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T7 RNA Polymerase, GMP Grade

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Manual

Product Number: GMP-T701            Animal-free          Ampicillin-free

Shipping and Storage

At -20±5℃.

Description

As a biological macromolecule, mRNA can be synthesized on a large scale by in vitro transcription (IVT). T7 promoter is one of the most efficient promoters at present. Therefore, T7 RNA polymerase can be used for in vitro transcription to obtain more synthetic products. T7 RNA polymerase is a T7 promoter-specific, DNA-dependent, 5'→3' RNA polymerase from T7 bacteriophage. Usingdouble stranded DNA as the template, it transcribes RNA complementary to the single stranded DNA located at the downstream of T7promoter. T7 RNA polymerase has been commonly used for in vitro mRNA synthesis.

The polymerase is GMP Grade produced in E. coli. Our manufacturing processes are strictly controlled to ensure the end products free from host protein or nucleic acid contaminations and other impurities following the Pharmaceutical Manufacturing Guidelines. We guarantee the manufacturing and quality control comply with GMP regulation for tracking each and every step of the manufacturing process, including raw material sourcing.

This product has completed the DMF record of FDA and passed the HALAL certification.

Quality Elements

ElementStandard
Appearancetransparent liquid
Visible impuritiescomplying to regulation
pH value7.5-8.5
Active49kU/ml-51kU/ml
purity≥95%
Endonuclease residuesThe degradation of substrate was ≤10%
Exonuclease residuesThe degradation of substrate was ≤10%
RNase residuesThe degradation of substrate was ≤10%
Endotoxin residues<5EU/mg
Exogenous DNA residues≤100 pg/mg
Host protein residues≤50 ppm
MycoplasmaNegative
Heavy metal residues≤10 ppm

Annotation: ChP refers to the Pharmacopoeia of the People’s Republic of China.

Complying to following regulations

  1. ISO 9001:2015, certified facility.
  2. 《GMP Appendix – Cellular therapeutic product》National Medical Products Administration.
  3. 《The Pandect of Genetic Therapeutic Product for Human》Chinese Pharmacopoeia Commission.
  4. USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered 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.

Feature

Highly specific for T7 promoter, suitable for RNA in vitro synthesis.

Application

  1. Single stranded RNA synthesis
  2. RNA probe synthesis.
  3. siRNA precursor synthesis
  4. Precursor for RNA splicing preparation
  5. Capped RNA synthesis.

Examples

Fig: RNA transcription in vitro.

  1. From left to right, the quantity of T7 RNA Polymerase copies were 20U, 4U, 0.8U.
  2. DNA templates were segments of 2Kb.

Unit definition

At 37℃, pH8.0, within 1 hour, the amount of enzyme required that will incorporate 1nmol tritium labeled GMP into acid-insoluble material is defined as one unit of enzyme activity.

Storage buffer

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

Order

ComponentsVolume
T7 RNA Polymerase, GMP Grade (50U/μl)100μl
T7 RNA Polymerase, GMP Grade (50U/μl)1ml
T7 RNA Polymerase, GMP Grade (50U/μl)10ml
T7 RNA Polymerase, GMP Grade (50U/μl)50ml

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