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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 \"Pyrophosphatase, rec., GMP Grade, 20 ml\". Unit of measure is \"piece\". ", "Name": "CB - Order Information" }, { "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": "Manufactured under GMP (Good Manufacturing Practice) regulations. No animal-derived material is added in fermentation, purification and final formulation of this enzyme.", "Name": "Quality Control" }, { "Language": "en", "Value": "Pyrophosphatase hydrolyzes inorganic pyrophosphate that is generated during in vitro transcription reactions. By removing the unwanted pyrophosphate, the reaction equilibrium shifts to the product side increasing mRNA yield. The enzyme 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": "Pyrophosphatase improves the yield of in vitro mRNA synthesis.", "Name": "Positioning" }, { "Language": "en", "Value": "Pyrophosphatase is expressed with an N-terminal His-Tag.
EC Number: 3.6.1.1
Molecular weight: 34 kD
Cofactor requirement: Mg2+ for hydrolysis activity", "Name": "Properties" }, { "Language": "en", "Value": "Appearance: Clear, colorless to slightly yellowish solution
Volume activity: ≥ 600 U/mL
Unit definition: One unit of the Pyrophosphatase catalyzes the hydrolysis of 1 µmol inorganic pyrophosphate in 1 min at 25°C.
Protein (abs. 280nm): 1.8-2.2 mg/mL
Purity (SDS-PAGE): ≥ 95 %
Unspecific endonucleases (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
Bioburden: ≤ 10 CFU/mL
E. coli host cell DNA: ≤ 100 pg/mg Protein
E. coli host cell protein: ≤ 50 ppm
Heavy metals (Ni, Co, V): ≤ 10 ppm
Stability: At -15 to -25°C within specification range for 36 months from date of manufacture.", "Name": "Specification" } ] } } ] }

Pyrophosphatase, rec., GMP Grade, AOF

from yeast, expressed in E. coli, solution

pyrophosphatase
mrna

Improve your yield of mRNA
 

Pyrophosphatase is an essential enzyme for in vitro transcription of mRNA. By hydrolyzing inorganic pyrophosphate, it shifts the equilibrium of the mRNA synthesis reaction towards the formation of mRNA.

Designed fit-for-purpose to be used in the manufacture of mRNA for therapeutics and vaccines, Roche CustomBiotech Pyrophosphatase 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.

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

Overview

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Technical documents

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