GMP GENPower™ NLS-Cas9 Nuclease
Catalog # GMP-CA9S18Features

Host Cell Protein

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

Product Details≤10 ng/mg of protein tested by ELISA.

Host Cell DNA≤1 ng/mg of protein tested by qPCR.

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

Endotoxin
Less than 10 EU/mg by the LAL method.

Formulation

GMP GENPower™ NLS-Cas9 Nuclease is a recombinant Streptococcus
pyogenes Cas9 protein purified from Escherichia coli for CRISPR-based genome

Supplied as 0.2 μm filtered solution in 20 mM Tris, 300 mM NaCl, 0.1 mM

editing. The introduction of nuclear localization signals (NLS) can help Cas9

EDTA, 1 mM TCEP, pH7.5.

enter the nucleus, increasing the chance of genomic DNA cleavage.

Application

Contact us for customized product form or formulation.

Shipping• Genetic modification of cells and gene therapy drugs (T cell, hematopoieticstem cell)• High specificity detection of pathogens

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

Storage

Concentration

This product is stable after storage at:

10 mg/mL

The product MUST be stored at -20°C or lower upon receipt;

Purity-20°C for 5 years under sterile conditions.

>95% as determined by SDS-PAGE.
>95% 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 GENPower™ NLS-Cas9 Nuclease (Cat. No. GMP-than 95% (With Star Ribbon Pre-stained Protein Marker).

CA9S18) was greater than 95% as determined by SEC-HPLC.

Bioactivity

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9/18/2024

GMP GENPower™ NLS-Cas9 Nuclease
Catalog # GMP-CA9S18

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 AcroCas9, 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.

Bioactivity-Stability

The bioactivity based assay shows batch-to-batch consistency between Acro's
GMP and PG Cas9.

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

www.acrobiosystems.com

9/18/2024GMP GENPower™ NLS-Cas9 Nuclease
Catalog # GMP-CA9S18

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
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

www.acrobiosystems.com

9/18/2024