膜杰作
Star Staining
优势特色（Features）
- Designed under ISO 9001:2015 and ISO 13485:2016
- Manufactured and QC tested under a GMP compliance factory
- FDA DMF filed
- Animal-Free materials
- Batch-to-batch consistency
- Stringent quality control tests
抗体来源（Source）
HEK293 cells-expressed human GMP Monoclonal Anti-Human CD28 Antibody.
亚型（Isotype）
Mouse IgG1 | Mouse Kappa
偶联（Conjugate）
Unconjugated
特异性（Specificity）
This product is a specific antibody specifically reacts with CD28.
内毒素（Endotoxin）
Less than 2 EU/mg by the LAL method.
蛋白A残留（Protein A）
<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.
纯度（Purity）
>95% as determined by SDS-PAGE.
>95% as determined by SEC-HPLC.
无菌（Sterility）
The sterility testing was performed by membrane filtration method described in USP<71> and Ph. Eur. 2.6.1.
支原体（Mycoplasma）
Negative.
制剂（Formulation）
Supplied as 0.2 μm filtered solution in PBS, polysorbate 80, pH7.4 with protectants.
Contact us for customized product form or formulation.
运输（Shipping）
This product is supplied and shipped with dry ice, please inquire the shipping cost.
存储（Storage）
For long term storage, the product should be stored at liquid state at -70°C.
This product is stable after storage at:
- 2-8°C for 12 months under sterile condition;
- -70°C for 5 years.
质量管理控制体系（QMS）
电泳（SDS-PAGE）
GMP Monoclonal Anti-Human CD28 Antibody on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.
SEC-HPLC
The purity of GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) was greater than 95% as determined by SEC-HPLC.
活性（Bioactivity）-CELL BASE
GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) stimulates secretion of IL-2 by PBMC stimulated with 4ng/mL GMP Monoclonal Anti-Human CD3 Antibody (OKT3). The typically EC50 for this effect is 1.382 ng/mL (QC tested).
Protocol
The activity of GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) was higher than other competing products.
稳定性（Stability）
The Cell based assay shows that GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) is stable at 37°C for 7 days.
The Cell based assay shows that GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) is stable after freezing and thawing 3 times.
The Cell based assay shows batch-to-batch consistency between Acro's GMP and PG CD28 Antibody.
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：
- 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） Request For DMF
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
DISCLAIMER
ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for direct human use.
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 PURCHASE 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.
END USER TERMS OF USE OF PRODUCT
The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.
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.
产品推荐（Recommended Products）
背景（Background）
T-cell-specific surface glycoprotein CD28 is also known as TP44, is a single-pass type I membrane protein which contains one Ig-like V-type (immunoglobulin-like) domain. is one of the molecules expressed on T cells that provide co-stimulatory signals, which are required for T cell activation. CD28 is the receptor for CD80 (B7.1) and CD86 (B7.2). When activated by Toll-like receptor ligands, the CD80 expression is upregulated in antigen presenting cells (APCs). The CD86 expression on antigen presenting cells is constitutive. CD28 is the only B7 receptor constitutively expressed on naive T cells.
