GMP Human Laminin 511 Protein (Mix & Scale)

The schematic diagram of Laminin in ES/iPS cell culture

Download Pre-coating Method Protocol

Download Suspension Method Protocol

产品描述（Product Details）

GMP Human Laminin 511 Protein (Mix & Scale) is a recombinant human laminin 511 E8 (LN511-E8) protein that provides a defined surface for in vitro feeder-free culture of multiple human pluripotent stem cells (PSCs).
As published by Takamichi Miyazaki et al., the LN511-E8 variant of laminin 511 shows higher efficiency for supporting the adhesion of dissociated cells than did wild-type laminin 511 which makes it a cost-effective choice.
LN511-E8 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, LN511-E8 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.
Importantly, our innovative laminin 511 protein (Mix & Scale) could meanwhile support pre-coating method and suspension method (directly mixing the protein with cell suspensions without coating plates).
No coating steps are needed and easy scale-up
Simplified operation and support automated manufacturing at a large scale.
Cost-effective
Significant cost reduction compared to classic coating method.
Stemness maintenance
No spontaneous differentiation is observed after several passages of hPSC culture.
Lot-to-lot consistency
Produced from a stable cell line, robust purification process, and stringent QC.
Ready to scale supply
A new cGMP-compliant facility is ready and supports large scale manufacutring supply.

优势特色（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

产品参数（Key parameter）

制剂（Formulation）

Supplied as 0.2 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 dry ice, please inquire the shipping cost.

存储（Storage）

For long term storage, the product should be stored at liquid state at -20℃ or below.

Please avoid repeated freeze-thaw cycles.

This product is stable after storage at:

1. 2-8°C for 6 months under sterile condition;
2. -20°C or below for 3 years.

质量管理控制体系（QMS）

1. 质量管理体系（ISO, GMP）
2. 质量优势
3. 质控流程

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

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

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 PURCHASE 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.