Research material available now.
cGMP NLS-SpCas9-NLS Nuclease Solution coming soon.

Akron’s recombinant NLS-SpCas9-NLS (Cas9) Nuclease Solution is manufactured following all relevant cGMP guidelines for ancillary materials. It is purified using pharmaceutical techniques without the use of histidine tags and nickel columns. Akron’s Cas9 Nuclease is a single-chain, 162 kDa, non-glycosylated DNA endonuclease expressed in E. coli. The amino acid sequence comes from Streptococcus pyogenes, and the protein structure has been altered by the addition of a nuclear localization sequence (NLS) to both the N- and C- terminals of the protein, ensuring it is effectively imported into the cell nucleus.

Active Substance

• NLS sequences added to both the N- and C- terminal
• Effective site-directed nuclease activity
• Carrier protein-free formulation

Manufacturing

• Tag-free pharmaceutical processing
• Sterile filtration and aseptic filling
• Animal free expression system with E. coli host

Quality

• Relevant cGMP guidelines used in manufacture, testing, and release
• USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• EP 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
• ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
• ISO/TS 20399-1-3:2018, Biotechnology – Ancillary Materials Present During the Production of Cellular Therapeutic Products

Stability

• Store at -80 °C
• Keep out of light and avoid repeated freeze-thaw cycles
• Ships with Dry Ice

For Use Statement

For research use or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.

DISCLAIMER: Currently available as Catalog # PD1019, for research use only, not for further manufacturing. cGMP material available in 2023 as Catalog # AR1054.