T7 RNA Polymerase - Pharmaceutical grade, high purity

Item Number

T406475

• Specifications & Purity: Pharmaceutical grade
• Storage Temp: Store at -20°C
• Shipped In: Ice chest + Ice pads
• Grade: pharmaceutical grade, PharmPure™

Product Description

T7 promoters are currently the most efficient type of promoters. Therefore, T7 RNA polymerase can be used for in vitro transcription to obtain more synthetic products. T7 RNA polymerase is also the RNA polymerase with the best comprehensive performance, which can realize large-scale industrialization. RNA production.

T7 RNA Polymerase (T7 RNA polymerase) is an enzyme encoded by bacteriophage T7 DNA. It is a DNA-dependent 5'→3' RNA polymerase that highly specifically recognizes the T7 promoter sequence. It contains polymerase and contains T7 promoter. The single-stranded or double-stranded DNA of the sequence is used as the template, and NTP is used as the substrate to synthesize the single-stranded downstream of the promoter as the substrate, and synthesize RNA that is complementary to the single-stranded DNA downstream of the promoter. T7 RNA polymerase is a key enzyme for in vitro transcription and production of therapeutic mRNA.

This product is a GMP-grade recombinant T7 RNA polymerase expressed by E. coli large-scale fermentation. It is produced with raw materials of pharmaceutical specifications and strictly controlled host protein residues and nucleic acid residues. Product production and quality management procedures that meet GMP specifications have been guaranteed and all original The accessories are traceable.

Quality requirements

Project	Standard	Method
Exterior	Clear liquid	Visual inspection
Visible foreign body	Compliance	Chinese Pharmacopoeia 2020 Edition Fourth Part 1 Lamp Inspection Method (General Rule 0904)
pH value	7.5-8.5	Chinese Pharmacopoeia 2020 Edition Part IV pH Determination Method (General Principle 0631)
Active	49KUml-51KU/ml	RNA transcription yield method
purity	≥95%	Chinese Pharmacopoeia 2020 Edition Part IV High Performance Liquid Chromatography (General Principle 0512)
Endonuclease residue	004-DNA degradation does not exceed 10%	Incubate 50U enzyme with 004-DNA.37C for 3h
Exonuclease residue	019 The degradation of HindⅢ DNA does not exceed 10%.	50U quotient and 019 HindⅢ DNA. Incubate at 37℃ for 3h
RNase residue	Degradation of 293-RNA does not exceed 10%	50U enzyme and 293-RNA. Incubate at 37°C for 1h
Bacterial endotoxin content	≤10 EU/mg	Chinese Pharmacopoeia 2020 Edition Fourth Gel Limit Test Method (General Rule 1143)
Exogenous DNA residue	≤100 pg/mg	Fluorescence quantitative PCR
Host protein residue	≤50 ppm	Chinese Pharmacopoeia 2020 Edition Part IV Method for the Determination of Bacterial Protein Residues (General Rule 3412)
Mycoplasma detection	Feminine	Mycoplasma detection kit
Heavy metal residue	≤10 ppm	Chinese Pharmacopoeia 2020 Edition Fourth Heavy Metal Inspection Method (General Principle 0821)

Follow the following specifications for production

1. ISO 9001:2015, certified facility.

2. "GMP Appendix-Cell Therapy Products" State Drug Administration. Cell Therapy Products" State Drug Administration.

3. "General Introduction to Human Gene Therapy-Chinese Pharmacopoeia 2020" National Pharmacopoeia Commission.

4. USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products are used as excipients in cell therapy, gene and tissue engineering products.

5. USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing

6. Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.

Features

It has a high degree of specificity for the T7 promoter and is used for the synthesis of RNA (including small RNA) in vitro.

Product Usage

1. Synthesize single-stranded RNA. 2. Synthesize highly specific RNA probes. 3. Synthesize siRNA precursor.

4. Make the precursor of RNA splicing reaction (RNA splicing). 5. Use cap analogs to synthesize capped RNA.

Preservation system

100 mM NaCl; 50 mM Tris-HCl (pH 7.9); 1 mM EDTA; 20 mM 2-mercaptoethanol; 0.1% Triton X-100; 50% (v/v) Glycerol.

Precautions

1. In order to effectively transcribe a specific region, it is recommended to cut the template DNA into blunt ends or 5'overhanging ends in advance in the downstream of the region.

2. Spermidine in the buffer may combine with nucleic acid to form insoluble matter. It is recommended to add template DNA at the end.