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mRNA Manufacturing Process |
Key steps in the mRNA manufacturing process
Thermo Fisher Scientific's mRNA vaccines and therapeutics solutions are tailored to you and seamlessly accelerate progression from development to clinical trials to commercial manufacturing.
Accelerate your mRNA vaccine and therapeutics from preclinical development to commercialization with our comprehensive portfolio of products and services proven to help meet critical process, scale, quality, and regulatory needs.
Target gene design and IVT template production
Target genes for mRNA therapeutics and vaccines are often discovered and validated using techniques, such as next generation sequencing (NGS). The target sequence will be selected, optimized, synthesized, and inserted into a DNA plasmid to use as a template for mRNA synthesis using in vitro transcription that will be used to produce the mRNA therapeutic or vaccine. Actively evolving alternatives to plasmid DNA for amplifying target sequences include PCR or isothermal amplification technologies (e.g. RCA—rolling circle amplification).
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Plasmid purification and linearization
DNA plasmids are produced in sufficient quantities using bacteria grown in single-use fermenters. The resulting plasmid products are purified, tested for contaminants, and treated with restriction enzymes to linearize the plasmid DNA template for mRNA synthesis.
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mRNA synthesis
In vitro transcription uses the linearized DNA template, nucleotides, and enzymes to synthesize mRNA in a single use bioreactor. The resulting mRNA product can be modified to enhance protein translation, improve stability, or reduce immunogenicity as required.
An innovative solid-phase in vitro transcription solution is made available to facilitate the reuse of DNA template, minimizing the effort needed for plasmid preparation whilst maximizing the mRNA productivity in a scale ranging from microgram to gram quantities of mRNA.
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mRNA purification
The final mRNA product is isolated and purified using magnetic bead-based, affinity, or other chromatography and filtration techniques. After purification, the mRNA is tested for purity and for the presence of undesirable immunostimulatory RNA side products.
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mRNA analytics
Purified mRNA is characterized at the molecular level to verify sequence and to assess mRNA modifications. The lipid nanoparticle (LNP) component of the mRNA vaccine or therapeutic formulation is also analyzed for lipid composition and purity. Understanding the exact molecular composition of both components is critical to ensure the final drug product meets rigorous quality and regulatory standards.
Featured products
- Vanquish Horizon UHPLC and Orbitrap Exploris Mass Spectrometers
- Residual host cell DNA quantitation
- Applied Biosystems SeqStudio Flex series genetic analyzers for Sanger sequencing
Formulation, fill, and finish
An mRNA therapeutic or vaccine is formulated by compounding mRNA with a delivery vehicle, such as an LNP or other lipids or carbohydrates. Once formulated, the mRNA containing drug product is processed into the final vaccine or therapeutic, sterilized, aseptically filled, and packaged. The filled packages undergo final testing and are loaded into ultra-low temperature freezers for storage and delivery.
Featured products
Target gene design and IVT template production
Target genes for mRNA therapeutics and vaccines are often discovered and validated using techniques, such as next generation sequencing (NGS). The target sequence will be selected, optimized, synthesized, and inserted into a DNA plasmid to use as a template for mRNA synthesis using in vitro transcription that will be used to produce the mRNA therapeutic or vaccine. Actively evolving alternatives to plasmid DNA for amplifying target sequences include PCR or isothermal amplification technologies (e.g. RCA—rolling circle amplification).
Featured products
Plasmid purification and linearization
DNA plasmids are produced in sufficient quantities using bacteria grown in single-use fermenters. The resulting plasmid products are purified, tested for contaminants, and treated with restriction enzymes to linearize the plasmid DNA template for mRNA synthesis.
Featured products
mRNA synthesis
In vitro transcription uses the linearized DNA template, nucleotides, and enzymes to synthesize mRNA in a single use bioreactor. The resulting mRNA product can be modified to enhance protein translation, improve stability, or reduce immunogenicity as required.
An innovative solid-phase in vitro transcription solution is made available to facilitate the reuse of DNA template, minimizing the effort needed for plasmid preparation whilst maximizing the mRNA productivity in a scale ranging from microgram to gram quantities of mRNA.
Featured products
mRNA purification
The final mRNA product is isolated and purified using magnetic bead-based, affinity, or other chromatography and filtration techniques. After purification, the mRNA is tested for purity and for the presence of undesirable immunostimulatory RNA side products.
Featured products
mRNA analytics
Purified mRNA is characterized at the molecular level to verify sequence and to assess mRNA modifications. The lipid nanoparticle (LNP) component of the mRNA vaccine or therapeutic formulation is also analyzed for lipid composition and purity. Understanding the exact molecular composition of both components is critical to ensure the final drug product meets rigorous quality and regulatory standards.
Featured products
- Vanquish Horizon UHPLC and Orbitrap Exploris Mass Spectrometers
- Residual host cell DNA quantitation
- Applied Biosystems SeqStudio Flex series genetic analyzers for Sanger sequencing
Formulation, fill, and finish
An mRNA therapeutic or vaccine is formulated by compounding mRNA with a delivery vehicle, such as an LNP or other lipids or carbohydrates. Once formulated, the mRNA containing drug product is processed into the final vaccine or therapeutic, sterilized, aseptically filled, and packaged. The filled packages undergo final testing and are loaded into ultra-low temperature freezers for storage and delivery.
Featured products
Resources
Target gene design
Plasmid production and purification
mRNA synthesis
mRNA purification
mRNA analytics
Formulation, fill, and finish
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