Industry practices in immunogenicity assessment are becoming more unified though challenges still exist in terms of technology and reduction to practice. This conference aims to review key aspects of assay development and validation as well as to discuss challenges in implementation of these assays, data interpretation and relevance to clinical outcomes. The current knowledge and future trends of immunogenicity of therapeutic proteins will also be explored.

FEATURED TOPICS
• Current practices in immunogenicity evaluation
• Role of preclinical assessment
• Challenges of clinical immunogenicity assessment: case studies
• Risk assessment and risk management
• Regulatory perspectives
• Future of immunogenicity assessment