GMP Monoclonal Anti-Human CD3 Antibody (OKT3)
Catalog # GMP-MC0323

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 CD3 Antibody(OKT3).

Formulation
Supplied as 0.2 μm filtered solution in PBS, pH7.4 with protectants.

IsotypeContact us for customized product form or formulation.

Mouse IgG2a/kappa

ShippingConjugate
This product is supplied and shipped with dry ice, please inquire the shipping
Unconjugatedcost.

Specificity

Storage

This product is a specific antibody specifically reacts with CD3 epsilon.

Endotoxin

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

Less than 2 EU/mg by the LAL method.

2-8°C for 12 months under sterile condition;-70°C for 5 years.

Protein A<5 ppm of protein tested by ELISA.

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

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9/18/2024

GMP Monoclonal Anti-Human CD3 Antibody (OKT3)
Catalog # GMP-MC0323

GMP Monoclonal Anti-Human CD3 Antibody (OKT3) on SDS-PAGE under

The purity of GMP Monoclonal Anti-Human CD3 Antibody (OKT3)(Cat. No.

reducing (R) condition. The gel was stained with Coomassie Blue. The purity

GMP-MC0323) is more than undefined and the molecular weight of thisof the protein is greater than 95%.

protein is around undefined verified by SEC-MALS.

Bioactivity-Bioactivity CELL BASE

GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (Cat. No. GMP-

The activity of GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (Cat.

MC0323) stimulates secretion of IL-2 by PBMC stimulated with 10 ng/mL

No. GMP-MC0323) was higher than other competing products.

Monoclonal Anti-Human CD28 Antibody, Mouse IgG1. The typically EC50
for this effect is 0.11 ng/mL (QC tested).

Bioactivity-Stability

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.

www.acrobiosystems.com

9/18/2024

GMP Monoclonal Anti-Human CD3 Antibody (OKT3)
Catalog # GMP-MC0323

The Cell based assay shows batch-to-batch consistency between Acro's GMP
and PG CD3 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

www.acrobiosystems.com

9/18/2024

GMP Monoclonal Anti-Human CD3 Antibody (OKT3)
Catalog # GMP-MC0323

Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testing
Mycoplasma testingIn vitro virus assay
Batch-to-batch consistency

BackgroundCD3e 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. Thegenes encoding the epsilon, gamma and delta polypeptides are located in the same cluster on chromosome 11. The epsilon polypeptide plays an essential role in Tcell development. CD3E plays an essential role in T-cell development, and defects in CD3E gene cause severe immunodeficiency. CD3E gene has also been linked toa susceptibility to type I diabetes in women. CD3E has been shown to interact with TOP2B, CD3EAP and NCK2.

Clinical and Translational Updates

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9/18/2024