膜杰作
Star Staining
产品描述（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.
优势特色（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
产品参数（Key parameter）
| 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 |
制剂（Formulation）
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.
Contact us for customized product form or formulation.
运输（Shipping）
This product is supplied and shipped with blue ice, please inquire the shipping cost.
存储（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:
- -20°C to -70°C for 5 years in lyophilized state;
- -70°C for 12 months under sterile conditions after reconstitution.
活性（Bioactivity）-Stem Cell CultureView 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.
活性（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 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).
Protocol
稳定性（Stability）
The BLI based assay shows that GMP Human Laminin 521 Protein (Cat. No. GMP-LA5H24) is stable at 4℃ for 30 days.
The BLI based assay shows that GMP Human Laminin 521 Protein (Cat. No. 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 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：
- 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
- 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） Request For DMF
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:
- SDS-PAGE
- Protein content
- Endotoxin level
- Residual Host Cell DNA content
- Residual Host Cell Protein content
- Biological activity analysis
- Microbial testing
- Mycoplasma testing
- In vitro virus assay
- Residual moisture
- Batch-to-batch consistency
DISCLAIMER
ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for direct human use.
TERMS AND CONDITIONS
All products are warranted to meet ACROBiosystems Inc.’s (“ACRO”) published specifications when used under normal laboratory conditions.
ACRO DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, ACRO DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
NOT WITH STANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN ACRO AND PURCHASER FOR THE PURCAHSE OF THE PRODUCTS, ACRO’S TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO ACRO FOR THE RELEVANT PRODUCTS. IN NO EVENT WILL ACRO BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.
END USER TERMS OF USE OF PRODUCT
The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.
The End User is aware that ACROBiosystems Inc. and its affiliate (“ACRO”) sell GMP grade products designed for research, manufacturing use or ex vivo use and not intended for human in vivo applications. The End User further agrees, as a condition of the sales of ACRO’s GMP grade products that: a) the End User will not use this GMP grade product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the applicable review board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.
