GMP GENIUS™Nuclease

GMP GENIUS™Nuclease is a tag-free recombinant form of Serratia marcescens extracellular endonuclease produced in Escherichia coli using a proprietary process at ACRObiosystems. GMP GENIUS™Nuclease performs optimally at low and physiological salt concentrations (0-200 mM NaCl). The product is a homodimer with monomer molecular masses of about 30 kDa. The enzyme is a non-specific nuclease with high specific activity, degrading single- and double-stranded nucleic acids in any form (single stranded, double stranded, linear, circular, and supercoiled). It hydrolyzes internal phosphodiester bonds present between the nucleotides to 5’- phosphorylated oligonucleotides of 3-5 bases in length.

• Quality Assurance: Global QMS with comprehensive and stringent QC release criteria.
• End-to-End GMP Compliance: Full manufacturing and QC under a cGMP system.
• Comprehensive Control of Adventitious Agents: Stringent biosafety from cell banks to final release.
• Comprehensive Regulatory Support: Includes RSF and DMF to meet global requirements.
• Resilient Supply Chain: Intelligent modular facilities ensure a stable global supply.
• Professional Support: Extensive manufacturing and application expertise to accelerate development.

Elimination of nucleic acids from biologics, optimal for samples with 0-200 mM salt in presence of 2-10 mM Mg++
• clinical viral vaccine production
• clinical viral vector production for cell and gene therapy (CGT)
• Other clinical development and production uses

GMP GENIUS™Nuclease is functional between pH 6 and 10 (optimal at pH8 - 8.5) , and from 0°C to 50 °C (optimal at 37 °C - 45 °C). Mg2+ (1-2 mM) is required for enzyme activity.1 mM EDTA reduced the activity by 30% in the presence of 1 mM MgCl2; 0.1 M EDTA eliminated all enzyme activity. In the presence of 1 mM MgCl2, enzyme levels were reduced 75% by 0.1 M CaCl2 or 1 M NaCl. Under standard assay conditions, 1 mM iodoacetate had no effect on the enzymatic rate, whereas 1 mM mercaptoethanol and maleic acid reduced the activity by only 5 to 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 of the enzyme. 4 or 7 M Urea increases the enzyme activity.

>95% as determined by SDS-PAGE.

>99% as determined by SEC-HPLC.

≥250 U/μL

<0.05 ng/µg of protein tested by ELISA.

Negative

Sterility testing was performed using the membrane filtration method in compliance with USP <71> and Ph. Eur. 2.6.1.

Negative

Less than 10 EU/mg, tested by the LAL method in compliance with USP <85> and Ph. Eur. 2.6.14.

≤10 ppm.

Supplied as 0.2 μm filtered solution in 20 mM Tris, 20 mM NaCl, 2 mM MgCl2, pH8.0.

Contact us for customized product form or formulation.

2R (13 mm neck finish) for 100 KU; 6R (20 mm neck finish) for 500 KU

This product is supplied and shipped on dry ice.

• The product MUST be stored at -20°C or lower upon receipt;
• -20°C for 5 years under sterile conditions.