Pseudo-UTP, AOF

Use this modified UTP for 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)

ß-Lactam-antibiotic free

extended testing for impurities

validated QC release methods and cleaning validation

supplied with supplementary documents for regulatory submissions

Application

This modified UTP can replace UTP in in-vitro-transcription reactions, e.g. for manufacturing mRNA therapeutics and vaccines. This RNA modification provides enhanced protein expression and reduced unwanted immunogenicity against the mRNA molecule itself. It represents an alternative to N1-Methyl-Pseudo-UTP which has proven its efficacy in Covid-19 vaccines.

Properties

Nomenclature: Pseudouridine-5'-triphosphate

CAS Number: 1175-34-4 (free acid)

Formula: C9H15N2O15P3 (free acid)

Molecular weight: 484.1 D (free acid)

Specifications

Appearance: Clear, colorless solution

pH value: 8.1–8.5

Pseudo-UTP (A262; pH 7.0 ε= 7.5 [L x mmol-1 x cm-1]): 100–110 mmol/L

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: ≤ 2 EU/mL

Bioburden: ≤ 5 CFU/mL

Heavy metals (Ni, V): ≤ 10 ppm

Stability: At -15 to -25°C within specification range for 12 months.

Regulatory Disclaimer

For further processing only.