mRNA vaccines & therapies
Bioprocessing solutions for the mRNA revolution
Messenger RNA (mRNA) vaccines and therapies have the potential to provide powerful clinical benefit beyond infectious disease – thanks to a simple, robust and scalable manufacturing process. mRNA vaccines use artificially created mRNA to “teach” cells to make a specific protein that triggers an immune response in the person who receives the treatment. Other mRNA therapeutics produce a protein to compensate for a defective or missing gene or protein.
mRNA vaccine and therapy manufacturing is rapid but also relatively simple. mRNA is produced through an enzymatic process that doesn’t require cell culture and the subsequent removal of host cell proteins. This process starts with production of a plasmid containing DNA, which is then converted into mRNA through in vitro transcription. The mRNA is then purified and concentrated. Finally, it is encapsulated in lipid nanoparticles for delivery into the body.
Vaccines created this way were first approved during the COVID-19 pandemic, and Avantor® partnered with multiple customers to support the scale up to mass produce the vaccine.
Avantor supplies a wide range of cGMP chemicals and reagents, chromatography resins, and aseptic fluid handling solutions to help researchers and manufacturers develop and scale up mRNA vaccines and therapies. Our skilled associates have extensive process optimization knowledge and can help your team overcome obstacles in mRNA vaccine and therapy workflows.
Solutions for every stage of the mRNA vaccine and therapy manufacturing workflow
Plasmid DNA (pDNA) is the starting point of mRNA vaccines and therapies, and its design and purity are critical to optimizing mRNA therapeutics. Avantor provides a wide range of high performance salts, buffers and reagents, as well as Avantor J.T.Baker® brand BAKERBOND® chromatography resins, which are essential to the production and isolation of high purity pDNA.
In vitro transcription
In vitro transcription (IVT), the enzymatic conversion of pDNA to mRNA, is the most critical step in mRNA vaccine and therapy production. The enzymes used in this process require optimal buffer conditions for the reaction to occur. Avantor supplies high purity cGMP reagents, such as dithiothreitol, magnesium chloride, Tris HCL, and sodium chloride, which are well characterized and mitigate the risk of impurity contamination during mRNA production.
Following the IVT reaction, the mRNA product must be purified through chromatography. Avantor J.T.Baker® brand BAKERBOND® reverse phase and anion exchange chromatography resins give your mRNA vaccine and therapy production teams the ability to eliminate impurities during this step in the process. Avantor associates' expertise in chromatography resins, together with our wide offering of buffers, salts and reagents, gives your team confidence that the final product will meet the specifications required of mRNA vaccines and therapies.
Formulation, fill, and finish
The most common formulation for mRNA vaccines and therapies is lipid nanoparticle (LNP) encapsulation. Cholesterol is a vital component of LNPs and maintains LNP stability – and facilitates cellular intake. Avantor supplies a wide range of buffers, sugars, salts and surfactants that prevent mRNA degradation during manufacturing and handling. These products also improve the stability of mRNA vaccines and therapies, prolonging shelf-life. Additionally, we offer packaging materials, such as vials and stoppers, that meet stringent internal and external quality requirements.
Fluid handling for mRNA vaccines and therapies
Avantor can support every stage of your mRNA vaccine and therapy production process with end-to-end fluid handling solutions. This includes tubing, connectors, assemblies and pumps for aseptic fluid handling and storage across all stages of your workflow. Additionally, Avantor buffer management optimization strategies enable manufacturers to reduce facility footprint, equipment cost, and labor requirements by providing hydrated, premade liquid buffers and buffer concentrates.