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mRNA Manufacturing and Formulation

Unleashing the power of mRNA technology to revolutionize how diseases are treated and prevented relies on robust and consistent processes to make the mRNA and then purify and formulate it. Our mRNA manufacturing template provides a robust workflow, while our lipid nanoparticle (LNP) manufacturing processes ensure a high-quality and consistent supply. Our portfolio and services, including our mRNA CDMO and testing services, address the most critical challenges in mRNA manufacturing enabling fast timelines and high-quality purified drug products.

We also realize that protecting mRNA from degradation risks by RNases or microbial contamination is key to successful mRNA manufacturing, purification, and formulation. That’s why we offer our high-quality pharma raw materials that are tested for endonuclease activity and have low bioburden and endotoxin levels. Our pharma/biopharma raw materials also comply with IPEC-PQG GMP requirements and are part of the Emprove®Program. The program offers comprehensive regulatory documentation and covers also some of our filters and single-use components and selected chromatography resins.


Related Technical Articles

  • mRNA technology uses non-viral delivery systems and offers a great deal of versatility. Delivery of an mRNA into the cytosol of a cell can induce the production of a target protein which can function as a therapeutic or prophylactic, act as an antigen to trigger an immune response for vaccination purposes, replace a defective protein or activate an anti-tumor response.

Plasmid DNA Production, mRNA Synthesis, and mRNA Purification Products

Our products can be used for the entire mRNA synthesis workflow from generating plasmid DNA to synthesizing mRNA and finally to purifying mRNA. They come in a variety of sizes so that you can scale up from development to suit your production goals. These include:

These materials can also be used during the mRNA formulation steps.

mRNA Contract Development and Manufacturing Services

Our integrated CDMO capabilities include the development and manufacture of custom mRNAs. With our proven AmpTec workflow, mRNA manufacturing is highly reproducible. Key features include:

  • Production of fully customizable sequences up to 13,000 nucleotides
  • A significantly lower requirement (~10,000x) for plasmid DNA compared to standard mRNA manufacturing processes
  • Highly reproducible process yielding mRNA with a homogeneous poly A tail and high performing product

Lipid Nanoparticle Formulation

Our portfolio lipids and custom lipid synthesis services help you bring your formulation to scale. As naked mRNA is unstable, drug delivery systems, such as lipid nanoparticles, are necessary to deliver mRNA to target cells. Selecting the right excipient and lipids is essential for successful encapsulation. We provide:

Cell Banking and Storage

Banking and storing your strains or plasmids are crucial parts of the mRNA manufacturing process. We offer banking and storage space for your stocks in various biorepository and storage facilities around the globe. You can also choose from our master viral seed stocks.

Facility Engineering Services

If you’re looking to build your own mRNA biomanufacturing facility, we can provide guidance in designing, building, and operating a safe and flexible GMP manufacturing facility. To learn more, download our guidebook “Break Down Roadblocks to Clinical Success.”

mRNA Testing Services

Our BioReliance® testing services support you through every stage your mRNA therapy's journey. We’ll help you through the required testing for regulatory compliance including:


Our Products and Services Support the Following Areas

Research

Test
• Antigen Discovery Products
• mRNA Synthesis
• LNP Selection and Formulation

    Development

    mRNA-development
    • Characterization and Method Development
    • Plasmid DNA Production and mRNA Synthesis & Purification
    • mRNA Contract Development and Manufacturing Services
    • Lipid Nanoparticle Formulation (LNP)
    • Preclinical Assessment
    • mRNA Development Services

      Manufacturing & Formulation

      mRNA-manufacturing-and-formulation
      • mRNA Synthesis and Purification Products
      • mRNA Contract Development and Manufacturing Services
      • Lipid Nanoparticle Formulation (LNP)
      • Cell Banking and Storage
      • Facility Engineering Services
      • mRNA Testing Services

        Analytical & Quality Control

        mRNA-analytics-and-quality-control
        • Analytical Quality Control
        • Microbial Quality Control