Lipid Nanoparticle Formulation (LNP)

Wacker Biotech is your expert partner for lipid nanoparticle (LNP) formulation. We can work with you to produce custom LNPs, or we can collaborate to build these on behalf of our clients via partner relationships, such as our relationship with CordenPharma.

The last step in the manufacturing chain for mRNA-based vaccines and advanced therapies, LNP formulation involves packaging the therapeutic cargo inside LNPs. The significant advantage of LNPs is their ability to deliver mRNA and other nucleic acid-based pharmaceuticals safely and effectively to the human body.

LNP Innovation and Expertise

Wacker Biotech innovates in LNP formulation, which requires a delicate balance of different lipids and mixing phases.

A multi-component ethanol phase often contains:

Ionizable lipids that facilitate cellular uptake of mRNA
Helper phospholipids
Cholesterol to serve as a structural lipid
Helper PEGylated lipids
Excipients such as surfactant emulsifiers, e.g., to stabilize the LNPs during freeze/thaw cycles

An acidic aqueous T-mixer phase containing the mRNA, which is merged with the ethanol phase in a mixing process to yield the lipid nanoparticles.

LNP Capabilities

Our LNP capabilities for preclinical and clinical supply span the following areas:

Preclinical trial manufacturing
Microfluidics or impinging jet mixing for LNP production
Cryoprotectant screenings

Cell culture assays for functional LNP testing – covering multiple areas:

LNP uptake
Transfection efficiency (mRNA translation)
Immune response
Cellular viability

Key Benefits of Wacker Biotech’s LNP Capabilities

Scalable Capacity
Our flexible GMP capacity for LNPs ranges from .02 up to 400 L for microfluidics and from 1 up to 3000 L for T-mixer.
Continuous Innovation
Our specialized 30-person nucleic acids R&D team in Munich is continually innovating new LNP formulations and analytics, including forging collaborations with academic and industry partners pioneering in the LNP space.
Cutting-Edge and Proven LNP Formulation Expertise
We have produced high-quality LNPs for clients such as Pantherna Therapeutics, with whom we are partnering to develop an mRNA therapeutic targeting Angiopoietin-1 for acute respiratory distress syndrome.
Deep Analytical Expertise
We offer an extensive in-house analytical panel covering multiple areas:
- Purity: Assessment of lipid purity via HPLC. Assessment of residual solvent purity via gas chromatography outsourced to a qualified partner.
- Content: Analysis of lipid content via HPLC and mRNA content via RiboGreen.
- Integrity: Analysis of particle size and charge, particle distribution, Zeta potential, stability, mRNA integrity, and encapsulation efficiency.
- Identity: Characterization of lipid identity via HPLC and mRNA identity via HPLC and/or CE (capillary electrophoresis). Sanger sequencing outsourced to a qualified partner.
- Safety/General: Validation of absence of microbial contamination and bacterial endotoxins, and testing of pH and osmolality.

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.

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)