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

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.
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.
Ultra-Low Endotoxin Level

Endotoxin content controlled at <0.1 EU/μg, suitable for sensitive cell-based assays and downstream functional studies.
Stringent Safety Testing

Tested negative for mycoplasma, confirmed sterile (no growth), and free of visible particles, ensuring reliability in cell culture and bioassay applications.
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.
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.
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.

Anti-Human CD16 Monoclonal Antibody (CD16 Mab)