rdoe_global.search
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"OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "999", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0090", "StructureGroupPath": "CustomBiotech->Vaccine Testing", "StructureGroupName": "Vaccine Testing" } ] }, { "ProductID": "3.6.14.8.1.6", "BrandName": "Proteinase K, rec., PCR Grade, sol.", "ProductNameAddition": "from Titrirachium album, expressed in Pichia pastoris, solution", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "70-044-00", "StructureGroupPath": "Raw 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Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureGroupName": "CustomBiotech and LifeScience" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0136", "StructureGroupPath": "CustomBiotech->Molecular Raw Materials", "StructureGroupName": "Molecular Raw Materials" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "241-00", "StructureGroupPath": "Nucleic Acid Extraction and Purification", "StructureGroupName": "Nucleic Acid Extraction and Purification" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "130-00", "StructureGroupPath": "Sample Preparation", "StructureGroupName": "Sample Preparation" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0062", "StructureGroupPath": "CustomBiotech->mRNA Reagents", "StructureGroupName": "mRNA Reagents" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "520", "StructureGroupPath": "CustomBiotech", "StructureGroupName": "CustomBiotech" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0014", "StructureGroupPath": "CustomBiotech->Enzymes", "StructureGroupName": "Enzymes" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "180-00", "StructureGroupPath": "Manufacturing", "StructureGroupName": "Manufacturing" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "999", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "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.", "Country": "XG", "Code": "Positioning", "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.", "Country": "XG", "Code": "Applications", "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.
", "Country": "XG", "Code": "Benefits", "Name": "Benefits" }, { "Language": "en", "Value": "Nomenclature: N1-methyl-pseudouridine-5'-triphosphate
CAS Number: 1428903-59-6 (free acid)
Formula: C10H17N2O15P3 (free acid)
Molecular weight: 498.2 D (free acid)", "Country": "XG", "Code": "Properties", "Name": "Properties" }, { "Language": "en", "Value": "Appearance: Clear, colorless solution
pH value: 8.1–8.5 (25 °C ± 1 °C)
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): ≥ 98.5 area%
Identity (HPLC-MS): corresponds
DNases/RNases: not detectable
Nicking activity: not detectable
Functional transcription assay: Corresponds to specification
Proteases: not detectable
Exonucleases: not detectable
Endotoxins: ≤ 2 EU/mL
Bioburden: ≤ 5 CFU/mL
Heavy metals (Ni, V): ≤ 10 ppm
Stability: At -15 to -25°C within specification range for 18 months.", "Country": "XG", "Code": "Specification", "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\".
 ", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Manufactured under ISO 134485:2016. QC-release makes use of an extended range of validated methods.", "Country": "XG", "Code": "Quality Control", "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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Technical documents

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for certificates, method sheets (instructions for use), safety data sheets and software downloads
logo
ATP, GMP Grade sodium salt, 100 mM
logo
DNase I, rec., RNase-free, GMP Grade from bovine pancreas, expressed in Pichia pastoris, solution
cb
Restriction endonuclease Xba I, recombinant, AOF from Xanthomonas campestris pv. Badrii, expressed in E. coli, solution
cb
RNase Inhibitor, rec., GMP Grade, AOF from rat lung, expressed in E. coli, solution
logo
CTP, GMP Grade sodium salt, 100 mM
pyrophosphatase
Pyrophosphatase, rec., GMP Grade, AOF from yeast, expressed in E. coli, solution
logo
GTP, GMP Grade sodium salt, 100 mM
logo
UTP, GMP Grade sodium salt, 100 mM
logo
T7 RNA Polymerase, rec., GMP Grade, AOF from T7 bacteriophage, recombinant in E.coli, solution Designed fit-for-purpose to manufacture therapeutic mRNA Roche T7 RNA Polymerase provides versatility in your choice of nucleotides. Available in scale and quality from development to manufacturing. Learn more.
logo
Proteinase K, rec., PCR Grade, sol. from Titrirachium album, expressed in Pichia pastoris, solution
cb logo
SP6 RNA Polymerase, rec., AOF from SP6 bacteriophage, recombinant in E.coli, solution
Pseudo-UTP, AOF
Pseudo-UTP, AOF sodium salt, 100 mM, solution
N<sup>1</sup>-Methyl-Pseudo-UTP, GMP Grade, AOF
N1-Methyl-Pseudo-UTP, GMP Grade, AOF sodium salt, 100 mM, solution
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