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| Product Name | Cas9 Nuclease, GMP Grade (10 mg/mL) |
| Catalog No. | IVDRM-0588 |
| Description | A wild-type Cas9 from Streptococcus pyogenes, an RNA-guided endonuclease that cleaves double stranded DNA specifically, with the cut three bases upstream of the NGG PAM. This GMP grade preparation is codon-optimised with a nuclear localisation signal and expressed recombinantly in E. coli, giving high editing efficiency for modifying cells such as haematopoietic stem cells and T cells and for molecular diagnostics aimed at pathogen detection. Manufacturing and quality management follow GMP practice with tight control of key quality attributes including host protein and host nucleic acid residue, which supports stable performance between batches. In vitro cleavage activity is at least 98%, host DNA residue is below 3 ng/mL and host protein residue below 0.1 ppm. |
| Intended Use | Cellular gene modification of haematopoietic stem cells and T cells and molecular diagnostic pathogen detection |
| Principle / Technology | RNA-guided cleavage of double stranded DNA three bases upstream of the NGG PAM |
| Sample Type | Cells for gene modification and pathogen nucleic acid targets in diagnostics |
| Specificity | In vitro cleavage activity at least 98%; cut site three bases upstream of the PAM |
| Reaction Conditions / Protocol | Deliver as a ribonucleoprotein complex or expressed from a suitable vector for cell modification |
| Storage Conditions | -25 to -15°C |
| Shelf Life | 1 year |
| Package Specifications | 100 ug; 500 ug; 1 mg |
| Quality Control | Host DNA below 3 ng/mL; host protein below 0.1 ppm; mycoplasma negative; endonuclease, exonuclease, RNase and phosphatase negative |
| Key Features | GMP compliant manufacturing with controlled host residue; codon-optimised with a nuclear localisation signal |
| Purity | Greater than or equal to 95% |
| Concentration | 10 to 12 mg/mL |
| Source / Origin | Streptococcus pyogenes |
| Regulatory / Compliance | GMP grade |
| Readouts / Downstream Assays | In vitro cleavage assay and gene knockout efficiency in cells |
For in vitro diagnostic use.
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