Institute for International Research

Description

Immunoassays are a diverse set of bioanalytical tools that use antibodies and various assay formats for drug discovery, biopharmaceutical, biologics, vaccine, diagnostic, forensic, and environmental applications. The appropriate design and validation of immunoassays are critical to their successful use in the laboratory or for point-of-care testing.

Attendees will be taken through a structured approach for understanding, developing, and validating immunoassays. This course will cover antigen and antibody preparation and characterization to create immunoassays with the appropriate specificity and sensitivity. Various assay formats will be discussed for developing assays to meet testing, quality, and regulatory needs. Validation of immunoassays will be emphasized along with the use of controls and panels to confirm data quality. Case studies and group discussions will be used to expand the course content to participant's needs for implementation in the laboratory or field. Regulatory requirements for RUO, ASR, IVD, and CE mark will be reviewed.

Instructor

Larry S. Miller, Ph.D., Industry Consultant
Dr. Miller has held R&D senior leadership positions in biotech, drug discovery and development, and diagnostic companies. Dr. Miller has over 20 years experience in designing and validating immunoassay systems leading to patents and FDA approved immunodiagnostic kits at Abbott Laboratories, Battelle, Midwest Research Institute, Phylos, Cetek, and SeraCare Lifesciences. He received his undergraduate and graduate degrees from The Ohio State University and was a Research Fellow at Scripps Research Institute. Dr. Miller has 35 publications and 40 presentations at national and international research conferences in the areas of antibody-based testing for cancer, infectious diseases, histocompatibility, biomarkers, drug discovery, vaccines, laboratory automation, environmental monitoring systems, and advanced biosensor technology.

Course Agenda

• Immunoassay general principles
• Antibody structure
• Antibody specificity and affinity
• Immunoassay formats
• Immunochemical reagent preparation and characterization
• Labeling and detection systems including biosensors and integrated devices
• Multiplex, microarray, and nano- technologies
• Design goals and assay characteristics for intended use
• Immunoassay formats and conditions including Design of Experiments
• Immunoassay optimization for detection limit, LLOQ, ULOQ, curve fitting and statistical analysis
• Method development with considerations for sample, assay, detection, data analysis, and report
• Immunoassay development
• Method validation considerations for system suitability and regulatory guidelines
• Method revalidation, transfer and verification
• Quality control with review of control charts and Westgard Rules
• Assay validation considerations for repeatability and reproducibility
• Robustness and effects of sample matrix, dilution, interferants
• Studies for analytical specificity, reference method and clinical correlation, and stability testing
• Immunoassay troubleshooting
• Applications in drug development and biologicals, bioprocessing, vaccines, environmental analysis, and point-of-care testing