For further processing into medical devices, IVD and pharmaceutical products only. Others SP6 RNA Polymerase rec GMP grade SP6 RNA Polymerase, rec., GMP Grade, AOF 102 1584029687338397 Warranty LimitationIt 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. PID00000520 from SP6 bacteriophage, recombinant in E.coli, solution 09 959 513 103 9 959 513 103 09959513103 9959513103 09959513103 SP6 RNA Polymerase rec., GMP Grade, AOF SP6 RNA Polymerase rec., GMP Grade, AOF Reagents, kits 25 mL Not Available Will be supplied as 'SP6 RNA Polymerase, rec., GMP Grade, AOF'. Unit of measure is 'mL'. SP6 RNA Polymerase is one of the key enzymes for the in vitro synthesis of mRNA from a DNA template. en 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. en 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 qualityAnimal-Origin-Free process (AOF)Antibiotics-free processExtended testing for impuritiesTesting of Heavy Metals as contaminantRegulatory document support en Appearance: Clear, colorless solutionVolume Activity: ≥ 500 kU/mLUnit definition: One unit is defined as the enzyme activity which incorporates 1 nmol CMP in acid-precipitable RNA within 60 min at +37°CProtein (abs 280 nm): 1.8 – 2.2 mg/mlPurity (SDS-PAGE): ≥ 95 %Unspecific nucleases (up to 300 ng enzyme using MWM III-DNA; 16 h/37°C): Not detectableNicking activity (up to 300 ng enzyme using pBR 322-DNA; 16 h/37°C): Not detectableRNase activity ( up to 300 ng enzyme using MS II-RNA; 1 h/37°C): Not detectableProteases (50 μg/15 min/37°C): Not detectableExonucleases (using 1 μg): Not detectableEndotoxins: <5 EU/mLTotal Bioburden: <5 CFU/mLE.coli HC DNA ≤ 100 pg/mg protein: CorrespondsE.coli HC protein ≤ 50 ppm: CorrespondsHeavy metals (Ni, Co, V): ≤ 10 ppmStability: At -25°C to -15°C within specification range for 18 months from date of manufacture. en

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SP6 RNA Polymerase, rec., GMP Grade, AOF

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