TheraPure solutions for mRNA production

Producing mRNA for process development and cGMP commercial manufacture of an mRNA therapeutic or vaccine requires careful choices in many key raw materials. Critical raw material considerations include:

  • Quality
  • Flexibility
  • Scalability
  • Consistency
  • Proven products
  • Regulatory support

Accelerate mRNA vaccine and therapeutics production from preclinical development to commercialization with the portfolio of Thermo Scientific TheraPure restriction enzymes, in vitro transcription enzymes, nucleotides, and capping solutions that are designed to meet critical process, scale, quality, and regulatory needs. Partner with us to help accelerate the commercialization of your mRNA vaccines and therapeutics.

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mRNA production materials

mRNA production involves template linearization, in vitro transcription, DNA removal, and post-transcriptional modification. The figure below summarizes many of the materials typically used in mRNA production.

Ball and stick molecular model of a simple compound

mRNA building blocks

Nucleotides
ATP, CTP, GTP, UTP

Modified nucleotides
N1-methylpseudo-UTP

A bioreactor used for mRNA synthesis using in vitro transcription

In vitro transcription

Restriction enzymes
T7 RNA polymerase
Pyrophosphatase, inorganic
RNase inhibitor
DNase I
Proteinase K

mRNA strands with poly A tails

mRNA modification

Capping systems
Poly(A) polymerase
2′-O-methyltransferase
S-adenosyl methionine

TheraPure and TheraPure Plus portfolios for mRNA production

Thermo Fisher Scientific offers two grades of nucleotides and enzymes for mRNA production: TheraPure and TheraPure Plus. TheraPure grade materials are recommended for process optimization and early development (proof of concept, research, and preclinical studies). Upon transitioning to clinical and commercial cGMP manufacturing, TheraPure Plus grade material, which is manufactured with added process controls and includes documentation to support regulatory submissions, is recommended.

  • TheraPure products are designed and recommended for use in process development and optimization
  • TheraPure Plus products are designed and recommended to support production for clinical trials and commercial cGMP manufacture


TheraPure and TheraPure Plus product attributes

Product attributeStandardTheraPureTheraPure Plus
Large scale production (grams to kilograms of mRNA)NoYesYes
AOF production process and raw materials (TSE-/BSE-free)Limited (as specified)YesYes
Regulatory support documents availableNoLimited (TSE/BSE, COO, COA only)Yes
Documentation follows ICH Q7 GMP guidelinesNoNoYes
Validated product specific process and analytical methodsNoNoYes
SKU specific product stabilityNoNo (Product family only)Yes
Animal origin-free manufacturing equipmentNoNoYes
β-lactam-free manufacturing facilityNoNoYes
Melamine statementNoNoYes
Nitrosamine statementNoNoYes
Impurity profileNoNoYes
Material safety risk assessment (including latex and antibiotic use)NoNoYes
Recommended useResearch Use OnlyProof of concept, research, and pre-clinical developmentClinical and commercial manufacturing

The TheraPure portfolio of products can also be custom formulated to meet your process development and manufacturing needs. Many of these products have been consistently manufactured at a global scale and have been successfully used in several mRNA therapeutics and vaccines.

TheraPure product portfolios for mRNA production

mRNA building blocks

Nucleotides are critical building blocks for producing revolutionary mRNA-based medicines. Thermo Scientific TheraPure nucleotides and modified nucleotides are proven raw material components for quickly and successfully developing mRNA therapeutics and vaccines.

Nucleotide portfolio

NucleotidesModified nucleotides
Adenosine triphosphate (ATP)
Cytosine triphosphate (CTP)
Guanosine triphosphate (GTP)
Uridine triphosphate (UTP)
N1-Me Pseudo UTP
Pseudo UTP
5-Methoxy UTP
1-Ethyl Pseudo UTP
N4-Acetyl-CTP
In vitro transcription

Enzymes are fundamental in producing new mRNA-based medicines. Thermo Scientific TheraPure enzymes were specifically designed to facilitate the development of mRNA vaccines and therapeutics. TheraPure enzymes can be utilized for DNA template linearization, in vitro transcription, post-transcriptional modifications, and removal of DNA template and enzymes.

In vitro transcription enzyme portfolio

Restriction enzymesIn vitro transcriptionPost in vitro transcription clean up
EcoRI
Eam1104I
Lgul
T7 RNA polymerase
Pyrophosphatase, inorganic
RNAse inhibitor
5X transcription buffer
DNase I
Proteinase K
mRNA modification

Adding a nucleotide cap and poly-A tail to mRNA are essential for the function and stability of an mRNA vaccine or therapeutic. TheraPure enzymes help make these mRNA modifications easy.

mRNA modification portfolio

mRNA enzymatic cappingmRNA tailing
Vaccinia capping enzyme
Vaccinia Cap 2’-O-Methyltransferase
S-adenosyl-methionine (SAM)
10X capping buffer

Poly(A) polymerase

Resources

For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.