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GMP GENPower™ NLS-Cas9 Nuclease

フォーカス製品一覧:
PG version CA9-S5149 is now available for seamless transition.
  • Features
    1. Designed under ISO 9001:2015 and ISO 13485:2016

    2. Manufactured and QC tested under a GMP compliance factory

    3. Animal-Free materials

    4. Beta-lactam materials free

    5. Batch-to-batch consistency

    6. Stringent quality control tests

    7. No animal derived peptone and lactose used in production process
  • Product Details
    GMP GENPower™ NLS-Cas9 Nuclease is a recombinant Streptococcus pyogenes Cas9 protein purified from Escherichia coli for CRISPR-based genome editing. The introduction of nuclear localization signals (NLS) can help Cas9 enter the nucleus, increasing the chance of genomic DNA cleavage.
  • Application

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

  • Concentration
    10 mg/mL
  • Purity

    >95% as determined by SDS-PAGE.

    >95% as determined by SEC-HPLC.

  • Host Cell Protein
    ≤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

    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.

  • Shipping

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

  • Storage

    This product is stable after storage at:

    1. The product MUST be stored at -20°C or lower upon receipt;
    2. -20°C for 5 years under sterile conditions.
SDS-PAGE
CAS9 SDS-PAGE

The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).

SEC-HPLC
CAS9 SEC-HPLC

The purity of GMP GENPower™ NLS-Cas9 Nuclease (Cat. No. GMP-CA9S18) was greater than 95% as determined by SEC-HPLC.

Bioactivity
 CAS9 ENZYME

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%. In comparison, when using a 200 ng Competitor T, the cutting efficiency is only about 50%.

 CAS9 ENZYME

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.

  • 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:

    1. Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.

    2. Animal-Free materials

    3. Materials purchased from the approved suppliers by QA

    4. ISO 5 clean rooms and automatic filling equipment

    5. Qualified personnel

    6. Quality-related documents review and approve by QA

    7. Fully batch production and control records

    8. Equipment maintenance and calibration

    9. Validation of analytical procedures

    10. Stability studies conducted

    11. 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:

    1. SDS-PAGE

    2. Protein content

    3. Endotoxin level

    4. Residual Host Cell DNA content

    5. Residual Host Cell Protein content

    6. Biological activity analysis

    7. Microbial testing

    8. Mycoplasma testing

    9. In vitro virus assay

    10. Batch-to-batch consistency

  • Clinical and Translational Updates

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ETD of in-stock products: 4 business days

価格(JPY) : 2,021,600

価格(JPY) : 3,875,200

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