GMP GENIUS™ Nuclease is a tag-free recombinant form of Serratia marcescens extracellular endonuclease, produced in Escherichia coli through a proprietary process at ACROBiosystems. It functions optimally at low to physiological salt concentrations (0–200 mM NaCl). The enzyme exists as a homodimer, with each monomer having a molecular mass of approximately 30 kDa.
As a non-specific nuclease with high activity, it efficiently degrades nucleic acids in various forms, including single-stranded, double-stranded, linear, circular, and supercoiled structures. It hydrolyzes internal phosphodiester bonds between nucleotides, generating 5’-phosphorylated oligonucleotides ranging from 3 to 5 bases in length.
Features
- Developed following ISO 9001:2015 and ISO 13485:2016 standards
- Made with animal-free materials
- Produced and QC tested in a GMP-compliant facility
- FDA DMF filed
- Beta-lactam-free formulation
- Undergoes rigorous quality control testing
- Guaranteed batch-to-batch consistency
- Free from animal-derived peptone and lactose in the manufacturing process
Application
Optimized for nucleic acid removal in biologics, effective in samples with 0–200 mM salt and 2–10 mM Mg²⁺, making it ideal for:
- Clinical viral vaccine production
- Clinical viral vector manufacturing for cell and gene therapy (CGT)
- Other applications in clinical development and bioproduction
Operating conditions
GMP GENIUS™ Nuclease functions within a pH range of 6 to 10, with optimal activity between pH 8 and 8.5. It remains active at temperatures from 0 °C to 50 °C, with peak performance observed between 37 °C and 45 °C. The enzyme requires 1–2 mM Mg²⁺ for activity. Inhibition studies show that 1 mM EDTA reduces activity by 30% in the presence of 1 mM MgCl₂, while 0.1 M EDTA completely inhibits activity.
In 1 mM MgCl₂, enzyme activity decreases by 75% when exposed to 0.1 M CaCl₂ or 1 M NaCl. Under standard assay conditions, 1 mM iodoacetate does not affect the enzymatic rate, whereas 1 mM mercaptoethanol and maleic acid reduce activity by only 5–10%.
10 mM p-Chloromercurybenzoate completely inactivates the enzyme, while 0.64 M beta-mercaptoethanol in the presence of 2 M urea causes only partial inactivation. Interestingly, enzyme activity increases when exposed to 4 or 7 M urea.
Purity
- >99% as determined by SEC-HPLC
- >95% as determined by SDS-PAGE
Enzyme activity
≥250 U/μL
Host cell protein
ELISA shows <0.05 ng/µg of protein.
Protease activity
Negative
Sterility
Sterility testing was conducted using the membrane filtration method as outlined in CP <1101>, USP <71>, and Eur. Ph. 2.6.1.
Mycoplasma
Negative
Endotoxin
Endotoxin levels are less than 10 EU/mg, as determined by the LAL method
Heavy metals
≤10 ppm.
Formulation
The product is provided as a 0.2 μm filtered solution in 20 mM Tris, 20 mM NaCl, and 2 mM MgCl₂ at pH 8.0.
Shipping
It is supplied and shipped on dry ice.
Storage
This product is stable after storage at:
- -20 °C for 5 years under sterile conditions
- The enzyme should be stored at -20 °C or lower upon receipt
ACRO quality management system
- Quality Advantages
- QMS（ISO, GMP)
- Quality Control Process
QC and assay protocol
SDS-PAGE
Image Credit: ACROBiosystems Inc
The gel was stained with Coomassie Blue. The protein's purity exceeds 95%.
SEC-HPLC
Image Credit: ACROBiosystems Inc
The purity of GMP GENIUS™ Nuclease (Cat. No. GMP-NUES19) was further analyzed by SEC-HPLC, showing a purity level greater than 99%.
Bioactivity
The specific activity of GMP GENIUS™ Nuclease is determined under standard assay conditions and exceeds 1.2 × 10⁶ units per mg of protein (QC tested). One unit of the enzyme digests sonicated salmon sperm DNA into acid-soluble oligonucleotides, producing a ΔA260 of 1.0 within 30 minutes at pH 8.0 and 37 °C, equivalent to the complete digestion of approximately 37 μg of DNA. 1 KU equals 1,000 units.
Image Credit: ACROBiosystems Inc
GMP GENIUS™ Nuclease exhibits high specific activity.
Image Credit: ACROBiosystems Inc
The effect of Mg++ concentrations on GENIUS™ Nuclease activity. Optimal activity is observed at 1–2 mM Mg²⁺.
Bioactivity-Stability
Image Credit: ACROBiosystems Inc
The specific activity reveals that GMP GENIUS™ Nuclease (Cat. No. GMP-NUES19) is stable in different batches.
Image Credit: ACROBiosystems Inc
The specific activity demonstrates that GMP GENIUS™ Nuclease (Cat. No. GMP-NUES19) is stable after three freeze-thaws.