Antibody Drug Development, Characterization & Immunogenicity Testing
RayBiotech offers comprehensive antibody drug development and characterization services to support biologic and biosimilar programs from early discovery through IND-enabling and clinical development. Our integrated CRO capabilities include antigen and protein production, in vitro assay development, epitope mapping, antibody production, and PK/PD analysis, with expanded support for Anti-Drug Antibody (ADA) and Drug Antibody (DA) immunogenicity testing.
Our comprehensive analytical services are performed under CLIA-, GCLP-, GLP-, and cGMP-aligned quality systems, ensuring compliance with current regulatory guidance and industry standards for bioanalytical and immunogenicity testing.
Anti-Drug Antibody (ADA) testing is used to detect immune responses generated against therapeutic antibodies or protein drugs. ADA formation can affect drug safety, pharmacokinetics, and efficacy, making immunogenicity assessment a critical component of biologic drug development from preclinical studies through clinical trials.
ADA assays are designed to detect host-generated antibodies directed against a therapeutic drug. Drug Antibody (DA) assays are designed to monitor the level of drug antibody and may be used more broadly to characterize antibody responses to a drug, depending on study context. RayBiotech supports both ADA and DA immunogenicity workflows, including screening, characterization, and functional assessment.
RayBiotech supports a comprehensive, tiered ADA testing strategy, including ADA and DA screening assays, confirmatory assays to assess specificity, and titration assays to evaluate response magnitude. Assay formats are selected using fit-for-purpose bioanalytical strategies based on molecule characteristics and development stage.
RayBiotech employs a broad range of in vitro analytical methods, including flow cytometry, ELISA-based formats, western blotting, multiplex detection platforms, and cell-based functional assays. Methods are selected to ensure scientific relevance, adequate sensitivity, and compatibility with regulatory expectations for bioanalytical and immunogenicity studies.
Yes. RayBiotech operates under CLIA-, GCLP-, GLP-, and cGMP-aligned quality systems, supporting regulated bioanalytical, immunogenicity, and clinical programs in accordance with current regulatory guidance, including expectations from FDA and global regulatory agencies.
Yes. RayBiotech offers GMP-certified custom protein production services, including recombinant antigens and drug reagents used in ADA screening, confirmatory, titration, and neutralizing antibody assays. These services support IND-enabling and clinical-stage studies requiring consistency and traceability.
RayBiotech provides peptide-based epitope mapping arrays using overlapping, chemically synthesized peptides spanning the protein of interest. This approach enables high-resolution identification of antibody binding regions and supports antibody and vaccine development, ADA binding characterization, B-cell epitope mapping, and autoantibody and immune profiling studies.
Yes. RayBiotech provides custom monoclonal and polyclonal antibody production services, including antigen design, immunization, titer analysis, hybridoma generation or serum collection, antibody purification, and bulk scaling. Downstream services include antibody conjugation, lyophilization, custom vialing and aliquoting, and validation by western blot, ELISA, or immunoprecipitation.
RayBiotech integrates ADA results with pharmacokinetic and pharmacodynamic analyses to assess the impact of immunogenicity on drug exposure and efficacy. PK studies can be used to monitor drug absorption rate, drug distribution, drug elimination, and drug immunogenicity. PD studies include flow cytometry–based receptor occupancy assays that quantify free, occupied, and total receptor levels, as well as cell-based toxicity and efficacy testing to support exposure–response evaluation.
RayBiotech supports antibody drug development at any stage from early discovery and lead optimization through IND-enabling and clinical-stage bioanalytical studies, including biosimilar and comparability programs.
You can contact us at techsupport@raybiotech.com to discuss your molecule, development stage, and study objectives. Our experts will recommend a fit-for-purpose immunogenicity strategy aligned with your regulatory and timeline requirements.
High-quality antigens, proteins, and drug reagents are essential for antibody characterization and immunogenicity assessment. RayBiotech provides custom antigen and protein production services, including GMP-certified protein manufacturing, to support antibody drug development, bioanalytical assay development, and ADA and DA immunogenicity testing.
Capabilities include:
Recombinant protein and antigen expression
GMP-certified custom protein production for regulated and clinical programs
Antibody drug and protein reagent preparation
Purification and biochemical characterization
Lot-to-lot consistency testing and quality control
Reagent support for in vitro assays and immunogenicity studies
Our GMP-aligned protein production services ensure consistency, traceability, and quality for use in ADA screening, confirmation, titration, and neutralizing antibody assays, supporting IND-enabling and clinical-stage bioanalytical studies.
High-quality antigens, proteins, and drug reagents are essential for antibody characterization and immunogenicity assessment. RayBiotech provides custom antigen and protein production services, including GMP-certified protein manufacturing, to support antibody drug development, bioanalytical assay development, and ADA and DA immunogenicity testing.
Capabilities include:
Recombinant protein and antigen expression
GMP-certified custom protein production for regulated and clinical programs
Antibody drug and protein reagent preparation
Purification and biochemical characterization
Lot-to-lot consistency testing and quality control
Reagent support for in vitro assays and immunogenicity studies
Our GMP-aligned protein production services ensure consistency, traceability, and quality for use in ADA screening, confirmation, titration, and neutralizing antibody assays, supporting IND-enabling and clinical-stage bioanalytical studies.
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.
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.
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.
