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Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
Stringent quality control tests
This protein carries no "tag"
The protein has a calculated MW of 15.5 kDa. The protein migrates as 13-19 kDa under reducing (R) condition (SDS-PAGE) due to glycosylation.
>95% as determined by SDS-PAGE.
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with trehalose as protectant.
Contact us for customized product form or formulation.
Please see Certificate of Analysis for specific instructions.
For best performance, we strongly recommend you to follow the reconstitution protocol provided in the CoA.
Shipping at ambient temperature. 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 24 months in lyophilized state from date of receipt;
-70°C for 12 months under sterile conditions after reconstitution.
GMP Human IL-21 Protein on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.
GMP Human IL-21 Protein (Cat. No. GMP-L21H25) stimulates secretion of IFN-γ by NK-92 human natural killer lymphoma cells stimulated with 10 ng/mL GMP Human IL-15 Protein (Cat. No. GMP-L15H13). The specific activity of GMP Human IL-21 Protein (Cat. No. GMP-L21H25) is > 1ⅹ10^5 U/mg (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.
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
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:
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
In vitro virus assay
Please contact us via TechSupport@acrobiosystems.com if you have any question on this product.
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