GMP Monoclonal Anti-Human CD16 Antibody (3G8)

• Wide-ranging functions: Acts as a key functional reagent to support the specific activation and expansion of natural killer (NK) cells in adoptive cell therapy workflows, while enhancing antibody-dependent cellular cytotoxicity (ADCC) and effector function in CAR-NK, TIL, and NK cell cultures.
• High Performance: Exhibits superior binding specificity to CD16 and potent biological activity, making it the preferred choice for numerous pharmaceutical enterprises in preclinical and clinical-stage NK cell therapy development and cancer immunotherapy research.
• Comprehensive Safety Assurance: ATCC-compliant CHO host cell origin and comprehensive testing (52 items), animal origin-free (AOF) production process, with stringent final product quality control and release specifications to support clinical-grade applications.
• Lot-to-Lot Consistency: Achieved through a stable cell line and robust manufacturing process, ensuring reliable, reproducible functional performance from early-stage research through clinical manufacturing.

• Quality Assurance: Global QMS with comprehensive and stringent QC release criteria.
• End-to-End GMP Compliance: Full manufacturing and QC under a cGMP system.
• Comprehensive Control of Adventitious Agents: Stringent biosafety from cell banks to final release.
• Comprehensive Regulatory Support: Includes RSF and DMF to meet global requirements.
• Resilient Supply Chain: Intelligent modular facilities ensure a stable global supply.
• Professional Support: Extensive manufacturing and application expertise to accelerate development.

GMP Monoclonal Anti-Human CD16 Antibody (3G8) (GMP-MC1639) is recombinantly produced from CHO cells.

Mouse IgG1, Kappa

This product is a specific antibody that specifically reacts with CD16/Fc gamma RIII.

Less than 2 EU/mg, tested by the rFC method in compliance with USP <86> and Ph. Eur. 2.6.32.

<5 ppm of protein tested by ELISA.

<0.5 ng/μg of protein tested by ELISA.

<0.02 ng/μg of protein tested by qPCR.

>95% as determined by SDS-PAGE.

Sterility testing was performed using the membrane filtration method in compliance with USP <71> and Ph. Eur. 2.6.1.

Negative

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

Contact us for customized product form or formulation.

2R (13 mm neck finish)

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.

Please avoid repeated freeze-thaw cycles.

• -70°C for 5 years;
• -20°C for 12 months under sterile conditions;
• 2-8°C for 6 months under sterile conditions.