MONDAY, OCTOBER 26
Pre-conference workshop
Technical Advice on Assay Development, Validation and Sample Analysis
Course Leaders:
Boris Gorovits, Ph.D., Director, Bioanalytical R&D, Wyeth and
Ana Menendez, Ph.D., Senior Director Biotechnology, Catalent Pharma Solutions
8:00am Workshop Registration
8:30am – 12:30pm
An interactive workshop to enable attendees to work out an immunogenicity
pre-clinical and clinical testing protocol for their particular therapeutic protein. Recent advances will be presented and areas of difficulty will be addressed. Delegates are encouraged to contribute with their own experiences and to
bring questions for discussion.
The following topics will be covered:
Immunogenicity risk assessment
The immune response and the nature of antibodies
Classification of biological drugs into distinct risk categories
Role of neutralizing antibodies
Determination of the immunogenicity risks for a given biological
Measurement of immunogenicity
Screening
Confirmation
Neutralization
Characterization
Assay methodologies and comparison of the methods
Critical issues in assay validation
Guidelines and White paper recommendations on validation strategy
Assay cutpoint determination
Problems to anticipate
Low-affinity antibodies: what is their significance from a clinical point of view and how do you deal with them?
How is validation done without a specific positive control?
How do you deal with interfering drug?
Other factors which can cause interference
Positive controls and assay sensitivity
Interpretation of results
Development of cell-based neutralizing antibody (Nab) assays
Application step to discuss sample analysis and any relevant issues
Discussion, questions and answers
For more information, please contact:
Nicole Lyscom, Ph.D.
Conference Producer
Cambridge Healthtech Institute (CHI)
Phone: +44-1483-826359
E-mail: nlyscom@healthtech.com
For sponsorship information, please contact:
Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: +1-781-978-5457
Cell: +1-857-636-2334
Email: iquigley@healthtech.com