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"Product Grouping", "StructureNodeID": "02-0090", "StructureGroupPath": "CustomBiotech->Vaccine Testing", "StructureGroupName": "Vaccine Testing" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Modified UTP for the use in mRNA synthesis.", "Name": "Positioning" }, { "Language": "en", "Value": "Substituting UTP used for in vitro transcription reactions, this modified UTP generates a modified RNA with enhanced protein expression and reduced unwanted immunogenicity against the mRNA molecule itself. Its efficacy has been provenin the manufacture of COVID-19 vaccines.", "Name": "Applications" }, { "Language": "en", "Value": "Use this modified UTP in the synthesis of mRNA for therapeutics or vaccines. It is designed to meet the specific needs of the pharmaceutical industry (fit-for-purpose):
  • animal-origin-free (AOF)
  • free of ß-Lactam-antibiotics
  • extended testing for impurities
  • validated QC release methods and cleaning validation
  • supplied with supplementary documents for regulatory submissions.
", "Name": "Benefits" }, { "Language": "en", "Value": "Nomenclature: N1-methyl-pseudouridine-5'-triphosphate
CAS Number: 1428903-59-6 (free acid)
Formula: C10H17N2O15P(free acid)
Molecular weight: 498.2 D (free acid)", "Name": "Properties" }, { "Language": "en", "Value": "Appearance: Clear, colorless solution
pH value: 8.1–8.5
N1-Methyl-Pseudo-UTP (A271; pH 7.0 ε= 7.3 [L x mmol–1 x cm–1]): 100–110 mmol/L
N1-Methyl-Pseudo-UTP (HPLC): ≥ 97 area%
Identity (HPLC-MS): corresponds
DNases/RNases: Negative
Nicking activity: Negative
Functional transcription assay: Corresponds to specification
Proteases: not detectable
Exonucleases: not detectable
Endotoxins: ≤ 10 EU/mL
Bioburden: ≤ 10 CFU/mL
Heavy metals (Ni, Co, V): ≤ 10 ppm
Stability: At -15 to -25°C within specification range for 12 months.", "Name": "Specification" }, { "Language": "en", "Value": "Mat. no. 09188991103 will be supplied as \"N1-Methyl-Pseudo-UTP, Na salt, 100 mM\". Unit of measure is \"mL\".
Mat. no. 09522409103 will be supplied as \"N1-Methyl-Pseudo-UTP, Na salt, 100 mM, 1 mL\". Unit of measure is \"piece\".
 ", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Manufactured under ISO 134485:2016. QC-release makes use of an extended range of validated methods.", "Name": "Quality Control" } ] } } ] }

N1-Methyl-Pseudo-UTP, AOF

sodium salt, 100 mM, solution

mrna

A clean start in mRNA synthesis
 

Modified ribonucleotides enhance the expression and reduce the immunogenicity of mRNA. They are key to the success of therapeutic or vaccine mRNA.

Partially or completely replace UTP with this modified UTP to enhance the performance of modified mRNA. A fit-for-purpose reagent to manufacture mRNA for therapeutics and vaccines, Roche CustomBiotech N1-Methyl-Pseudo-UTP 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.

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.

The enzymes used in the synthesis process have been made without the use of ß-lactam antibiotics. 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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