SP6 RNA Polymerase, rec., GMP Grade, AOF

SP6 RNA Polymerase is one of the key enzymes for the in vitro synthesis of mRNA from a DNA template.

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.

 

GMP Grade quality

Animal-Origin-Free process (AOF)

Antibiotics-free process

Extended testing for impurities

Testing of Heavy Metals as contaminant

Regulatory document support

Application

SP6 RNA Polymerase transcribes RNA from double-stranded DNA templates that are downstream from an SP6 promoter. Roche SP6 is a proven enzyme in many R&D and Molecular Diagnostics applications. This key enzyme is now extensively used also in the preparation of mRNA on commercial scale, for example, in the manufacturing of mRNA vaccines and therapeutics. It efficiently incorporates standard or modified ribonucleoside triphosphates (NTPs) into mRNA transcripts.

Properties

EC Number: 2.7.7.6

Molecular weight: 98.6 kDa

Cofactor requirement: Mg2+ for RNA synthesis

SP6 promoter sequence required

Specifications

Appearance: Clear, colorless solution

Volume Activity: ≥ 500 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 280 nm): 1.8 – 2.2 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: <5 EU/mL

Total Bioburden: <5 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 18 months from date of manufacture.

Regulatory Disclaimer

For further processing into medical devices, IVD and pharmaceutical products only.

 

License Disclaimer / Warranty Limitation

Warranty Limitation

 

It is the sole responsibility of the customer to determine the suitability of all raw materials, products and components in order to ensure that the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements. Roche makes no representations or warranties of any kind regarding the Product, express or implied, other than those expressly set forth in the terms and conditions of sale (if any), and disclaims all implied or statutory warranties including warranty of merchantability and fitness for a particular purpose.