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Description
The recombinant humanized anti-CD16 monoclonal antibody is a high-affinity therapeutic agent specifically targeting the membrane-proximal epitope of FcγRIII (CD16). It is produced either via CHO stable cell expression for GMP-compliant manufacturing or via HEK-293 transient transfection technology for RUO applications. By precisely mimicking the spatial conformation of natural IgG-Fc binding patterns, this antibody activates Syk/ZAP70 kinase-dependent phosphorylation cascades, triggering calcium influx and intracellular calcium flux as well as PI3K-AKT/mTOR-MAPK signaling pathways in NK cells, thereby enhancing antibody-dependent cellular cytotoxicity (ADCC) and stimulating secretion of proinflammatory cytokines such as IFN-γ and TNF-α.
In ex vivo NK cell expansion systems, the antibody significantly improves CD107a degranulation efficiency and proliferation rates while synergizing with IL-2/IL-15 to maintain metabolic adaptability and sustain the metabolic fitness of effector memory NK cell subsets (CD56dim/CD16+).
Manufactured under animal component-free conditions using animal component-free culture media and multi-step chromatographic purification, the product complies with release specifications through stringent control of host DNA residuals, host protein contaminants, and endotoxin levels. The CHO-derived GMP-grade material supports translational and clinical cell therapy workflows, while the HEK-293–derived RUO-grade material is optimized for research and platform development.
It is designed for applications in CAR-NK engineering, bispecific antibody-engaged immune cell therapy platforms, tumor vaccine adjuvant systems, and broader NK cell–based immunotherapy development.
Specifications
| Test Item | Specification | RUO Results | GMP Results |
|---|---|---|---|
| Appearance | Should be a colorless and transparent liquid | Compliance | Compliance |
| Identity | The electrophoretic bands should be consistent with the molecular weight of the product | Compliance | Compliance |
| Visible Particle | Should be no visible particle | Compliance | Compliance |
| pH | 6.5 – 7.5 | 7.39 | 7.4 |
| Concentration | 1.0 – 1.5 mg/mL | 1.0 mg/mL | 1.1 mg/mL |
| Purity | >90.0% | Compliance | Compliance |
| Endotoxin | <0.1 EU/μg | <0.1 EU/μg | <0.1 EU/μg |
| Mycoplasma | Should be negative | Negative | Negative |
| Sterility | No growth | No growth | No growth |
| Functional / Activity Assay | Binding to PBMC cells was 80%–150% of the positive control | — | 122% |
| Host Cell Protein Residues (CHO-HCP) | <500 ng/mg | Compliance | — |
| Host Cell (CHO) DNA Remains | <20 ng/mg | Compliance | — |
Features
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Dual-Grade Availability (RUO & GMP)
Available in both Research Use Only (RUO) and GMP-compliant formats to support early-stage research, translational studies, and regulated manufacturing workflows.
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High Purity and Consistent Quality
Purity verified to be >90%, with strict control of physicochemical properties including appearance, pH (6.5–7.5), and concentration (1.0–1.5 mg/mL) to ensure batch-to-batch consistency.
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Ultra-Low Endotoxin Level
Endotoxin content controlled at <0.1 EU/μg, suitable for sensitive cell-based assays and downstream functional studies.
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Stringent Safety Testing
Tested negative for mycoplasma, confirmed sterile (no growth), and free of visible particles, ensuring reliability in cell culture and bioassay applications.
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Low Residual Host Cell Impurities (GMP Grade)
GMP-grade material is tested for host cell protein (CHO-HCP) residues (<500 ng/mg) and residual host cell DNA (<20 ng/mg), meeting regulatory expectations for biologics manufacturing.
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Validated Biological Activity (GMP Grade)
Demonstrated functional activity with PBMC binding activity within 80–150% of the positive control, with a measured activity of 122%, confirming biological relevance.
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Liquid Formulation for Direct Use
Supplied as a colorless, transparent liquid at defined concentration, minimizing preparation time and reducing handling variability.
Applications
RUO Grade
Cell-based assays
Cell-based assays for receptor binding, signaling, and functional screening
Immunology & cell biology research
Immunology and cell biology research
Assay development
Assay development and method optimization
Early-stage discovery
Early-stage discovery and proof-of-concept studies
GMP Grade
Cell therapy development
Cell therapy and immunotherapy development
Process development & scale-up
Process development and scale-up under GMP conditions
Functional potency testing
Functional potency testing using PBMC-based assays
Manufacturing support
Manufacturing support for clinical and preclinical biologics
Storage
Store at 2–8 °C. Do not freeze. Protect from light.
Documents
📄 GMP-TL201 Data Sheet 📄 GMP-TL201 SDS 📄 GMP-TL201 COA 📄 TL-201 Data Sheet 📄 TL-201 SDS 📄 TL-201 COA
Attention
For research and manufacturing purposes only.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
