Streamline mRNA therapeutics development from preclinical to GMP manufacturing
Proven supplier to help minimize your risks in mRNA therapeutics and vaccine commercialization
Selecting the appropriate raw materials is the essential first-step to expediting the manufacturing process development of mRNA therapeutics and ensuring a smooth transition to commercialization. Thermo Scientific's TheraPure portfolio was created to accommodate your requirements. TheraPure products are designed to support your needs for early process development activities, creating a bridge to TheraPure GMP, which follows the most up-to-date guidelines in compliance to current Good Manufacturing Practice (cGMP), and is an exceptional choice for the late process development and commercialization stages with in-depth documentation.
This comprehensive product line includes restriction enzymes, in vitro transcription enzymes and proteins, nucleotides, modified nucleotides, mRNA capping, and mRNA tailing systems. Our extensive solutions and custom services are designed to meet your specific quality, purity requirements, and scalable batch-to-batch consistency.
Latest technology: Prepare DNA template using isothermal amplification
In addition to offering a secure and dependable supply chain, we are committed to staying ahead of innovative solutions in every step of the mRNA manufacturing process. Isothermal amplification techniques for IVT DNA template amplification are cell-free processes that have been gaining attraction due to high efficiencies as alternatives to technologies such as PCR or plasmid DNA amplification. This trending technology uses polymerase with strand displacement activity to produce and amplify DNA at a constant temperature.
Rolling circle amplification (RCA) solution
Introducing the complete system to produce DNA templates for IVT that uses the RCA method of isothermal amplification. Different from traditional plasmid DNA template production, the RCA method encompasses a less complex, quicker-to-perform process that is cell-free. The new method reduces the risks of contamination and further enables the potential for new types of RNA therapeutics.
TheraPure phi29 DNA polymerase
- High activity and fidelity
- Animal origin free (AOF) manufacturing process and composition
- Cost-effective transition to TheraPure GMP
TheraPure GMP dNTPs
- High purity
- Manufactured following ICH Q7 GMP guidelines
- Validated production and QC process
Accelerate your mRNA vaccine development and production
mRNA raw materials to start your production
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
Nucleotides
ATP, CTP, GTP, UTP
Modified nucleotides
N1-methylpseudo-UTP
In vitro transcription
Restriction enzymes
T7 RNA polymerase
Pyrophosphatase, inorganic
RNase inhibitor
DNase I
Proteinase K
mRNA modification
Capping systems
Poly(A) polymerase
2’-O-methyltransfrase
S-adenosyl methionine
TheraPure GMP and TheraPure 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 exceptional 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. To learn more, watch this quality tour video
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.
Quality tour for raw material of mRNA therapeutics manufacturing
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.