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Expert mRNA Production

Welcome to Wacker Biotech, your trusted expert CDMO partner for mRNA production. Our expertise spans the entire nucleic acid manufacturing chain, from template DNA to mRNA to LNP (lipid nanoparticle) formulation. Whether it's for prophylactic vaccines or advanced gene therapies, we are here to support your journey.

mRNA Innovation and Experience

At Wacker Biotech, innovation is at the heart of what we do. Even before Covid-19, Wacker Biotech has been pioneering in the mRNA space. Our dedicated team of research scientists in Munich is constantly pushing the boundaries of nucleic acid therapeutics, developing patented technologies and forging valuable industry and academic collaborations.

With GMP production experience of a leading mRNA vaccine for Covid-19 pandemic and a high-end mRNA Competence Center in Halle, Germany, we ensure proven top-notch quality and reliability for our customers.

mRNA Capabilities

mRNA Design
A dedicated R&D team to support customers in developing new RNA technologies and designing your target mRNA product.
Development of End-to-End Processes
Process development for all steps along the full production path: from plasmid DNA to LNP formulation.
Technology Transfer
Flexible and experienced MSAT teams for transfer of customized mRNA processes.
Plasmid DNA Supply
In-house PLASMITEC^® platform to accelerate your process with a ready plasmid DNA supply for the DNA template.
Analytical Capabilities
Proprietary analytical panel for RNA products (capping efficiency, poly A tail length, dsRNA), including analytical capabilities to test RNAs and LNPs in cell culture.
GMP Manufacturing
Small and large-scale mRNA production including post-transcription capping and tailing using RNA-modifying enzymes to improve mRNA stability and protect against degradation, as well as encapsulation of the target RNA molecule in a lipid nanoparticle (LNP, via AI and microfluidics). Learn more about our state-of-art mRNA facilities and manufacturing capabilities. And read more about our LNP formulation here.

We Cover the Following Types of RNA

Linear mRNA
Circular mRNA
Self-amplifying RNA
SiRNA
SeRNA (selectively expressed)

Key Benefits of Wacker Biotech’s mRNA Services

Reduced Time and Cost
End-to-end partner for mRNA production, including reliable and economic delivery of template DNA, saving you time and cost.
Analytical Confidence
Confidence in the quality of the drug substance with our comprehensive in vitro analytical panel (to test capping efficiency, poly A tail length, encapsulation efficiency, dsRNA, integrity, etc.).
Flexibility and Scalability
Multiple GMP production lines to meet your needs at different scales, with the ability to scale from mg to g to kg scale within a few months.
Continuous Innovation
Innovative research by our central R&D team on novel RNA synthesis pathways (e.g., mRNA, saRNA, circRNA), plus formulation compositions and new lipids.
Highest Quality and Reliability
Proven standards assessed and qualified by the German Government when selecting Wacker Biotech as a pandemic preparedness partner.

Ready to Partner with Us?

Discover how Wacker Biotech can transform your biopharmaceutical production. Contact us today to learn more about our innovative solutions and how we can help you achieve your goals. Reach out to our team for more information.

Learn More about the mRNA Production Process

The RNA biotherapeutic production process begins with the identification of the target RNA sequence to be encoded in template DNA (e.g. plasmid DNA(pDNA)). This template DNA can be generated either by the client or by Wacker Biotech using our proprietary PLASMITEC^® platform for pDNA. In case of a plasmid, the next step is the linearization, which forms the basis of the template DNA for in vitro transcription.

The crucial 5’ cap of an mRNA or saRNA can either be included during the transcription (co-transcriptional) or can be added in a post-transcriptional enzymatic capping step. Likewise, the important poly A tail of an mRNA or saRNA can be either added during the transcription, when the poly A tail segment is encoded in the template, or alternatively, it can be added post-transcriptionally using poly adenylation enzymes. Subsequently to the synthesis of the RNA including all necessary modifications and features, the target RNA undergoes various different purification options, depending on the target product profile. Finally, the RNA can be embedded into the LNP for its successful delivery.

Product/Customer Spotlight

Pantherna Therapeutics

Customer: Pantherna Therapeutics
Product: PAN004, active ingredient based on mRNA and lipid nanoparticles (LNPs) for combating acute respiratory distress syndrome (ARDS)
Scope: Process development and production of the whole nucleic acid manufacturing chain – from starting material and plasmid DNA through to mRNA LNP formulation and dispensed mRNA active

In April 2024, Wacker Biotech and Pantherna Therapeutics announced a partnership to produce the mRNA/LNP-based drug PAN004, a novel experimental therapeutic for acute respiratory distress syndrome (ARDS) targeting the Angiopoietin-1/2 system. Production of a clinical supply for dose range finding studies is expected to begin in 2025.

Pantherna and Wacker Biotech have been collaborating since 2022. As part of a joint research project, both companies initially developed a tailored manufacturing process for mRNA-based active ingredients, modifying WACKER’s own process. The plasmid-based template DNA, yield and critical parameters were all optimized by focusing on process scalability. The LNP manufacturing process based on Pantherna’s proprietary LNP formulation technology PTXΔLNP© was transferred from Pantherna to Wacker Biotech as part of this project. The resulting mRNA/LNP product was, in turn, evaluated by Pantherna in a cell culture model.

We have established a very good collaborative R&D footing with WACKER and value its broad expertise in the production of mRNA active ingredients – expertise that we were able to use to turn our innovative technology into a product. WACKER plays a special role in the market, as it combines many years of experience in the toll manufacturing of complex biopharmaceuticals with the capabilities of its own Corporate R&D unit. We are delighted to now see our innovative mRNA active ingredient move from the laboratory to regulated production. This marks an important milestone for our company and opens a new chapter in our joint collaboration.

Dr. Jörg Kaufmann (Pantherna CSO)