MilliporeSigma

mRNA Vaccines and Therapeutics Manufacturing

Advancing mRNA vaccines and mRNA therapeutics manufacturing together

Advancing mRNA vaccines and mRNA therapeutics manufacturing together

The ability to deliver mRNA molecules into the cytosol of a patient cell offers possibilities for a new class of therapeutics to meet patient needs. The power of these versatile molecules to stimulate patient immune responses was clearly demonstrated with the success of COVID-19 vaccines.

Development of mRNA products is relatively straightforward and offers the possibility of rapid, scalable manufacturing using available technologies. The simplified manufacturing workflow through an enzymatic process minimizes the need for extensive process optimization and enables GMP facilities to quickly switch to new target mRNA products.

mRNA products, both therapeutics and vaccines, offer exciting possibilities for new patient treatments but require important considerations:

  • Reliable DNA Template for mRNA Production:
    mRNA production begins with generation of a purified plasmid DNA (pDNA) template. Efficient pDNA separation relies on high-quality chemicals for bacterial cell lysis and purification of pDNA from impurities that could impact mRNA production. mRNA generation from the pDNA template depends on high-quality chemicals and reagents for plasmid linearization, in-vitro transcription, and end capping of the RNA.

  • Optimized mRNA Purification to Maximize mRNA Yield and Recovery:
    Downstream purification removes endotoxins and nucleic acid impurities that impact RNA stability and induce immune responses in patients. mRNA manufacturers commonly rely on tangential flow filtration (TFF), reverse-phase ion-pair, anion exchange (AEX), hydrophobic interaction chromatography (HIC), and affinity chromatography using poly(dT) capture to purify mRNA while maximizing yield and recovery. Easy access to high-quality downstream equipment and chemicals is key to minimizing degradation and establishing an efficient purification process.

  • Efficient mRNA Delivery with Lipid Nanoparticles:
    Lipid nanoparticles (LNPs) protect mRNA from degradation and enable efficient delivery of the molecule when administered to patients. The right lipid type, source, and quality for the LNP needs to be carefully selected based on the delivery route to achieve the desired biodistribution and efficacy profile.

  • Dedicated Support for Risk Assessment and Regulatory Compliance:
    An important aspect of new product development is to navigate the regulatory framework, manage risks, and improve manufacturing processes. Reliable technical and regulatory information coupled with a well characterized and transparent supply chain minimizes risk, simplifies risk assessment, and accelerates speed to market.

For high-quality raw materials for mRNA manufacturing and LNP formulation explore also our brochure.


It is a blue line drawing of a microorganism culture or multiple cells scattered in a Petri dish.

Make

Overcome the challenges of pDNA production: high quality chemicals and efficient separation streamline mRNA production.

Plasmid DNA (pDNA) Manufacturing Process
Get a step-by-step overview of pDNA manufacturing and the challenges in pDNA purification.

pDNA Linearization and in Vitro Transcription With Single-Use Mixers 

Buffers & pH Adjusters

Liquid Cell Culture Media & Buffers

Sterilizing filters

mRNA CDMO Services

    The image shows a blue outlined equipment which is user for purification.
    There are three separate structures made of blue circles connected by lines, resembling molecular models. Each structure consists of multiple circles interconnected in a non-linear fashion, giving an impression of complexity and diversity. The blue color is uniform across all the structures and their connecting lines.
    Final Sterile Filtration & Filling is the last step in the product process and consists of two elements, gas filters, and barrier filters.

    Reliable and robust sterile filtration, and final filling of the mRNA vaccines and therapeutics is essential to assure patient safety. 

    Final Sterile Filtration

    Single Use Fill-Finish Solutions

    Sterile Sampling

    Single-Use Solutions for Final Filtration and Filling

    Sterile Filtration Strategies

    Final Fill Strategies

    Single Use and Filter Validation Services

      An illustration of a projector connected to a computer monitor displaying a line graph.

      Process analytical technology (PAT) and analytics software can be used to build quality into various manufacturing processes by monitoring and controlling the process.

      PAT: Build Quality into Biopharmaceutical Processes

      Bioprocessing Data Analytics Software

      Bioprocessing Automation and Control Software

        The image features a 3D letter “N” in a vibrant teal color. Miniature figures of people are seen climbing and hanging on various parts of the “N,” each equipped with climbing gear and ropes.

        The Emprove® Program complements our broad product and chemicals portfolio with convenient access to reliable technical, regulatory and supply information in Emprove® Dossiers to support your risk assessment continuum and compliance requirements.

        Emprove® Program

        Emprove® Chemicals Portfolio



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