GMP Human Laminin 521 Protein (GMP Laminin 521) is a recombinant human protein that offers a defined surface for the feeder-free culture of various human pluripotent stem cells (PSCs) in vitro. GMP Laminin 521 has been shown to preserve normal growth characteristics and stemness in multiple PSC lines, including ESC, iPSC, MSC, etc., without inducing differentiation.
GMP Laminin 521 has also been proven to support PSC growth for over 10 passages without any evidence of karyotypic abnormalities and to retain the ability of PSCs to differentiate into all three germ lineages.
High-quality products and regulatory support files ensure a smooth transition from preclinical research and development to cell therapy clinical studies. GMP Laminin 521 is designed for clinical research and produced through an animal-free process in a GMP-compliant facility.
A comprehensive range of QC tests is conducted to guarantee product quality, including assessments for purity, bioactivity, sterility, mycoplasma, endotoxin, and more. GMP Laminin 521 protein (GMP-LA5H24) is the GMP version of the premium-grade laminin 521 protein (LA5-H5261), offering identical performance for a seamless transition.
Flexible and compatible
GMP Laminin 521 is compatible with any commercial stem cell media and can support the attachment and expansion of hPSCs as single cells or small colonies.
Stemness maintenance
GMP Laminin 521 is the biologically relevant extracellular matrix for hPSCs. It plays a crucial role in the growth and maintenance of stemness in hPSCs by binding to the a6β1 integrin cell receptors.
Enhance cell differentiation
Due to its biorelevant properties, GMP Laminin 521 also promotes cell differentiation, polarization, and organization of target cell types, such as neurons, hepatocytes, cardiomyocytes, retinal pigmented epithelial cells, and pancreatic β-cells.
Reduce variability
GMP Laminin 521 is a defined, recombinant human protein that offers improved lot-to-lot consistency, helping to reduce variability in the PSC cultures.
Features
- Developed in compliance with ISO 9001:2015 and ISO 13485:2016 standards
- Produced and quality control tested in a GMP-compliant facility
- Ensures batch-to-batch consistency
- Free from beta-lactam materials
- FDA DMF filed
- Made with animal-free materials
- Subjected to rigorous quality control tests
Key parameter
Source: ACROBiosystems Inc
| test |
test |
| Purity (SDS PAGE) |
> 95% |
| Mycoplasma Test |
Negative |
| Sterility Test |
Negative |
| Integrin Binding Assay |
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 |
| In vitro virus assay |
Negative |
Formulation
Lyophilized from a 0.22 μm filtered solution in PBS, pH 7.4, with protectants.
Shipping
Supplied and shipped with blue ice.
Storage
Upon receipt, store immediately at -20 °C or lower for long-term storage.
Avoid repeated freeze-thaw cycles.
The product remains stable when stored at:
- -20 °C to -70 °C for 5 years in its lyophilized state
- -70 °C for 12 months under sterile conditions after reconstitution
ACRO quality management system
- Quality Advantages
- QMS（ISO, GMP）
- Quality Control Process
QC and assay protocol
Bioactivity-Stem cell culture
Image Credit: ACROBiosystems Inc
GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) can maintain the stemness of iPSCs over multiple passages.
Image Credit: ACROBiosystems Inc
GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) supports the rapid expansion of single-cell hPSCs.
Image Credit: ACROBiosystems Inc
GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) preserves the stemness of iPSCs through several passages.
Bioactivity-BLI
Image Credit: ACROBiosystems Inc
The loaded Human ITGA6&ITGB1 Heterodimer Protein, His Tag&Tag Free (Cat. No. IT1-H52W7), when bound to the HIS1K Biosensor, shows an affinity constant between 0.50 nM and 5.00 nM for GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24), as determined by a BLI assay (ForteBio Octet Red96e) (QC tested).
Bioactivity-Stability
Image Credit: ACROBiosystems Inc
The BLI-based assay also demonstrates that GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) remains stable at 4 °C for up to 30 days.
Image Credit: ACROBiosystems Inc
The BLI-based assay demonstrates that the GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) remains stable at 37 °C for 24 hours.
Image Credit: ACROBiosystems Inc
The BLI-based assay shows that GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) is stable after being frozen and thawed three times.
Image Credit: ACROBiosystems Inc
The BLI-based assay indicates batch-to-batch consistency between ACRO's GMP and PG Laminin 521.