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"Product Grouping", "StructureNodeID": "02-0090", "StructureGroupPath": "CustomBiotech->Vaccine Testing", "StructureGroupName": "Vaccine Testing" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Will be supplied as \"T7 RNA Polymerase, rec., GMP Grade\". Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "T7 RNA Polymerase is the key enzyme for in vitro transcription of mRNA.", "Name": "Positioning" }, { "Language": "en", "Value": "T7 RNA Polymerase generates mRNA from double-stranded DNA templates carrying the T7 promotor sequence.
Previously used for many applications in R&D and some in Molecular Diagnostics, this key enzyme is now extensively used in the preparation of mRNA on commercial scale, for example, in the manufacture of COVID-19 vaccines. It efficiently incorporates standard or modified ribonucleoside triphosphates (NTPs) into mRNA transcripts.", "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": "Appearance: Clear, colorless solution
Volume Activity: ≥ 1000 kU/mL
Unit definition: One unit is defined as the enzyme activity which incorporates 1 nmol CMP in acid-precipitable RNA within 60 min at +37°C.
Protein (abs 280nm): 0.8-1.2 mg/mL
Purity (SDS-PAGE) ≥ 95 %
Unspecific nucleases (up to 300 ng enzyme using MWM III-DNA; 16 h/37°C): Not detectable
Nicking activity (up to 300 ng enzyme using pBR 322-DNA; 16 h/37°C): Not detectable
RNase activity ( up to 300 ng enzyme using MS II-RNA; 1 h/37°C): Not detectable
Proteases (50 μg/15 min/37°C): Not detectable
Exonucleases (using 1 μg): Not detectable
Endotoxins: ≤ 10 EU/mL
Total Bioburden: ≤ 10 CFU/mL
E.coli HC DNA ≤ 100 pg/mg protein: Corresponds
E.coli HC protein ≤ 50 ppm: Corresponds
Heavy metals (Ni, Co, V): ≤ 10 ppm
Stability: At -25°C to -15°C within specification range for 18 months from date of manufacture.", "Name": "Specification" }, { "Language": "en", "Value": "EC Number: 2.7.7.6
Molecular weight: 98 kD
Cofactor requirement: Mg2+ for mRNA synthesis
T7 promoter sequence required", "Name": "Properties" } ] } } ] }

T7 RNA Polymerase, rec., GMP Grade, AOF

from T7 bacteriophage, recombinant in E.coli, solution

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mrna

A perfect start in mRNA synthesis
 

T7 RNA Polymerase is the key enzyme for in vitro transcription of mRNA.
Fit-for-purpose to manufacture mRNA for therapeutics and vaccines, Roche CustomBiotech T7 RNA Polymerase 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, noanimal-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.

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Overview

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Technical documents

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