development and Manufacturing Services

Partner with a CDMO experienced in cGMP mRNA/LNP manufacturing for seamless clinical-to-commercial development. Our integrated services simplify mRNA formulation complexities.

Success in mRNA manufacturing depends on precise process management and a streamlined supply chain. We provide a reliable DNA sourcing strategy, efficient in vitro transcription with advanced capping, stable LNP encapsulation, and sterile vial filling - all within our cGMP-compliant network.

We also manufacture circular and self-amplifying mRNA, along with other in vitro transcription-based mRNA forms. Our flexible tech transfers, scalable manufacturing models, and global network ensure smooth progression from early development to commercialization.
Learn more about these services at Lonza below.

Expanding Our mRNA Clinical Manufacturing Services

To meet growing demand, we’ve expanded our mRNA clinical manufacturing services in Geleen, Netherlands, enabling immediate tech transfers and process development for clinical-stage projects.

Why Partner With Lonza?

Extensive cGMP experience supporting the development and approval of mRNA/LNP products.
Expertise across all mRNA/LNP manufacturing modalities, all under one Quality System.
Leading LNP technologies, with ongoing innovation to enhance encapsulation at clinical and commercial scales.
Proven supply chain leadership, with experience sourcing mRNA/LNP products during critical times.
Firsthand experience with regulatory submissions for an mRNA/LNP vaccine.

What are mRNAs?

Messenger RNAs (mRNAs) represent a fast-emerging class of biotherapeutics. They hold considerable promise, offering new opportunities for targeted treatment and flexible manufacturing, as was recently demonstrated by the rapid development of mRNA-based COVID-19 vaccines.

In recent years, we at Lonza have amassed considerable expertise in the commercial manufacturing of mRNA and its encapsulation in Lipid Nanoparticles (LNP) at cGMP quality.

DNA template supply

The DNA template is essential for mRNA manufacturing and starting in vitro transcription. At Lonza, you can choose the best source for the DNA template, and we’ll guide you in selecting the right supplier and provide you with an efficient IVT process for optimal results. Whether you prefer pDNA from E. coli or synthetic Doggybone™ DNA from our partner Touchlight, we handle the complexities for you.

Analytical development (AD)

We have combined analytical development (AD) and process development (PD) at a single site, offering several benefits for your testing needs. By having AD and PD together, you can use the same mRNA assay for your mRNA Drug Substance, mRNA/LNP Drug Product Intermediate, and finished Drug Product.

This eliminates the need for complex tech transfers between different labs and greatly reduces the risk of inconsistencies in test results. Our mRNA team is highly experienced with compendial methods for mRNA/LNP formulations and has access to key technologies, including in-house mass spectrometry and cell-based bioassays. Additionally, you’ll benefit from the expertise of our broader global Lonza network.

mRNA manufacturing

We aim for smooth tech transfers and work to make your processes more stable. With extensive experience in mRNA/LNP manufacturing, we’ve successfully delivered large amounts of cGMP-compliant material. We recommend starting with a traditional service model focused on supplying batches and clear deliverables. Our flexible collaboration options include dedicated suites and pricing models based on output or input, giving you more control over batch production.

When you're ready to scale to commercial development, you can easily transition to a different scale within the Lonza network. Compared to building your own manufacturing facility, our services offer greater flexibility and lower financial risk.

mRNA/LNP process development (PD)

Once you’ve chosen your lead compound, we’ll help you develop a cGMP-compliant manufacturing process. With our deep understanding of cGMP requirements and expertise in mRNA/LNP manufacturing, we’ll work with you to define the best process.

Whether you need a new IVT/LNP cGMP process for your mRNA compound or want to tech transfer and optimize your current process, our skilled team in Geleen, the Netherlands, is ready to assist. Our scientists and engineers have access to 30,000 square feet of labs, clean rooms, offices, storage and other facilities to support your project.

Lipid Nanoparticle encapsulation

In Geleen, we use various advanced technologies for lipid mixing and LNP encapsulation, allowing us to provide customized solutions for your needs. We continuously improve our encapsulation technology to ensure smooth scaling from early clinical to commercial stages.

With both mRNA manufacturing and LNP encapsulation at the same site, you avoid the hassle of shipping mRNA between locations, reduce the need for extra freezing and thawing, and benefit from a unified analytical and quality control team. We also offer “standalone” LNP process development and manufacturing services, including preparing your in vivo LNP-mediated CRISPR gene-editing therapy for cGMP compliance.

Fill & Finish

If you want to simplify and streamline your processes, we offer Fill & Finish services for your mRNA drug substance or LNP-encapsulated mRNA intermediate. At our Swiss Center of Excellence for Drug Product Services, we have multiple filling lines to support both clinical and commercial manufacturing.

Regulatory

Take advantage of our regulatory services for writing CMC documents, supporting your CMC strategy, and assisting with Health Authority meetings. We have successfully helped develop and approve an mRNA/LNP product, so we can offer you valuable hands-on regulatory experience from start to finish. Our team also has the expertise to guide you through interactions with Health Authorities worldwide, helping you reduce risk and adopt a "right-first-time" approach.