- Designed under ISO 9001:2015 and ISO 13485:2016
- Manufactured and QC tested under a GMP compliance factory
- Animal-Free materials
- Batch-to-batch consistency
- Stringent quality control tests
- No animal derived peptone and lactose used in production process
GMP GENIUS?Nuclease DMF Filed is a tag free recombinant form of Serratia marcescens extracellular endonuclease produced in Escherichia coli cells using a proprietary process at ACRObiosystems. GMP GENIUSNuclease DMF Filed is a homodimer with monomer molecular masses about 30 kDa with an isoelectric point (pI) at pH 6.85. The enzyme is a non-specific nuclease with high specific activity, which degrades both 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.
Predicted N-terminus: Met
Elimination of nucleic acids from biologics
- clinical viral vaccine production
- clinical viral vector production for cell and gene therapy（CGT）
- Other clinical development and production uses
宿主蛋白残留（Host Cell Protein）
<0.05ng/ug of protein tested by ELISA.
GMP GENIUS?Nuclease DMF Filed 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.
Less than 0.01 EU per μg by the LAL method.
The sterility testing was performed by membrane filtration method.
≥95% as determined by SDS-PAGE.
≥99% as determined by SEC-HPLC.
Please contact us for detailed information.
Contact us for customized product form or formulation.
This product is supplied and shipped with dry ice, please inquire the shipping cost.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
- The product MUST be stored at -20°C or lower upon receipt;
- -20°C for 24 months under sterile conditions.
GMP GENIUSNuclease on SDS-PAGE under condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.
The purity of GMP GENIUSNuclease (Cat.No.GMP-NUES19) was greater than 99% as determined by SEC-HPLC.
Specific activity for GMP GENIUS Nuclease is measured under standard assay conditions. The specific activity of GMP GENIUS Nuclease, is >1.2E+06 unit/mg protein. One unit will digest sonicated salmon sperm DNA to 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.
GMP GENIUS Nuclease shows high specific activity.
The specific activity shows that GMP GENIUS Nuclease is stable in different batches.
The specific activity shows that GMP GENIUS Nuclease is stable after 3 freeze-thaws.
ACROBiosystems 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 meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:
- Protein content
- Endotoxin level
- Residual Host Cell DNA content
- Residual Host Cell Protein content
- Biological activity analysis
- Microbial testing
- Mycoplasma testing
- In vitro virus assay
- Batch-to-batch consistency
ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for human in vivo applications.
TERMS AND CONDITIONS
All products are warranted to meet ACROBiosystems Inc.’s (“ACRO”) published specifications when used under normal laboratory conditions.
ACRO DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, ACRO DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
NOT WITH STANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN ACRO AND PURCHASER FOR THE PURCAHSE OF THE PRODUCTS, ACRO’S TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO ACRO FOR THE RELEVANT PRODUCTS. IN NO EVENT WILL ACRO BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.
The End User is aware that ACROBiosystems Inc. and its affiliate (“ACRO”) sell GMP grade products designed for research, manufacturing use or ex vivo use and not intended for human in vivo applications. The End User further agrees, as a condition of the sales of ACRO’s GMP grade products that: a) the End User will not use this GMP grade product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the applicable review board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.