TheraPure mRNA Synthesis Reagents

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)
Facilities	Separate HVAC for upstream and downstream facilities Qualified cleanrooms Upstream—cleanroom class D Downstream purification /formulation—cleanroom class C Product filling under class A (LAF unit) Animal origin-free (AOF) and beta-lactam-free environment	HVAC systems for downstream facilities Qualified cleanrooms Upstream—standard laboratories Downstream purification/formulation—cleanroom class D Shared processes based on animal origin and beta-lactam
Equipment	Closed single-use systems (fermenters, bags, tubing) Dedicated TFF membranes, purification resins	Shared upstream and downstream equipment (>300 different products manufactured per year) Buffer exchange in open containers using standard dialysis Dedicated multiple-use resins
Process	Inter-connected flow processes, vertically integrated layout Quality Control and In Process Control (IPC) testing QC and manufacturing validated for each product	Open and non-inter-connected processes QC and manufacturing validated for product families
Materials	Pharma grade, AOF, full traceability	Molecular biology grade (AOF for AOF products only)
Host	E. coli Yeast	E. coli
Strain/plasmid	Qualified and characterized MCB/WCB Optimized high level extracellular expression	Low-efficiency expression system, intracellular expression
Fermentation media/scale	AOF rich semi-synthetic media Single-use fermentation vessels	Steel tank, shared equipment fermentation Standard complex media
Clarification	Optimized clarification process Filtration closed process	Open cell disruption process, centrifugation
Purification	Single-use columns and resins	Multi-use columns and resins
Documents provided	Regulatory support documentation available	Not available

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.


Stand-alone products	Platinum SuperFi II DNA polymerase Restriction enzymes, TheraPure Eam1104I TheraPure* EcoRI TheraPure	T7 RNA polymerase, TheraPure* RNase inhibitor, TheraPure* Inorganic pyrophosphatase, TheraPure* DNase I, TheraPure*	Capping: Capping enzyme, TheraPure 2’-O-methyltransferase, TheraPure Poly(A) tailing: Poly(A) polymerase, TheraPure Ribonuclease inhibitor, TheraPure*	Proteinase K TheraPure*
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
Application Requirements	GMP grade (single-use system manufacturing)	Research and clinical development grade (conventional manufacturing)	Research use only (RUO) IVT enzymes
Identity	✓	N/A	N/A
Color and clarity	✓	N/A	N/A
pH	✓	N/A	N/A
Concentration	✓	✓	✓
Biological activity (function)	✓	✓	✓
Specific activity	✓	✓	N/A
Purity and impurities	✓	✓	N/A
Bacterial endotoxins	✓	✓	N/A
Endodeoxyribonucleases (nicking activity)	✓	✓	✓
Exo-, endodeoxyribonucleases, phosphatases	✓	✓	✓
RNases	✓	✓	✓
Residual host cell DNA	✓	✓	N/A
Residual host cell proteins	✓	✓	N/A
Microbial enumeration	✓	✓	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.

	TheraPure Enzymes
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

Customization capabilities

Experienced supplier of IVT reagents for your mRNA therapeutics development

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.