Pyrophosphatase, rec., GMP Grade, AOF

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.

Application

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.

Properties

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

Specifications

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.

Regulatory Disclaimer

For further processing only.