animal-free, ampicillin-free

Description

Restriction endonucleases are a class of endonuclease that recognize specific deoxynucleotide sequences and cleave the phosphodiester bond between two deoxyribonucleotides at specific sites in each chain. BsaI derived from Bacillus Thermophilus, is a commonly used restriction endonuclease. BsaI recognizes the following sequence:

5’…GGTCTC(N)1↓…3’;

3’…CCAGAG(N)5↑…5’.

Then it functions DNA cleavage.

This product uses recombinant protein production technology to obtain restriction endonuclease BsaI. Applying pharmaceutical leveled adjuvant and material for production, strictly controlling host protein residues, nucleic acid residues and other impurities, we guarantee manufacture and quality control practice complying to GMP regulation, as well as all the materials traceable.

Specification

Test	Standard
Appearance	Clear and transparent solution
Visible Particles	Meet the specification
pH	7.0-8.0
Activity	10KU/ml-10.5KU/ml
Purity	≥95%
Endonuclease Residues	The degradation of substrate was ≤10%
Exonuclease Residues	The degradation of substrate was ≤10%
RNase Residues	The degradation of substrate was ≤10%
Bacterial Endotoxin Residues	≤10 EU/mg
Exogenous DNA Residues	≤10 pg/KU
Host-cell Protein Residues	≤50 ppm
Mycoplasma	Negative
Heavy Metal Residues	≤10 ppm

Production according to the following specifications

1. ISO 9001:2015, certified facility.

2. GMP appendix - 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.

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.

Unit Definition

At 37℃, pH 7.5, within 1 h, the amount of enzyme required for totally digestion 1μg λDNA (HindIII digestion, none Dcm methylation) is defined as one unit of enzyme activity.

Storage buffer

10mM Tris-HCl; 300mM NaCl; 1mM DTT; 0.1mM EDTA; 0.5mg/ml HAS; 50% Glycerol; pH 7.4 at 25℃.

Storage temperature

-20±5℃.

Package

Item	Quantity
BsaI, GMP Grade (10U/μl)	100μl

Reaction System (50μl)

Components	Quantity
10×BsaI Reaction Buffer, GMP Grade	5μl
Substrate DNA	1μg
BsaI, GMP Grade	1μl
RNase Free Water	Up to 50μl

Order

M062012

BsaI, GMP Grade

Animal-free, ampicillin-free

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