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"Product Grouping", "StructureNodeID": "02-0090", "StructureGroupPath": "CustomBiotech->Vaccine Testing", "StructureGroupName": "Vaccine Testing" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "RNase Inhibitor protects RNA from RNases, be it in molecular diagnostics assays or during in vitro mRNA synthesis for therapeutics and vaccines.", "Name": "Positioning" }, { "Language": "en", "Value": "RNase Inhibitor boosts the performance of RNA-based applications. The protein effectively blocks ubiquitious RNases, thereby enhancing the sensitivity of RNA-based molecular diagnostic assays or protecting mRNA synthesized by in vitro transcription.
RNase Inhibitor is part of every preparative mRNA synthesis from lab-scale to industrial scale, for example in the synthesis of COVID-19 vaccines.", "Name": "Applications" }, { "Language": "en", "Value": "Use the enzyme in the synthesis of mRNA for therapeutics or vaccines. It is designed to meet specific needs of the pharmaceutical industry (fit-for-purpose):
  • animal-origin-free (AOF)
  • free of antibiotics
  • extended testing for impurities
  • manufactured under GMP
  • supplied with supplementary documents for regulatory submissions.
", "Name": "Benefits" }, { "Language": "en", "Value": "RNase Inhibitor is expressed with an N-terminal His-Tag.
CAS Number: 142298-75-7
Molecular weight: 50 kD", "Name": "Properties" }, { "Language": "en", "Value": "Appearance: Clear, colorless solution
Volume activity (according to Blackburn by inhibition of the hydrolysis of cCMP by RNAse A): > 40 kU/mL
Unit definition: One unit of RNase Inhibitor activity is defined as the amount which inhibits 50% of the activity of 5 ng RNase A.
Specific activity: > 80 kU/mg protein
Purity (SDS PAGE): > 95%
Unspecific nucleases (up to 400 U using MWM III-DNA/1 h/37°C): Not detectable.
Nicking activity (up to 400 U using pBR 322-DNA/1 h/37°C): Not detectable.
RNase activity (up to 400 U using MS 2-RNA/1 h/37°C): Not detectable
RNase activity after thermal inactivation (10 min/65°C): Not detectable up to 400 U using MS 2-RNA/1 h/37°C
Performance test on LightCycler® (PBGD system): Corresponds to specification
Endotoxins: ≤ 10 EU/mL
Bioburden: ≤ 10 CFU/mL
E.coli HC DNA: ≤ 100 pg/mg protein
E.coli HC protein: ≤ 50 ppm
Heavy metals (Ni, Co, V): ≤ 10 ppm
Proteases (50 μg/15 min/37°C): Not detectable
Stability: At -15 to -25°C within specification range for 18 months from date of manufacture.", "Name": "Specification" }, { "Language": "en", "Value": "09537589103:
Will be supplied as \"RNase Inhibitor, rec., GMP Grade, AOF, 2 MU\". Unit of measure is \"piece\".
09537643103:
Will be supplied as \"RNase Inhibitor, rec., GMP Grade, AOF, 100 kU\". Unit of measure is \"piece\".
 ", "Name": "CB - Order Information" } ] } } ] }

RNase Inhibitor, rec., GMP Grade, AOF

from rat lung, expressed in E. coli, solution

cb
mrna

Protect (m)RNA
 

RNase Inhibitor is essential whenever RNA needs protection from ubiquitous RNases. Designed as a fit-for-purpose reagent to manufacture mRNA for therapeutics and vaccines, or as a component for RNA-based molecular diagnostic assays, Roche CustomBiotech RNase Inhibitor provides the performance, quality, and scale you need.

We have designed our manufacturing process from the master cell bank to final QC-release to exclude or minimize potential contaminants, thereby reducing overall process risk and simplifying procedures for regulatory approval.

Produced using validated manufacturing and cleaning processes up to the final filling step and released under stringent final QC checks. Know that you are getting consistent quality every time.

From the generation of the master cell bank to the final filling, no animal-derived materials are used in the process. This greatly simplifies your risk analysis.

Our proprietary E. coli strain eliminates the need for antibiotics during fermentation. Therefore, allergic reactions to antibiotics is not a factor in your overall risk analysis.

Tested during final QC-release for the absence of impurities such as nucleases, host-cell DNA and protein, bioburden, heavy metals, or endotoxins. Work with an enzyme at peak performance that poses no risk to downstream processing.

We work with you to provide the necessary technical documents for your regulatory submissions.

Changing reagent quality between pre-clinical development and commercialization poses a risk. Secure your processes by using the best available quality from the start.

Reach out to your regional CustomBiotech representative for more information
Contact us

Overview

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Technical documents

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