Antibody Drug Development, Characterization & Immunogenicity Testing

RayBiotech develops and performs in vitro assays and screening services to evaluate antibody binding, specificity, bioactivity, and immunogenicity risk.

Our assay capabilities support:

• Flow cytometry–based assays for cell-surface binding, receptor engagement, and immune response characterization
• Sandwich and direct ELISA assays for antibody binding and quantitative bioanalysis
• Western blotting for antibody specificity, target validation, and confirmatory assessments
• Multiplex detection platforms for simultaneous measurement of multiple targets, immune markers, or pathway components
• Functional in vitro testing, including cell-based bioactivity and mechanism-of-action assays
• ADA and DA screening assays to detect immune responses against therapeutic antibodies and protein drugs

Assays may be developed for exploratory, fit-for-purpose, or validated use depending on study requirements.

Epitope mapping provides valuable insight into antibody–antigen interactions. RayBiotech offers peptide-based epitope mapping array services to identify antibody binding regions at high resolution. Peptide arrays are prepared by printing overlapping, chemically synthesized peptides (>95% purity) spanning the full length of the protein of interest. Each peptide is printed in replicates onto a glass slide surface in an arrayed format, enabling comprehensive coverage and reproducible detection.

Purified antibodies or biological samples containing antibodies (e.g., serum or plasma) are incubated on the peptide arrays, during which antibodies specifically bind to peptides containing their sequence of interest. A biotin-conjugated secondary antibody (e.g., anti-human IgG or anti-mouse IgG), followed by a fluorescently labeled streptavidin, is used for detection. Fluorescent signals are captured and analyzed to identify peptide sequences bound by antibodies, allowing potential epitopes to be mapped and characterized.

Applications include:

Antibody and Vaccine Development

• Identification of antigenic epitopes for antibody and vaccine development
• Definition and comparison of antibody clones to identify the best-performing antibody against the protein of interest
• Epitope mutant analysis to assess sequence–function relationships and binding specificity

Immunogenicity and ADA Characterization

• Characterization of ADA binding regions on therapeutic antibodies
• Differentiation of neutralizing versus non-neutralizing antibody responses
• Support for immunogenicity risk assessment and mitigation strategies

Autoimmunity and Immune Profiling

• Localization of (auto)antigen epitopes recognized by (auto)antibodies
• Mapping of B-cell epitopes to support immune profiling and immune response characterization

Our high-resolution epitope mapping approach strengthens understanding of immune responses, therapeutic performance, and functional relevance, supporting both discovery and regulated development programs.

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RayBiotech provides custom antibody production services, including monoclonal and polyclonal antibodies, to support antibody characterization, assay development, and bioanalytical testing.

Core Antibody Production Workflow

Our end-to-end antibody production process includes:

• Antigen design, including phospho-specific and custom-modified antigens
• Antigen synthesis and carrier protein conjugation
• Immunization using optimized protocols
• Titer analysis to assess immune response and specificity
• Serum collection or hybridoma fusion, depending on antibody format
• Antibody purification for downstream applications

Scale-Up, Characterization, and Quality Testing

In addition to antibody generation, RayBiotech offers bulk-scale monoclonal antibody production using carrier-free or serum-containing systems, tailored to downstream and regulatory requirements.

Supporting services include:

• Bulk antibody scale-up
• Endotoxin testing
• Isotyping and purity assessment
• Neutralization and functional evaluation

Customization, Formulation, and Validation

Following production—or as standalone services—RayBiotech provides flexible downstream options to ensure antibodies are application-ready and study-compatible, including:

• Antibody conjugation to fluorophores, oligonucleotides, biotin, etc.
• Lyophilization
• Custom vialing and aliquoting
• Antibody validation by Western blot, ELISA, or immunoprecipitation

These services ensure antibodies are fully characterized, application-ready, and compatible with regulated bioanalytical and immunogenicity studies.

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Understanding how therapeutic antibodies behave in vivo is critical for development success. RayBiotech supports pharmacokinetic (PK) and pharmacodynamic (PD) studies, with integrated evaluation of ADA impact on drug exposure, clearance, and efficacy.

PK/PD support includes:

• PK assay development for antibody therapeutics
• Measurement of drug concentration, exposure, and clearance
• Correlation of ADA status with PK profiles
• Integration of neutralizing antibody data with PD endpoints
• Flow cytometry–based receptor occupancy (RO) assays to quantify free, occupied, and total receptor levels
• In vitro cell-based toxicity assays to assess drug safety and dose–response relationships
• Functional in vitro efficacy testing to evaluate pharmacological activity

This combined approach enables data-driven decision-making throughout preclinical and clinical development.

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