E21-28: Protein Therapeutics Immunogenicity

One-Day Course
Tuesday, November 16; 8:30am – 5:00pm

Dr. Robert Dodge, Novartis, East Hanover, NJ

A key aspect of the development of protein therapeutics is the assessment of immune response during clinical development.  Many attributes of the drug product, such as API amino acid sequence, formulation excipients, and post-translational modifications have the possibility to affect the human immune response.  This course gives a basic understanding of the immune system, clinical development expectations, and regulatory requirements.  In addition, methodologies for bioanalytical assay design for testing and reporting immune responses are discussed as to aid to the understanding and interpretation of reported bioanalytical test results.

Biologics process development chemists, analytical scientists, and bioanalytical scientists interested in understanding fundamentals of immune responses to protein drugs, how immune response measurements are made and interpreted, and regulatory expectations during clinical development.


  1. Immunology
    a. Outline of adaptive and innate immune system
    b. Humoral immune (anti-drug antibody) responses
    c. General concept in the design of drugs to minimize immunogenicity
    d. Why biosimilars or molecules made with a new process may have altered immune responses.
  2. Assay methodology, Bioanalytical Testing.
    a. Lessons learned at each stage of drug development on immunogenicity of a therapeutic.
    b. Concepts in anti-drug antibody assay design
    c. Interferences in bioanalytical assays
  3. Regulatory Expectations
    a. Risk based immunogenicity development and testing concepts.
    b. Regulatory expectations in protein drug development for immunogenicity assessments.
  4. Bioanalytical Assay Validation for Immunogenicity Measurements
    a. Bioanalytical assay validation, detailed methodology and rational.
    b. Caveats surrounding test results and interpretations.

Dr. Rob Dodge has worked in the Pharmaceutical Industry  for over 20 years in both CMC manufacturing of Biologic therapeutics and regulated Bioanalytical testing of small molecule, protein drugs, biomarkers and novel molecular entities such as nucleic acids, cell therapy, and gene therapy products.  Rob started his professional career at Bristol-Myers Squibb in the Immunology Department of the Pharmaceutical Research Institute and then moving to the biologic drug development and characterization team.  Rob co-founded Princeton Bio Lab, a GLP/GMP-compliant contract research laboratory specializing in cell-based assays for protein therapeutics which was sold to Pharmanet, where Rob became the Director of Immunochemistry and Cell Biology.   Rob subsequently returned to Bristol-Myers Squibb where he was the Director of Bioanalytical Sciences Development leading a team of scientists developing LC/MS, LBA, and cell based functional bioanalytical assays for small molecules, biologics and novel molecular entities such as nucleic acids and gene therapy products.  Rob is currently at the Novartis Institutes for BioMedical Research.