- Designed under ISO 9001:2015 and ISO 13485:2016
- Manufactured and QC tested under a GMP compliance factory
- Animal-Free materials
- Batch-to-batch consistency
- Stringent quality control tests
HEK293 cells-expressed human GMP Monoclonal Anti-Human CD3 Antibody (OKT3).
The cross-reactivity with other species has not been tested yet.
>95% as determined by SDS-PAGE.
>95% as determined by SEC-HPLC.
Less than 2 EU/mg by the LAL method.
<5 ppm of protein tested by ELISA.
宿主蛋白残留（Host Cell Protein）
<0.5 ng/μg of protein tested by ELISA.
宿主核酸残留（Host Cell DNA）
<0.02 ng/μg of protein tested by qPCR.
The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.
Supplied as 0.2 μm filtered solution in PBS, pH7.4 with trehalose as protectant.
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:
- 2-8°C for 12 months under sterile condition;
- -70°C for 5 years.
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) was greater than 95% as determined by SEC-HPLC.
活性（Bioactivity）-Bioactivity CELL BASE
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.
- 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:
- 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
ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for human in vivo applications.
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 PURCAHSE 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.
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.
CD3e molecule, epsilon is also known as CD3E, is a T-cell surface single-pass type I membrane glycoprotein. CD3E contains 1 Ig-like (immunoglobulin-like) domain and 1 ITAM domain. CD3E, together with CD3-gamma, CD3-delta and CD3-zeta, and the T-cell receptor alpha/beta and gamma/delta heterodimers, forms the T cell receptor-CD3 complex. This complex plays an important role in coupling antigen recognition to several intracellular signal-transduction pathways. The genes encoding the epsilon, gamma and delta polypeptides are located in the same cluster on chromosome 11. The epsilon polypeptide plays an essential role in T-cell development. CD3E plays an essential role in T-cell development, and defects in CD3E gene cause severe immunodeficiency. CD3E gene has also been linked to a susceptibility to type I diabetes in women. CD3E has been shown to interact with TOP2B, CD3EAP and NCK2.