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.
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.
In vitro transcription
Restriction enzymes
T7 RNA polymerase
Pyrophosphatase, inorganic
RNase inhibitor
DNase I
Proteinase K
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 attribute | Standard | TheraPure | TheraPure Plus |
|---|---|---|---|
| Large scale production (grams to kilograms of mRNA) | No | Yes | Yes |
| AOF production process and raw materials (TSE-/BSE-free) | Limited (as specified) | Yes | Yes |
| Regulatory support documents available | No | Limited (TSE/BSE, COO, COA only) | Yes |
| Documentation follows ICH Q7 GMP guidelines | No | No | Yes |
| Validated product specific process and analytical methods | No | No | Yes |
| SKU specific product stability | No | No (Product family only) | Yes |
| Animal origin-free manufacturing equipment | No | No | Yes |
| β-lactam-free manufacturing facility | No | No | Yes |
| Melamine statement | No | No | Yes |
| Nitrosamine statement | No | No | Yes |
| Impurity profile | No | No | Yes |
| Material safety risk assessment (including latex and antibiotic use) | No | No | 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.
TheraPure product portfolios for mRNA production
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
| Nucleotides | Modified 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 |
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 enzymes | In vitro transcription | Post in vitro transcription clean up |
|---|---|---|
| EcoRI Eam1104I Lgul | T7 RNA polymerase Pyrophosphatase, inorganic RNAse inhibitor 5X transcription buffer | DNase I Proteinase K |
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 capping | mRNA tailing |
|---|---|
| Vaccinia capping enzyme Vaccinia Cap 2’-O-Methyltransferase S-adenosyl-methionine (SAM) 10X capping buffer | Poly(A) polymerase |
