Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
Stringent quality control tests
No animal derived peptone and lactose used in production process
clinical viral vaccine production
clinical viral vector production for cell and gene therapy（CGT）
Other clinical development and production uses
≥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.
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
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
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:
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
In vitro virus assay
Please contact us via TechSupport@acrobiosystems.com if you have any question on this product.
Price(EUR) : €560.00
Price(EUR) : €1880.00
Price(EUR) : Inquire
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