Advancing your mRNA therapeutic from development to commercialization requires critical raw material because the quality of your ancillary materials can significantly impact the properties of your final mRNA molecules. That’s why we developed Thermo Scientific portfolio of TheraPure mRNA synthesis enzymes including T7 RNA polymerase, inorganic pyrophosphatase, and more. This way we can provide you with pharma grade, animal origin-free and TSE/BSE free enzymes with full traceability for your mRNA synthesis, as you move from development to commercialization.
Enabling a seamless transition
Changing raw materials in therapeutic development to manufacturing often creates significant costs and loss of time. Utilizing pharma grade reagents such as TheraPure enzymes at an early stage can help minimize your raw material risk.
Table 1. Comparison of TheraPure enzymes GMP-grade and Research/clinical development-grade by manufacturing details.
|TheraPure enzymes, GMP grade (single-use system manufacturing)||TheraPure enzymes, Research and clinical development grade (conventional manufacturing)|
TheraPure enzymes across the in vitro transcription (IVT) workflow
Browse Table 2 for the extended list of enzymes needed for in vitro transcription (IVT). Each of our TheraPure IVT enzymes undergo extensive safety and quality testing and are accompanied by appropriate documentation so you can transition your mRNA therapeutics from research to commercialization.
Table 2. TheraPure enzymes, mixes, and kits for mRNA synthesis.
|IVT mixes||T7 enzyme mix, AOF|
|Kits||Custom RNA kit|
* GMP grade, manufactured in single-use system.
Quality Control Specifications—reduce uncertainties in critical raw material
Thermo Fisher Scientific works to optimize the entire enzyme portfolio to meet fit-for-purpose standards. The specifications for IVT enzymes are determined by the intended use for further manufacturing therapeutics mRNA.
Table 3. QC requirements between TheraPure and catalog IVT enzymes.
|TheraPure enzymes||Catalog enzymes|
|GMP grade (single-use system manufacturing)||Research and clinical development grade (conventional manufacturing)||Research use only (RUO) IVT enzymes|
|Color and clarity||✓||N/A||N/A|
|Biological activity (function)||✓||✓||✓|
|Purity and impurities||✓||✓||N/A|
|Endodeoxyribonucleases (nicking activity)||✓||✓||✓|
|Exo-, endodeoxyribonucleases, phosphatases||✓||✓||✓|
|Residual host cell DNA||✓||✓||N/A|
|Residual host cell proteins||✓||✓||N/A|
Note: TheraPure enzymes, GMP-grade are mycoplasma free.
In an effort to help you maximize the potential of your mRNA synthesis and development, and simplify the transition to manufacturing and commercialization, we offer an extensive selection of TheraPure in vitro transcription (IVT) enzymes.
Table 4. TheraPure IVT enzyme portfolio with available activity concentrations. Where activity is not reported, please contact us for availability.
|Enzyme||GMP grade (single-use system manufacturing)||Research and clinical development grade (conventional manufacturing)|
|RE (Eam1104I)||20 U/µL||20 U/µL|
|RE (EcoRI)||Contact us for availability||10 U/µL|
|RE (LguI)||Contact us for availability||Contact us for availability|
|T7 RNA polymerase||200 U/µL||Available in 50, 100, and 200 U/µL|
|RNase inhibitor||40 U/µL||40 U/µL|
|Inorganic pyrophosphatase||0.1 U/µL||Available in 0.1 and 1 U/µL|
|DNase I||50 U/µL||Available in 2, 10, and 50 U/µL|
|DNase I, v2.0||Contact us for availability||Contact us for availability|
|Capping enzyme||Contact us for availability||10 U/µL|
|2’-O-methyltransferase||Contact us for availability||50 U/µL|
|Poly(A) polymerase||Contact us for availability||5 U/µL|
|Proteinase K||Contact us for availability||0.6 U/µL|
|T7 enzyme mix, AOF||Contact us for availability||Multiple concentrations|
|Custom RNA kit (A45795)||Contact us for availability||Custom concentration|
We know that not all IVT enzyme requirements are alike. We are committed to providing you with TheraPure reagents customized to your needs—quality enzymes you know and trust, personalized to your specifications.
- Add or remove components
- Change formulaton
- Custom QC tests
- Custom packaging options including size/volume, containers, labels, etc.
If you are interested in a custom TheraPure IVT enzyme or services, contact us
Assistance with ordering, order status, and invoices
Technical assistance for all TheraPure product inquiries and selections, troubleshooting, and technical questions
Business development manager
Help navigate regulatory processes, custom products, and service offering from research to commercialization