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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
Unconjugated
>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.
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.
The Cell based assay shows batch-to-batch consistency between Acro's GMP and PG CD3 Antibody.
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:
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
Emerging VoCs, Omicron, Delta, Beta, Alpha mutants and so on, including RBD, S trimer, S1, NTD, NP, etc. These mutants are of high purity and bioactivity and can be used to evaluate the efficacy of the antibodies and vaccination.
ACROBiosystems developed a series of GMP grade cytokines under the GMP grade quality management system. Those products are all suitable for T/NK cell generation, activation, and proliferation in cell therapy research.
50+ targets designed for CAR detection, including PE/FITC/biotin labeled proteins. The key reagents for CD19 and BCMA were FDA DMF filed which can support your IND, NDA and BLA process.
GMP grade cytokines, reagents for cell activation, gene edition, DNA/RNA removal, etc. Particularly focus on product design, quality control and solution-based support to link each phase of your cell and gene therapy journey.
Full length multi-pass TPs with stabilized structure and high bioactivity for immunization, antibody screening, cell based assay and CAR detection, including hot CD20, Claudin 18.2， CD133, GPRC5D，CCR8, CCR5, etc.
CD3 proteins and a collection of for bispecific antibody development which are of high specificity and bioactivities and suitable for immunization, antibody screening.
A series of immune checkpoints including classic co-inhibitory and co-stimulatory receptors. The comprehensive catalog contains 100+ targets with various species and tags, and the high-quality proteins are in good batch-to-batch consistency.
To meet the needs of ADCs development, ACROBiosystems can provide: A variety of high-quality target proteins; MMPs/Cathepsin/uPA for cleavable linker; Anti-payload antibodies & anti-idiotypic antibodies for immunogenicity and PK analysis; SPR/BLI analytical and ADA development service.
Comprehensive collection of Fc receptor proteins, including their common variants, which can help expedite your antibody development.
The MABSOL biotinylated protein collection includes more than a hundred commonly studied drug targets and biomarker proteins.
Comprehensive cytokines including IL families, growth factors, chemokines, TNFs, etc. These products are HEK293 expressed and nearly in authentic structure, high purity and bioactivity, cell based assay/SPR/BLI verified.
To support preclinical/clinical immunogenicity and PK analysis, ACROBiosystems has developed a series of high-affinity anti-idiotypic antibodies. Our pipeline covers five hot targets including adalimum*b, rituxim*b, cetuxim*b, trastuzum*b, and bevacizum*b.
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