Accelerating your mRNA therapeutic and vaccine production

Producing mRNA for process development and cGMP commercial manufacturing of mRNA therapeutics or vaccines requires strategic decision-making regarding essential raw materials. Key considerations for critical raw materials include:

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

Streamline and expedite the production of your mRNA therapeutic or vaccine, guiding them seamlessly from preclinical development to commercialization with Thermo Scientific's TheraPure portfolio. This wide ranging product line encompasses restriction enzymes, in vitro transcription enzymes, nucleotides, modified nucleotides, and mRNA capping systems.

These fit-for-purpose, meticulously produced solutions cater to your quality and scalability needs while supporting your process requirements and regulatory standards.

mRNA production materials

mRNA production involves template linearization, in vitro transcription, DNA removal, and post-transcriptional modification. Below is a summary of many of the materials typically used in mRNA production.


mRNA building blocks

In vitro transcription

mRNA modification


Modified nucleotides

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

Capping systems
Poly(A) polymerase
S-adenosyl methionine

TheraPure and TheraPure GMP mRNA production solutions

Thermo Fisher Scientific offers two types of products for mRNA production: TheraPure and TheraPure GMP*. 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 GMP material, which is manufactured with added process controls and includes documentation to support regulatory submissions, is recommended.

  • TheraPure—Advancing Early Development and Process Optimization - TheraPure grade materials are an ideal choice for your initial stages of process development. Whether you are focused on proof of concept, process research, or engaged in preclinical studies, TheraPure materials provide the flexibility and capabilities you need for process development and optimization.
  • TheraPure GMP—Meeting Clinical and Commercial Demands - As your mRNA production progresses toward clinical trials and commercial cGMP manufacturing, TheraPure GMP materials step in. Manufactured with stringent process and quality controls and accompanied by comprehensive documentation to support regulatory submissions, TheraPure GMP is the recommended choice.

TheraPure and TheraPure GMP product quality attributes

Product attributeStandardTheraPureTheraPure GMP
Large-scale (grams to kgs) production quantities availableNoYesYes
Animal origin free (AOF) manufacturing processes and materialsLimited (as specified)YesYes
Animal origin– and β-lactam–free manufacturing equipment and facilitiesNoNoYes
Manufacture and documentation follows ICH Q& GMP guidelinesNoNoYes
Validated product-specific manufacturing processes and analytical methodsNoNoYes
Product specific stabilityNoNo (Product family only)Yes
Animal origin and B-lactam free manufacturing equipment and facilitiesNoNoYes
Melamine statementNoNoYes
Nitrosamine statementNoNoYes
Impurity profileNoNoYes
Comprehensive regulatory support documentation NoLimited (TSE/BSE, COO, COA only)Yes
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. 

Connect with us and speak with a specialist about how we can support your mRNA therapeutic development.

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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.

Use of the products may vary. For specific use statements, please see product literature.

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