Antibody Development

Expertise in Antibody Engineering & Functional Immunology

With over 15 years of dedicated experience in antibody therapeutics, we support the full spectrum of antibody-based drug discovery—from early target validation to preclinical development. Our team combines deep immunology expertise with practical experience in monoclonal antibodies (mAbs), bispecifics, ADCs, and immune cell engagers to deliver actionable, translationally relevant data.

  • ADCC
  • ADC
  • Immunogenicity
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Our Comprehensive Antibody Services

Functional Assessment

  • Fc Effector Function: ADCC (NK cell-mediated killing), ADCP (macrophage phagocytosis), CDC (complement activation).

  • Neutralization assays (receptor-ligand blockade)


Developability and Safety: Immunogenicity risk assessment (T-cell epitope mapping, ADA)

Target Binding Profiling

  • Affinity measurements (flow cytometry)

  • Cross-reactivity screening

Mechanistic Validation

  • T-cell redirecting bispecifics (BiTEs, DARTs)

    • Target dependent T-cell activation (CD69/CD25 expression, INF-ϒ release)
    • Tumor cell killing (co-culture with PBMCs or engineering Jurkat reporter cells)
  • Tumor Microenvironment (TME) Modulation 
    • Checkpoint inhibitor bispecifics (PD-1/CTLA-4, LAG-3/TIM-3)
    • Cytokine antibody fusions (IL-2/IL-15 payloads)

 

 

Analytical Characterization: Drug-to-antibody ratio (DAR) by HIC-HPLC

Functional Potency:

  • Cell-killing mechanisms: Proliferation inhibition (MTT/XTT), apoptosis (caspase-3/7 activation).

  • Fc-mediated activity: ADCC/ADCP using engineered effector cells (Promega reporter assays).

Stability & PK/PD:

  • Serum stability (DAR decay over time).

  • Anti-drug antibody (ADA) assays for immunogenicity.

Target Engagement & Internalization: Flow cytometry (cell surface retention, antigen shedding).

Functional Potency:

  • Cytotoxicity

  • Cytokine storm profiling (IL-6, IFN-γ, TNF-α via MSD/ELISA).

Exhaustion and Persistence:

Activation/exhaustion markers (PD-1, LAG-3, TIM-3 by flow).

Metabolic profiling (Seahorse assays for oxidative phosphorylation/glycolysis).

Antibody-Dependent Cellular Toxicity (ADCC) Services

Antibodies mark invader cells for destruction in the pathway termed Antibody Dependent Cellular Cytotoxicity (ADCC), which comprises part of the adaptive immune response. After an antibody coats the target cell surface effector cells, such as natural killer (NK) cells, bind the Fc portion of the antibody, causing the Fc receptors to be cross-linked and activating the effector cell. In vitro ADCC assays are the first step in evaluating the therapeutic potential of an antibody. SBH Sciences now offers ADCC assay services, based upon the Promega ADCC Reporter Bioassay™ technology.
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WHAT WE USE FOR THE MOST CONSISTENT RESULTS. The Promega ADCC Reporter Bioassay™ Technology

Traditional ADCC assays require donor peripheral blood mononuclear cells (PBMCs) as effector cells and typically monitor apoptosis by measuring the release of a radioactive marker. PBMC variability can lead to inconsistent results and the use of radioactive markers complicates safety. 

The Promega ADCC Reporter Bioassay™ uses engineered effector cells that stably express the FcϒRIIIa receptor, coupled to luciferase expression. Activated effector cells emit luminescence in the presence of Bio-Glo™ substrate. No donor cells or radioactive markers are needed. 

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Measurement of anti-CD20 activity on WIL-2S target cells using the Promega ADCC Reporter Bioassay™

Effector cells and target cells were mixed at a ratio of 6:1 (75,000 effector cells/well) and incubated for 6 hours at 370C. Bio-Glo™ reagent was added, and luminescence was measured using a Promega GloMax Multi Detection System™. A 70 fold induction of ADCC activity was detected at 1ug/ml α-CD20.

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Effector cells and target cells were mixed at a ratio of 12.8:1 (64,000 effector cells/well) and incubated for 6 hours at 370C. Bio-Glo™ reagent was added, and luminescence was recorded using a CLARIOstar BMG Labtech 96-well plate reader. Herceptin-treated cells showed a 57-fold increase in luminescent signal versus control wells at 0.5 ug/ml.

Antibody Drug Conjugate (ADC) Services

Antibody Drug Conjugates (ADCs) are monoclonal antibodies (mAbs) attached to cytotoxic / biologically active drugs by chemical linkers with labile bonds. By combining the unique targeting of mAbs with the cancer-killing ability of cytotoxic drugs, ADCs allows for sensitive discrimination between healthy and diseased tissue. With six marketed drugs(1), and 246 ongoing clinical trials(2), ADCs are presently recognized as a potent class of targeted anticancer therapies, with the potential to be used to treat a variety of other disease indications.
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ADC Services We Provide:

  • Mechanism of Action (cell proliferation, apoptosis)

  • Drug potency

  • Fc-mediated action (ADCC, Antibody-dependent phagocytosis)

  • Flow cytometry – internalization assay, cell cycle arrest assay

  • Lot Release and Stability Testing

  • Batch-to-batch comparability

  • Purity (SDS-PAGE/capillary gel electrophoresis, size-exclusion chromatography)

  • Stability (chromatographic and electrophoretic methods)

Antibody-Drug Conjugates (ADCs) Analytical Characterization Drug-to-antibody ratio (DAR) by HIC-HPLC Functional Potency Cell-killing mechanisms Proliferation inhibition (MTTXTT), apoptosis (caspas

ADC Analysis with Ligand-Binding Assays

Ligand Binding Assays (ELISA) are ideally suited for the bioanalysis of ADCs and their component parts (except for free drug). For pre-clinical or clinical sample (plasma or serum) analysis, we can provide:

  • PK/TK studies for ADCs

  • Immunogenicity assessment

  • Biomarkers

  • Long term stability

Immunogenicity Assessment

Immunogenicity refers to the ability of an antigen to induce an immune response. Proteins and antibodies, due to their structure and function, are often antigenic. This is particularly important for biotherapeutics as they are more likely to be recognized as foreign by the immune system, leading to the production of anti-drug antibodies (ADAs). SBH Sciences navigates the complexities of immunogenicity at all stages of the drug-discovery process by providing comprehensive immunogenicity testing services.
Immunogenicity_Assessment

T-Cell Based Immunogenicity Assays

This assay measures human T-cell activation following exposure to a potential drug. For this assay SBH uses PBMC from StemExpress, isolating the T-cells through negative selection using STEMCELL EasyStep Human T-Cell Enrichment Kit. In addition to using T-cells isolated from PBMCs, SBH has also used Jurkat E6-1 cells.

Activation markers such as CD69, CD25, CD4, and CD8 are analyzed using multiple platforms, including ELISA, Luminex and flow cytometry. See the data below of T-Cell Activation by CD3 and CD23 antibodies.

 

Services for Every Stage of Drug Development

In-Vitro Models

Designed to designed to predict the potential immunogenicity of proteins, antibodies, and other novel biologics, helping to anticipate how a new therapeutic may interact with the immune system.

Immune Response Evaluation

Conducted in pre-clinical models as well as clinical samples to assess how the immune system responds to a particular therapeutic, which is critical in understanding the safety and efficacy of biologics before moving into clinical trials.

SBH Sciences has the expertise to develop, qualify, and validate anti-drug antibody (ADA) methodologies. We have successfully developed ADA assays for several recombinant proteins, customized to our clients’ needs.In addition to traditional ELISA-based assays, we offer advanced cell-based assays to detect neutralizing anti-drug antibodies (NAbs). We develop direct and indirect assays, optimizing them based on the mechanism of action of the drug and leveraging our experience with target-specific cell-based assays. Our testing services also include the detection of NAbs in patient serum or plasma samples.To ensure the highest sensitivity and reproducibility, we optimize each assay to deliver reliable and precise results.As the world’s leading provider of cytokine cell-based assays, with over 350 assays currently available, SBH Sciences offers the necessary tools for a rapid and effective project timeline.
1. The six marketed ADCs are: (a) Brentuximab vedotin (Adcetris, Seattle Genetics, Millennium/Takeda),(b) Trastuzumab emtansine (Kadcyla, Genentech, Roche),(c) Inotuzumab ozogamicin (Besponsa, Pfizer/Wyeth),(d) Polatuzumab vedotin-piiq (Polivy, Genentech, Roche),(e) Enfortumab vedotin (Padcev, Astellas/Seattle Genetics),(f) Trastuzumab deruxtecan (Enhertu, AstraZeneca/Daiichi Sankyo) 2. According to ClinicalTrials.gov, Feb 25, 2020