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Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
Animal-Free materials
Beta-lactam materials free
Batch-to-batch consistency
Stringent quality control tests
| Purity (SDS PAGE) | > 95% |
| Mycoplasma Test | Negative |
| Sterility Test | Negative |
| Integrin Binding Assay | 1.00 nM ＜ KD ＜ 30.0 nM |
| Endotoxin Test | < 10 EU/mg |
| Host Cell Protein | < 0.5 ng/µg |
| Host Cell DNA | < 0.02 ng/μg |
Supplied as 0.2 μm filtered solution in PBS, pH7.4 with protectants.
Contact us for customized product form or formulation.
This product is supplied and shipped with dry ice, please inquire the shipping cost.
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:
GMP Human Laminin 511 Protein (Mix & Scale) (Cat. No. GMP-LA1H36) immobilized on CM5 Chip can bind Human ITGA6&ITGB1 Heterodimer Protein, His Tag&Tag Free (Cat. No. IT1-H52W7) with an affinity constant between 1.00 nM - 30.0 nM as determined in a SPR assay (Biacore 8K) (QC tested).
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）
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
Batch-to-batch consistency
Price(USD) : $330.00
Price(USD) : $1300.00
Price(USD) : $7875.00
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