The Importance Of Assessing And Mitigating Immunogenicity Potential

By Noel Smith, Ph.D., and Yvette Stallwood, Ph.D.

While the reasons for clinical failure vary, a large portion is due to issues with safety and efficacy. Unwanted immunogenicity can have severe consequences for patients, this is why understanding the potential immunogenicity and immunotoxicity of your candidate is a regulatory requirement to support your first-in-human program. As the biopharmaceutical developer, it is your responsibility to ensure you have adequately assessed the possibility of your drug candidate eliciting an unwanted immune response. Unfortunately, immunogenicity assessment is also an area where "standard" in vivo toxicology assessments might lack clinical relevance. To overcome this challenge, read our E-Book and get an expert view on the challenges of early immunosafety assessment and available risk mitigation strategies.