GMP Salt Active GENIUS™ Nuclease is developed using ACROBiosystems' unique enzyme AI evolution platform, based on wild-type Serratia marcescens endonuclease. It maintains high specific activity, effectively degrading nucleic acids in any form across a broad salt concentration range (0-500 mM NaCl), particularly in high salt conditions up to 500 mM NaCl. This makes it ideal for nucleic acid removal in processes with higher salt concentrations.
The enzyme is a non-specific nuclease with high specific activity. It is capable of degrading single- and double-stranded nucleic acids in various forms (single-stranded, double-stranded, linear, circular, and supercoiled). It hydrolyzes internal phosphodiester bonds between nucleotides, producing 5'-phosphorylated oligonucleotides of 3-5 bases in length.
Features
- Manufactured and QC tested in a GMP-compliant facility
- Designed in accordance with ISO 9001:2015 and ISO 13485:2016 standards
- Made with animal-free materials
- FDA DMF filed
- Free from beta-lactam materials
- Consistent quality across batches
- Subjected to stringent quality control testing
- No animal-derived peptone or lactose used in the production process
Application
Nucleic acid removal from biologics, effective for samples containing 0-500 mM salt with 5-10 mM Mg++
- Clinical viral vector production for cell and gene therapy (CGT)
- Clinical viral vaccine production
- Other clinical development and production applications
Purity
- >95% as determined by SEC-HPLC
- >95% as determined by SDS-PAGE
Enzyme activity
＞250 U/μL
Host cell protein
<0.05 ng/µg of protein tested by ELISA
Protease activity
Negative
Sterility
Sterility testing was conducted using the membrane filtration method outlined in CP<1101>, USP<71>, and Eur. Ph. 2.6.1.
Mycoplasma
Negative
Endotoxin
Less than 10 EU/mg as determined by the LAL method.
Formulation
Provided as a 0.2 μm filtered solution in 25 mM Tris, 500 mM NaCl, 5 mM MgCl2, pH 7.5.
Shipping
The product is supplied and shipped with dry ice.
Storage
This product remains stable when stored under the following conditions:
- Upon receipt, the product must be stored at -20 °C or lower
- -20 °C for 5 years under sterile conditions.
ACRO quality management system
- Quality Advantages
- QMS（ISO, GMP）
- Quality Control Process
QC and assay protocol
SDS-PAGE
Image Credit: ACROBiosystems Inc
Coomassie Blue was used to stain the gel. According to Star Ribbon Pre-stained Protein Marker, the protein's purity is more than 95%.
SEC-HPLC
Image Credit: ACROBiosystems Inc
According to SEC-HPLC, GMP Salt Active GENIUSNuclease (Cat. No. GMP-NUES13) had a purity of over 95%.
Bioactivity
The specific activity of GMP Salt Active GENIUS™ Nuclease is measured under standard assay conditions. At a 500 mM salt concentration, the specific activity of GMP GENIUS Nuclease is greater than 4.3E+05 units/mg (QC tested). One unit digests sonicated salmon sperm DNA into acid-soluble oligonucleotides, resulting in a ΔA260 of 1.0 within 30 minutes at pH 8.0 and 37 °C. This corresponds approximately to the complete digestion of 37 μg of DNA.
Image Credit: ACROBiosystems Inc
GMP GENIUS Nuclease exhibits high specific activity.
Image Credit: ACROBiosystems Inc
The effect of Mg++ concentrations on Salt Active GENIUS™ Nuclease activity. The Nuclease needs around 5 mM Mg++ cations for optimal activity.
Bioactivity-Stability
Image Credit: ACROBiosystems Inc
The specific activity demonstrates that GMP Salt Active GENIUS™ Nuclease (Cat. No. GMP-NUSE13) maintains stability across different batches.
Image Credit: ACROBiosystems Inc
The specific activity also shows that GMP Salt Active GENIUS™ Nuclease (Cat. No. GMP-NUSE13) remains stable at 37 °C for 21 days.