Thermo Fisher, EO038SKB002C, TheraPure™ GMP RNase Inhibitor (40 U/μL)

80 kU Thermo Scientific TheraPure GMP* RNase Inhibitor is manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation package. It is designed to prevent RNA degradation during development and manufacturing of mRNA therapeutics. As a potent noncompetitive inhibitor of RNases A, B, and C, it allows the newly synthesized RNA of in vitro transcription to remain intact.
Designed for process development and manufacturingTheraPure GMP RNase inhibitor helps accelerate mRNA vaccine and therapeutics production from preclinical development to commercialization by providing:Quality—meet critical product quality needs to help accelerate therapeutic development and manufacturingMinimal risk—helps reduce risks in developing therapeutics by utilizing proven productsTechnical partnership—partner with expert product and technical supportSecure and consistent supply—count on a secure and stable supply of product at a global scaleComprehensive quality systemTheraPure GMP RNase inhibitor is supported by a extensive quality system and documentation including:Manufactured to relevant ICH Q7 GMP guidelinesAnimal-origin free (AOF) manufacturing processes, materials, and facilitiesValidated manufacturing processes and analytical test methodsComprehensive impurity profilesVerified compendial assays where applicableProduct stability dataTested by analytical methods following ICH Q2 guidelines whenever possibleDrug master file (DMF)Enzyme activityOne unit is the amount of protein required to reduce the activity of 5 ng of RNase A by 50%.
For additional TheraPure GMP products or customization, please visit www.
thermofisher.
cn/therapure.*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.
Biological Activity: RNase Inhibitor
Color: Transparent
Compatible Buffer: 20 mM Tris-HCl, pH 8, 50 mM KCl, 0.
5 mM EDTA, 8 mM DTT, 50% (v/v) glycerol
Expression System: E. coli
For Use With (Application): In VitroTranscription
Mass: 52 kDa
Product Type: RNase Inhibitor
Purity: ≥95%
Quantity: 80 kU
Source: E. coli
Concentration: 40 U/μL
Enzyme: RNase Inhibitor
Form: Liquid
Product Line: TheraPure™ GMP
Research Category: Drug Development
Sensitive to Heat Inactivation: No
pH: 7.
6 to 8.
4
Unit Size: Each