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GMP Human Laminin 521 Protein DMF

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  • Product Details
    GMP Human Laminin 521 Protein (GMP Laminin 521) is a recombinant human protein that provides a defined surface for in vitro feeder-free culture of multiple human pluripotent stem cells (PSCs). GMP Laminin 521 has been proven to maintain normal growth characteristics and stemness in multiple PSC lines without simultaneous differentiation, which includes ESC, iPSC, MSC, etc. In addition, GMP Laminin 521 has been demonstrated to support PSC growth for >10 passages without any signs of karyotypic abnormalities and to maintain the ability of PSCs to differentiate into all three germ line lineages.
    High-quality products and regulatory support files are essential for the smooth transition from preclinical research & development to cell therapy clinical study. Designed for clinical research, GMP Laminin 521 is manufactured by an animal-free process in a GMP-compliant facility. A full battery of QC testing is implemented to ensure product quality, including purity, bioactivity, sterility, mycoplasma, endotoxin, etc.

    Flexible & Compatible
    GMP Laminin 521 could work well in any commercial stem cell media. Meanwhile, it could support the attachment and expansion of hPSCs both in single cells or small colonies.

    Stemness maintenance
    GMP Laminin 521 is the biologically relevant hPSCs extracellular matrix. It is crucial for the growth and stemness maintenance of hPSCs in human through its binding to cell receptors a6β1 integrin.

    Enhance cell differentiation
    Due to the diverse biorelevant environment, GMP Laminin 521 could also enhance cell differentiation, polarization and organization of target cell types, including neurons, hepatocytes, cardiomyocytes, retinal pigmented epithelial cells, pancreatic β-cells, and so on.

    Reduce Variability
    GMP Laminin 521 is a defined, recombinant human protein with better lot-to-lot consistency that reduces variability in your PSC cultures.
  • Features
    1. Designed under ISO 9001:2015 and ISO 13485:2016

    2. Manufactured and QC tested under a GMP compliance factory

    3. FDA DMF filed

    4. Animal-Free materials

    5. Beta-lactam materials free

    6. Batch-to-batch consistency

    7. Stringent quality control tests

  • Key parameter
    Purity (SDS PAGE)> 95%
    Mycoplasma TestNegative
    Sterility TestNegative
    Integrin Binding Assay0.5 nM < KD < 5 nM
    Endotoxin Test< 10 EU/mg
    Host Cell Protein< 0.5 ng/µg
    Host Cell DNA< 0.02 ng/μg
    In vitro virus assayNegative
  • Formulation

    Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.

    Contact us for customized product form or formulation.

  • Shipping

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

  • Storage

    Upon receipt, store it immediately at -20°C or lower for long term storage.

    Please avoid repeated freeze-thaw cycles.

    This product is stable after storage at:

    1. -20°C to -70°C for 5 years in lyophilized state;
    2. -70°C for 12 months under sterile conditions after reconstitution.
Bioactivity-Stem Cell Culture
 Laminin 521 STEM CELL CULTURE

GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) could maintain the stemness of iPSC after several passages.

 Laminin 521 STEM CELL CULTURE

GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) could support the rapid expansion of single cell hPSCs.

 Laminin 521 STEM CELL CULTURE

GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) could maintain the stemness of iPSC after several passages.

Bioactivity-BLI
 Laminin 521 BLI

Loaded Human ITGA6&ITGB1 Heterodimer Protein, His Tag&Tag Free (Cat. No. IT1-H52W7) on HIS1K Biosensor, can bind GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) with an affinity constant between 0.50 nM - 5.00 nM as determined in BLI assay (ForteBio Octet Red96e) (QC tested).

Bioactivity-Stability
 Laminin 521 STABILITY

The BLI based assay shows that GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) is stable at 4℃ for 30 days.

 Laminin 521 STABILITY

The BLI based assay shows that GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) is stable at 37℃ for 24 hours.

 Laminin 521 STABILITY

The BLI based assay shows that GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) is stable after freezing and thawing 3 times.

 Laminin 521 STABILITY

The BLI based assay shows batch-to-batch consistency between Acro's GMP and PG Laminin 521.

  • 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. Residual moisture
    11. Batch-to-batch consistency

  • Clinical and Translational Updates

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ETA des produits en stock: 2 jours ouvrables

Price(EUR) : €190.00

Price(EUR) : €800.00

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