Immunogenicity Of Biologics, Biopharmaceuticals & ATMPs

The Immunogenicity Of Biologics, Biopharmaceuticals & ATMPs is dedicated to practical & in-depth understanding of immunogenicity in pre-clinical and clinical development.

Topics

• Immerging into the field of immunology & immune reactions
• Guidelines, regulatory & quality requirements for immunogenicity
• Analytical development – screening, confirmation & neutralization assays
• Different factors which may impact immunogenicity
• Study design & bioanalytical methods as characterization tools
• Characterization and monitoring of ADAs with appropriate analytical tools
• Clinical development – pitfalls & challenges, strategies to avoid ADA formation
• Immunogenicity risk assessment & mitigation
• Case studies on mAbs, ATMPs & Biosimilars
• Clinical synopsis with special emphasis on immunogenicity

Who should Attend

• Product Development Specialists
• Clinical Trial Manager
• Analytical Development Heads
• CSO/COOs in Biotech Industry
• Members for Product Analytics
• Members of QC Departments
• Personal from CROs
• Clinicians & Principal Investigators
• Members of agencies & authorities
• R&D Scientists for complex drugs