GMP Monoclonal Anti-Human CD28 Antibody
Catalog # GMP-MC2824

FeaturesPurity

Designed under ISO 9001:2015 and ISO 13485:2016>95% as determined by SDS-PAGE.

Manufactured and QC tested under a GMP compliance factory>95% as determined by SEC-HPLC.

FDA DMF filed

Sterility

Animal-Free materials

The sterility testing was performed by membrane filtration method described in

Batch-to-batch consistency
Stringent quality control tests

CP<1101>, USP<71> and Ph. Eur. 2.6.1.

Mycoplasma
Negative.

Source
HEK293 cells-expressed human GMP Monoclonal Anti-Human CD28 Antibody.

Isotype

Formulation
Supplied as 0.2 μm filtered solution in PBS, polysorbate 80, pH7.4 withprotectants.

Mouse IgG1/Kappa

Contact us for customized product form or formulation.

Conjugate

Shipping
UnconjugatedThis product is supplied and shipped with dry ice, please inquire the shipping

Specificity

cost.

This product is a specific antibody specifically reacts with CD28.

Storage

Endotoxin
Less than 2 EU/mg by the LAL method.

For long term storage, the product should be stored at liquid state at -70°C.
This product is stable after storage at:Protein A

2-8°C for 12 months under sterile condition;<5 ppm of protein tested by ELISA.

-70°C for 5 years.

Host Cell Protein<0.5 ng/μg of protein tested by ELISA.

Host Cell DNA<0.02 ng/μg of protein tested by qPCR.

SDS-PAGE

SEC-HPLC

GMP Monoclonal Anti-Human CD28 Antibody on SDS-PAGE under reducing

The purity of GMP Monoclonal Anti-Human CD28 Antibody(Cat. No. GMP-(R) condition. The gel was stained with Coomassie Blue. The purity of theMC2824) is more than undefined and the molecular weight of this protein iswww.acrobiosystems.com

9/18/2024GMP Monoclonal Anti-Human CD28 Antibody
Catalog # GMP-MC2824

protein is greater than 95%.

around undefined verified by SEC-MALS.

Bioactivity-Bioactivity CELL BASE

GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824)

The activity of GMP Monoclonal Anti-Human CD28 Antibody (Cat. No.

stimulates secretion of IL-2 by PBMC stimulated with 4ng/mL GMP

GMP-MC2824) was higher than other competing products.

Monoclonal Anti-Human CD3 Antibody (OKT3). The typically EC50 for thiseffect is 1.382 ng/mL (QC tested).

Bioactivity-StabilityThe 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.

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9/18/2024

GMP Monoclonal Anti-Human CD28 Antibody
Catalog # GMP-MC2824

The Cell based assay shows batch-to-batch consistency between Acro's GMP
and PG CD28 Antibody.

MANUFACTURING SPECIFICATIONSACROBiosystems 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 meetstringent 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 testingIn vitro virus assay
Batch-to-batch consistencywww.acrobiosystems.com

9/18/2024

GMP Monoclonal Anti-Human CD28 Antibody
Catalog # GMP-MC2824

BackgroundT-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.

Clinical and Translational Updates

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9/18/2024