GMP Human Laminin 521 Protein
Catalog # GMP-LA5H24

Product Details

Key parameter

GMP Human Laminin 521 Protein (GMP Laminin 521) is a recombinant humanprotein that provides a defined surface for in vitro feeder-free culture of multiple

Purity (SDS PAGE)> 95%

Mycoplasma Test

Negative

Sterility Test

Negative

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 theIntegrin Binding Assayability of PSCs to differentiate into all three germ line lineages.

0.5 nM ＜ KD ＜ 5 nM

Endotoxin Test

< 10 EU/mg

Host Cell Protein< 0.5 ng/µg

Host Cell DNA< 0.02 ng/μg

High-quality products and regulatory support files are essential for the smoothtransition from preclinical research & development to cell therapy clinical study.
Designed for clinical research, GMP Laminin 521 is manufactured by an animalfree process in a GMP-compliant facility. A full battery of QC testing is
implemented to ensure product quality, including purity, bioactivity, sterility,

In vitro virus assay

Negative

mycoplasma, endotoxin, etc.

Formulation
Flexible & Compatible
GMP Laminin 521 could work well in any commercial stem cell media.

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

Meanwhile, it could support the attachment and expansion of hPSCs both inContact us for customized product form or formulation.

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

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

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

Due to the diverse biorelevant environment, GMP Laminin 521 could also

Please avoid repeated freeze-thaw cycles.

enhance cell differentiation, polarization and organization of target cell types,

This product is stable after storage at:including neurons, hepatocytes, cardiomyocytes, retinal pigmented epithelial
cells, pancreatic β-cells, and so on.

-20°C to -70°C for 5 years in lyophilized state;-70°C for 12 months under sterile conditions after reconstitution.

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
Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
FDA DMF filed
Animal-Free materials
Beta-lactam materials free
Batch-to-batch consistency
Stringent quality control tests

www.acrobiosystems.com

9/18/2024

GMP Human Laminin 521 Protein
Catalog # GMP-LA5H24

Bioactivity-Stem Cell Culture
View Protocol

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

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

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

Bioactivity-BLI

Loaded Human ITGA6&ITGB1 Heterodimer Protein, His Tag&Tag Free (Cat.
No. IT1-H52W7) on HIS1K Biosensor, can bind GMP Human Laminin 521

www.acrobiosystems.com

9/18/2024

GMP Human Laminin 521 Protein
Catalog # GMP-LA5H24

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

The BLI based assay shows that GMP Human Laminin 521 Protein (Cat. No.

The BLI based assay shows that GMP Human Laminin 521 Protein (Cat. No.

GMP-LA5H24) is stable at 4℃ for 30 days.

GMP-LA5H24) is stable at 37℃ for 24 hours.

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

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

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

www.acrobiosystems.com

9/18/2024

GMP Human Laminin 521 Protein
Catalog # GMP-LA5H24

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 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
Residual moisture
Batch-to-batch consistency

Clinical and Translational Updates

www.acrobiosystems.com

9/18/2024