GMP GENIUS™Nuclease
Catalog # GMP-NUES19Features

Enzyme Activity

Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory≥250 U/μL

Host Cell Protein<0.05 ng/µg of protein tested by ELISA.

FDA DMF filed
Animal-Free materials
Beta-lactam materials free
Batch-to-batch consistency
Stringent quality control tests
No animal derived peptone and lactose used in production process

Product Details

Protease Activity
Negative.

Sterility
The sterility testing was performed by membrane filtration method described in
CP<1101>, USP<71> and Eur. Ph. 2.6.1.

Mycoplasma
Negative.

GMP GENIUS™Nuclease is a tag-free recombinant form of Serratia marcescens
extracellular endonuclease produced in Escherichia coli using a proprietaryprocess 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 aEndotoxin
Less than 10 EU/mg by the LAL method.

Heavy Metals

non-specific nuclease with high specific activity, degrading single- and double-≤10 ppm.

stranded nucleic acids in any form (single stranded, double stranded, linear,Formulation

circular, and supercoiled). It hydrolyzes internal phosphodiester bonds present
between the nucleotides to 5’- phosphorylated oligonucleotides of 3-5 bases in

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

pH8.0.

Application

Contact us for customized product form or formulation.

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)

Shipping
This product is supplied and shipped with dry ice, please inquire the shippingcost.

• Other clinical development and production uses

Storage

Operating Conditions

This product is stable after storage at:

GMP GENIUS™Nuclease is functional between pH 6 and 10 (optimal at pH8 -The product MUST be stored at -20°C or lower upon receipt;

8.5) , and from 0°C to 50 °C (optimal at 37 °C - 45 °C). Mg2+ (1-2 mM) is-20°C for 5 years under sterile conditions.

required for enzyme activity.1 mM EDTA reduced the activity by 30% in thepresence of 1 mM MgCl2; 0.1 M EDTA eliminated all enzyme activity. In thepresence 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 theactivity 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.

Purity>95% as determined by SDS-PAGE.

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9/18/2024

GMP GENIUS™Nuclease
Catalog # GMP-NUES19>99% as determined by SEC-HPLC.

SDS-PAGE

SEC-HPLC

The gel was stained with Coomassie Blue. The purity of the protein is greater

The purity of GMP GENIUS™Nuclease (Cat. No. GMP-NUES19) was greaterthan 95%.

than 99% as determined by SEC-HPLC.

Bioactivity
Specific activity for GMP GENIUS Nuclease is measured under standard assay
conditions. The specific activity of GMP GENIUS Nuclease, is > 1.2 x 10^6unit/mg protein (QC tested). One unit will digest sonicated salmon sperm DNAto acid-soluble oligonucleotides equivalent to a ΔA260 of 1.0 in 30 min at pH
8.0 at 37 °C, which corresponds approximately to complete digestion of 37 μg
DNA,Note that 1 KU=1000 units.

GMP GENIUS Nuclease shows high specific activity.

The effect of Mg++ concentrations on GENIUS™Nuclease activity. The
Nuclease requires 1-2 mM Mg++ cations for optimal activity.

Bioactivity-Stability

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9/18/2024

GMP GENIUS™Nuclease
Catalog # GMP-NUES19

The specific activity shows that GMP GENIUS™Nuclease (Cat. No. GMP-

The specific activity shows that GMP GENIUS™Nuclease (Cat. No. GMP-

NUES19) is stable in different batches.

NUES19) is stable after 3 freeze-thaws.

MANUFACTURING SPECIFICATIONSACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter
5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell
Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary
Materials Present During the Production of Cellular Therapeutic Products.

ACROBiosystems Quality Management System Contents：
Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.
Animal-Free materials
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
Qualified personnel
Quality-related documents review and approve by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
Comprehensive regulatory support files
Request For Regulatory Support Files（RSF）

ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meetstringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:
SDS-PAGE
Protein content
Endotoxin level

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9/18/2024

GMP GENIUS™Nuclease
Catalog # GMP-NUES19

Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testing
Mycoplasma testingIn vitro virus assay
Batch-to-batch consistency

Clinical and Translational Updates

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9/18/2024