Features and Advantages
Seamless Transition from Preclinical to Clinical: Same cell clone, process, and QC as GMP products.
Enhanced Production Standards: AOF raw materials, pharma-grade excipients, Grade B+A (ISO 5) environment.
Comprehensive Quality Control: Additional strict testing for process impurities, sterility, and mycoplasma.
Cost-Effective Solution: GMP-comparable quality at an economical price for early development.
Risk Mitigation: Enhanced safety through rigorous impurity control and comprehensive testing.
Source
Monoclonal Anti-Human CD3 Antibody, Mouse IgG2a (Clone: OKT3), premium grade (CDE-M120a) is recombinantly produced from human 293 cells (HEK293).
It is produced under our rigorous quality control system that incorporates a comprehensive set of tests including sterility and endotoxin tests. Product performance is carefully validated and tested for compatibility for cell culture use or any other applications in the early preclinical stage.
GMP-MC0323 is the GMP version of this CDE-M120a. These two proteins display indistinguishable performance profiles, thereby ensuring a seamless transition for end users from early preclinical stage to later clinical phases.
Isotype
Mouse IgG2a | Mouse Kappa
Conjugate
Unconjugated
Specificity
This product is a specific antibody specifically reacts with CD3 epsilon.
Endotoxin
Less than 0.002 EU per μg by the LAL method / rFC method.
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.
Purity
>95% as determined by SDS-PAGE.
>95% as determined by SEC-HPLC.
Sterility
Negative
Mycoplasma
Negative
Formulation
Supplied as 0.2 μm filtered solution in PBS, pH7.4 with trehalose as protectant.
Contact us for customized product form or formulation.
Shipping
This product is supplied and shipped with dry ice, please inquire the shipping cost.
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 conditions;
-70°C for 24 months.
ACRO Quality Management System
QMS(ISO, GMP)
Quality Advantages
Quality Control Process
Quality Description
ACRO's Research-grade products are suitable for a wide range of cell culture applications, particularly for research use in academic institutions. These products are sterilized by filtration before lyophilization. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. Biological activity is calibrated against WHO/NIBSC standards when available.
ACRO's Premium-grade (Pre-GMP) products are characterized by their high quality and enhanced safety profiles, making them ideal for early-stage discovery and manufacturing processes in cell therapy companies. A key advantage is their seamless transition to corresponding GMP-grade versions. Biological activity is calibrated against WHO/NIBSC standards when available. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. In addition, rigorous testing is conducted to ensure the absence of mycoplasma, HCD, and HCP, thereby guaranteeing product safety.
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