A Q&A On Immunogenicity And Immunotoxicity Testing Challenges: De-Risk Your Early Drug Development

Issues with safety are one of the leading factors for clinical failure in the early stages of drug development.¹ When a drug candidate triggers an unwanted immune response, there can be a significant impact on time and resources on the path to market and, most importantly, can prevent the drug from reaching its targeted patient population. Human cell based in vitro assays can address the limited relevance of in vivo animal studies with biotherapeutic drugs and provide a potentially more human relevant risk assessment; however, using them successfully requires effective study design, data interpretation and experience from an expert team.

Noel Smith Ph.D., Head of Immunology at Lonza, recently presented the webinar, The good, the bad, and the ugly: How does identifying and mitigating potential for immunogenicity and immunotoxicity de-risk and accelerate your drug development? In it, Dr. Smith discussed how to overcome challenges with immunogenicity and immunotoxicity assessments in drug development and what tools are available to do so. He also reviewed case studies highlighting effective immunosafety assays as well as Lonza’s success in utilizing them as they apply their experience to help guide their clients’ drug candidates to FIH studies. This Q&A offers additional insight from Dr. Smith on common questions about this topic as well as addressing several questions asked during a discussion after the webinar.