TheraPure mRNA Synthesis Enzymes

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.

 Workflow for in vitro transcription using TheraPure enzymes
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 mixesT7 enzyme mix, AOF
KitsCustom 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 enzymesCatalog enzymes
Application


Requirements		GMP grade (single-use system manufacturing)Research and clinical development grade (conventional manufacturing)Research use only (RUO) IVT enzymes
Identity✓N/AN/A
Color and clarity✓N/AN/A
pH✓N/AN/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
EnzymeGMP grade (single-use system manufacturing)Research and clinical development grade (conventional manufacturing)
RE (Eam1104I)20 U/µL20 U/µL
RE (EcoRI)Contact us for availability10 U/µL
RE (LguI)Contact us for availabilityContact us for availability
T7 RNA polymerase200 U/µLAvailable in 50, 100, and 200 U/µL
RNase inhibitor40 U/µL40 U/µL
Inorganic pyrophosphatase0.1 U/µLAvailable in 0.1 and 1 U/µL
DNase I50 U/µLAvailable in 2, 10, and 50 U/µL
DNase I, v2.0Contact us for availabilityContact us for availability
Capping enzymeContact us for availability10 U/µL
2’-O-methyltransferaseContact us for availability50 U/µL
Poly(A) polymeraseContact us for availability5 U/µL
Proteinase KContact us for availability0.6 U/µL
T7 enzyme mix, AOFContact us for availabilityMultiple concentrations
Custom RNA kit (A45795)Contact us for availabilityCustom 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.

  • 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

Related areas

mRNA purification solution   |   Gene therapy research   |   OEM and commercial supply   |   In vitro transcription

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