T7 RNA Polymerase, 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

T7 RNA Polymerase generates mRNA from double-stranded DNA templates carrying the T7 promotor sequence.

Previously used for many applications in R&D and some in Molecular Diagnostics, this key enzyme is now extensively used in the preparation of mRNA on commercial scale, for example, in the manufacture of COVID-19 vaccines. It efficiently incorporates standard or modified ribonucleoside triphosphates (NTPs) into mRNA transcripts.

Properties

EC Number: 2.7.7.6

Molecular weight: 98 kD

Cofactor requirement: Mg2+ for mRNA synthesis

T7 promoter sequence required

Specifications

Appearance: Clear, colorless solution

Volume Activity: ≥ 1000 kU/mL

Unit definition: One unit is defined as the enzyme activity which incorporates 1 nmol CMP in acid-precipitable RNA within 60 min at +37°C.

Protein (abs 280nm): 0.8-1.2 mg/mL

Purity (SDS-PAGE) ≥ 95 %

Unspecific nucleases (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

Total Bioburden: ≤ 10 CFU/mL

E.coli HC DNA ≤ 100 pg/mg protein: Corresponds

E.coli HC protein ≤ 50 ppm: Corresponds

Heavy metals (Ni, Co, V): ≤ 10 ppm

Stability: At -25°C to -15°C within specification range for 24 months from date of manufacture.

Regulatory Disclaimer

For further processing only.