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Key steps in the mRNA manufacturing process
Accelerate mRNA vaccine and therapeutics from pre-clinical development to commercialization with our comprehensive portfolio of products and services proven to meet critical process, scale, quality, and regulatory needs.
Target gene design and plasmid 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.
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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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* “TheraPure GMP” refers to the quality level of the raw, ancillary, or starting materials to be used for further manufacturing. TheraPure GMP products are manufactured in facilities with ISO 9001–certified quality management systems that operate in accordance with relevant good manufacturing practice (GMP) principles, as outlined in ICH Q7 or equivalent guidance documents or standards.
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
- ResDNASEQ Residual DNA analysis kit
- 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 plasmid 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.
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
* “TheraPure GMP” refers to the quality level of the raw, ancillary, or starting materials to be used for further manufacturing. TheraPure GMP products are manufactured in facilities with ISO 9001–certified quality management systems that operate in accordance with relevant good manufacturing practice (GMP) principles, as outlined in ICH Q7 or equivalent guidance documents or standards.
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
- ResDNASEQ Residual DNA analysis kit
- 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
