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Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
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
• Genetic modification of cells and gene therapy drugs (T cell, hematopoietic stem cell)
• High specificity detection of pathogens
>95% as determined by SDS-PAGE.
>95% as determined by SEC-HPLC.
Supplied as 0.2 μm filtered solution in 20 mM Tris, 300 mM NaCl, 0.1 mM EDTA, 1 mM TCEP, pH7.5.
Contact us for customized product form or formulation.
This product is supplied and shipped with dry ice, please inquire the shipping cost.
This product is stable after storage at:
The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).
The purity of GMP GENPower™ NLS-Cas9 Nuclease (Cat. No. GMP-CA9S18) was greater than 95% as determined by SEC-HPLC.
Different amounts of Cas9 were incubated with the same amount of excess gRNA and plasmid for 60 minutes at 37°C. When using 400-200 ng Acro Cas9, the cutting efficiency is greater than 90% (QC tested). In comparison, when using a 200 ng Competitor T, the cutting efficiency is only about 50%.
The TCR knockout efficiency with GMP GENPower™ NLS-Cas9 Nuclease in human primary T cells, GMP GENPower™ NLS-Cas9 Nuclease achieved over 95% knockout efficiency.
The cleavage efficiency in HEK293 cell 72 hours after electroporation of GMP GENPower™ NLS-Cas9 Nuclease RNP.
The cleavage efficiency in iPSC 72 hours after electroporation of GMP GENPower™ NLS-Cas9 Nuclease RNP.
The knockout efficiency for B2M in primary T cell was measured by Flow Cytometry.
The knockout efficiency for TRAC in Jurkat cell was measured by Flow Cytometry.
The knockout efficiency for B2M in Jurkat cell was measured by Flow Cytometry.
The bioactivity based assay shows batch-to-batch consistency between Acro's GMP and PG Cas9.
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:
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
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