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.
• NLS sequences added to both the N- and C- terminal
• Effective site-directed nuclease activity
• Carrier protein-free formulation
• Tag-free pharmaceutical processing
• Sterile filtration and aseptic filling
• Animal free expression system with E. coli host
• 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
• Under long-term stability program
• Store at -80 °C
• Keep out of light and avoid repeated freeze-thaw cycles
• Ships with Dry Ice
Final cGMP product: 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 Q3 2022 as Catalog # AR1054.
• Appearance - (Visual Inspection)
• Protein Content - (UV Spectrophotometry)
• Purity - (RP-HPLC)
• Residual Rnase - (Western Blot)
• Residual Dnase - (Non-reducing SDS-PAGE)
• Residual Host Protein - (Reducing SDS-PAGE)
• Residual Host DNA - (ELISA)
• Activity, in vitro - (Cas9-mediated cleavage of reference DNA)
• Activity, cellular editing - (Cas9 Cellular Editing Assay)
• Bacterial Endotoxins - (USP <85> / EP 2.6.14)
• Mycoplasma - (USP <63> / EP 2.6.7)
• Sterility - (USP <71> / EP 2.6.1)
DISCLAIMER: Release testing listed above is for final cGMP product (Cat # AR1054). Currently available as Catalog # PD1019, for research use only, not for further manufacturing.
1. Under what conditions should Akron’s Cas9 Nuclease Solution be stored?
Cas9 Nuclease should be stored at -80 ºC.
2. What is the shelf life of Akron's Cas9 Nuclease Solution?
Akron’s Cas9 nuclease solution is currently under a long-term stability program.
3. Can the Akron Cas9 Nuclease undergo multiple freeze-thaw cycles?
Please avoid multiple freeze-thaw cycles.
4. When does Akron expects to offer Cas9 Nuclease as a cGMP product?
Akron expects to launch a cGMP Cas9 Nuclease product in Q3 of 2022, available as Catalog # AR1054. Please contact us for details and updates. The currently available PD1019 product is for research use only.
cGMP Solution (1 mg) Cat. # AR1054
RUO Solution (1 mg) Cat. # PD1019