- A Streptococcus pyogenes Cas9 (wt) protein, produced by recombinant DNA technology in E. coli for genome editing with CRISPR technology
- Cas9 protein forms a very stable RNP complex with the guide RNA (gRNA) component of the CRISPR/Cas9 system
- Incorporation of NLS aids delivery to the nucleus, increasing the editing efficiency and on-target cleavage.
- Engineered to deliver maximum ribonucleoprotein (RNP)-editing efficiency
- Manufactured in compliance with standards for Ancillary Materials for Cell, Gene and Tissue-Based Products and is subjected to stringent quality specifications
- Provided in a high-concentration and large-scale format for process development and clinical research applications
Additional features of CTS TrueCut Cas9 Protein include:
- Consistent high editing efficiency—superior CRISPR-Cas9 editing efficiency in all tested cell lines including primary immune cells (>90% editing in primary T cells)
- Higher stringency manufacturing—manufactured to meet the standards for Ancillary Materials for Cell, Gene, and Tissue-Based Products including USP <1043>, Ph.Eur. 5.2.12, and ISO 20399 -1, -2, -3, following the principles of 21 CFR Part 820 in a FDA-registered manufacturing site
- Aseptic manufacturing—entire process completed using single-use technology
- Extensive safety testing—includes sterility, endotoxin, mycoplasma, residual nucleic acids, and proteins
- Sterile filling—finished product is vialed in a Class A/B (Class 100 and ISO 5 equivalents) cleanroom
- Traceability documentation—COA, COO, Drug Master Files, and Regulatory Support Files are available
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