GMP Human Laminin 511 Protein

The schematic diagram of Laminin in ES/iPS cell culture

Download Pre-coating Method Protocol

Product Details

Laminin 511 E8 (LN511-E8) is a recombinant human protein that provides a defined surface for the in vitro feeder-free culture of multiple human pluripotent stem cells (PSCs). As a truncated form of laminin 511, LN511-E8 is a functionally minimal form that retains the full capability for binding to integrins. 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. 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.
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 511 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. GMP Laminin 511 protein (GMP-LA1H25) is the GMP version of laminin 511 protein premium grade (LA8-H5283L), and they have the same performance for a seamless transition.
Optimized and defined surface
Laminin 511 E8 (LN511-E8) has been proven to allow cell seeding at low density. In a feeder-free culture system, the seeded cells demonstrate high motility with higher clonal survival.
Physiology-related
The laminin 511 isoform is crucial to the growth and maintenance of hPSCs in human through its binding to cell receptors a6B1 integrin. LN511-E8 is truncated laminin 511 isoform which works in multiple stem cell lines, from iPSC to hESC and MSC.
Better Adhesion
LN511-E8 variant of laminin 511 shows higher efficiency for supporting the adhesion of dissociated cells than did wild-type laminin 511.
Enhance cell differentiation
Due to the diverse biorelevant environment, GMP Laminin 511 could also enhance cell differentiation, polarization and organization of target cell types.
Reduce Variability
LN511-E8 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. Animal-Free materials
4. Beta-lactam materials free
5. Batch-to-batch consistency
6. Stringent quality control tests

Key parameter

Formulation

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

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 conditions;
2. -20°C or below for 3 years.

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process

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

ACROBIOSYSTEMS - LEGAL NOTICES FOR GMP GRADE PRODUCTS

1. PRODUCT USE RESTRICTIONS & PROHIBITIONS

• 1.1 ACROBiosystems ("ACRO") GMP grade products ("Products") are designed for research, manufacturing use or ex vivo use.
• 1.2 Products are NOT intended for diagnostic purposes or for direct or indirect administration into humans.
• 1.3 Purchaser shall not market, distribute, or resell Products obtained from ACRO without ACRO's prior written consent.

2. REVERSE ENGINEERING PROHIBITED & CONFIDENTIALITY

• 2.1 Purchaser shall not reverse-engineer, decompile, disassemble, sequence, analyze via bioinformatics, or otherwise attempt to discover the structure, sequence, composition, construction, manufacturing process, or any trade secret embodied in the Products. Purchaser shall not permit any third party to undertake such activities.
• 2.2 All specifications, data, and know-how related to the Products provided by ACRO are ACRO's confidential information and shall be protected accordingly.

3. LIMITED WARRANTY & DISCLAIMERS

• 3.1 ACRO warrants solely that Products will conform to their published specifications when used under normal, specified laboratory/manufacturing conditions and within their labeled expiration date. THIS IS THE ONLY WARRANTY PROVIDED.
• 3.2 Purchaser assumes ALL risk and responsibility for:
  (a) Determining the suitability of Products for Purchaser's intended application(s).
  (b) Obtaining any necessary regulatory approvals or intellectual property licenses for Purchaser's use.
  (c) Compliance with all applicable laws, regulations (including but not limited to cGMP/GLP where claimed), and industry standards.
  (d) Conducting all necessary quality control, safety, efficacy, and validation testing of Products within Purchaser's process or final product.
  (e) Proper storage, handling, and use of Products according to ACRO's instructions.
  
• 3.3 ACRO EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO: (A) WARRANTIES OF MERCHANTABILITY; (B) WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE; (C) WARRANTIES OF NON-INFRINGEMENT; AND (D) WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

4. LIMITATION OF LIABILITY

• IN NO EVENT SHALL ACRO, ITS AFFILIATES, OR SUPPLIERS BE LIABLE FOR ANY OF THE FOLLOWING, HOWSOEVER ARISING (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, STATUTE, OR OTHERWISE):
  (a) LOST PROFITS, LOST REVENUE, LOST SAVINGS, LOSS OF USE, LOSS OF DATA, BUSINESS INTERRUPTION, OR ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES.
  (b) ANY DIRECT DAMAGES, COSTS, OR EXPENSES EXCEEDING THE AMOUNT PAID BY PURCHASER FOR THE SPECIFIC PRODUCT(S) GIVING RISE TO THE CLAIM.
  (c) DAMAGES ARISING FROM: (i) MISUSE, ABUSE, OR UNAUTHORIZED MODIFICATION OF PRODUCTS; (ii) USE BEYOND THE EXPIRATION DATE; (iii) IMPROPER STORAGE OR HANDLING; (iv) ACCIDENTAL DAMAGE; (v) FAILURE TO CONDUCT ADEQUATE VALIDATION OR TESTING BY PURCHASER; (vi) INFRINGEMENT CLAIMS RELATED TO PURCHASER'S USE; OR (vii) THE COST OF PROCURING SUBSTITUTE GOODS OR SERVICES.
  (d) ANY PERSONAL INJURY, DEATH, OR DAMAGE TO TANGIBLE PROPERTY TO THE EXTENT PERMITTED BY LAW.

5. END USER ACKNOWLEDGEMENT & COMPLIANCE

• 5.1 By accepting, opening, or using the Products, the End User (Purchaser or its downstream recipient) agrees to be irrevocably bound by all terms herein.
• 5.2 End User explicitly acknowledges the Products are NOT FOR HUMAN ADMINISTRATION and agrees not to use them in any in vivo human application, directly or indirectly.
• 5.3 End Users unwilling to accept these terms must immediately: (a) cease all use; (b) notify ACRO or their supplier; and (c) return the unopened, unused Products. 5.4 ACRO reserves the right to audit End User's compliance with these restrictions upon reasonable notice

ACRO has the right, at its sole discretion, to modify, add or remove any terms herein without notice to Purchaser and/or End User. Any changes to these terms are effective immediately following the updating of such changes on ACRO’s website or published specifications or product-related documents