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:
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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.
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mRNA building blocks | In vitro transcription | mRNA modification |
Nucleotides Modified nucleotides | Restriction enzymes | Capping systems |
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 attribute | Standard | TheraPure | TheraPure GMP |
|---|---|---|---|
| Large-scale (grams to kgs) production quantities available | No | Yes | Yes |
| Animal origin free (AOF) manufacturing processes and materials | Limited (as specified) | Yes | Yes |
| Animal origin– and β-lactam–free manufacturing equipment and facilities | No | No | Yes |
| Manufacture and documentation follows ICH Q& GMP guidelines | No | No | Yes |
| Validated product-specific manufacturing processes and analytical methods | No | No | Yes |
| Product specific stability | No | No (Product family only) | Yes |
| Animal origin and B-lactam free manufacturing equipment and facilities | No | No | Yes |
| Melamine statement | No | No | Yes |
| Nitrosamine statement | No | No | Yes |
| Impurity profile | No | No | Yes |
| Comprehensive regulatory support documentation | No | Limited (TSE/BSE, COO, COA only) | Yes |
| Recommended use | Research Use Only | Proof of concept, research, and pre-clinical development | Clinical 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.
Resources
* “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.