膜杰作
Star Staining
优势特色（Features）
- Designed under ISO 9001:2015 and ISO 13485:2016
- Manufactured and QC tested under a GMP compliance factory
- 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
产品描述（Product Details）
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.
应用说明（Application）
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
反应条件（Operating Conditions）
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.
纯度（Purity）
>95% as determined by SDS-PAGE.
>99% as determined by SEC-HPLC.
酶活（Enzyme Activity）
≥250 U/μL
宿主蛋白残留（Host Cell Protein）
<0.05 ng/µg of protein tested by ELISA.
蛋白酶活性（Protease Activity）
Negative.
无菌（Sterility）
The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.
支原体（Mycoplasma）
Negative.
内毒素（Endotoxin）
Less than 10 EU/mg by the LAL method.
重金属残留（Heavy Metals）
≤10 ppm
制剂（Formulation）
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.
运输（Shipping）
This product is supplied and shipped with dry ice, please inquire the shipping cost.
存储（Storage）
This product is stable after storage at:
- The product MUST be stored at -20°C or lower upon receipt;
- -20°C for 5 years under sterile conditions.
电泳（SDS-PAGE）
The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.
SEC-HPLC
The purity of GMP GENIUS™Nuclease (Cat. No. GMP-NUES19) was greater than 99% as determined by SEC-HPLC.
活性（Bioactivity）
Specific activity for GMP GENIUS Nuclease is measured under standard assay conditions. The specific activity of GMP GENIUS Nuclease, is > 1.2 x 10^6 unit/mg protein (QC tested). 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,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.
稳定性（Stability）
The specific activity shows that GMP GENIUS™Nuclease (Cat. No. GMP-NUES19) is stable in different batches.
The specific activity shows that GMP GENIUS™Nuclease (Cat. No. GMP-NUES19) is stable after 3 freeze-thaws.
MANUFACTURING SPECIFICATIONS
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） Request For DMF
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:
- SDS-PAGE
- 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
DISCLAIMER
ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for direct human use.
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.
END USER TERMS OF USE OF PRODUCT
The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.
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.
