Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
Stringent quality control tests
>95% as determined by SDS-PAGE.
>95% as determined by SEC-HPLC.
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 -70°C.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
GMP Monoclonal Anti-Human CD3 Antibody (OKT3) on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.
The purity of GMP Monoclonal Anti-Human CD3 Antibody (OKT3)(Cat. No. GMP-MC0323) is more than undefined and the molecular weight of this protein is around undefined verified by SEC-MALS.
GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (Cat. No. GMP-MC0323) stimulates secretion of IL-2 by PBMC stimulated with 10 ng/mL Monoclonal Anti-Human CD28 Antibody, Mouse IgG1. The typically EC50 for this effect is 0.11 ng/mL (QC tested).
The activity of GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (Cat. No. GMP-MC0323) was higher than other competing products.
The Cell based assay shows that GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (Cat. No. GMP-MC0323) is stable at 37°C for 7 days.
The Cell based assay shows that GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (Cat. No. GMP-MC0323) is stable after freezing and thawing 3 times.
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
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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