The Immunogenicity Of Biologics, Biopharmaceuticals & ATMPs is dedicated to practical & in-depth understanding of immunogenicity in pre-clinical and clinical development.
The Immunogenicity Of Biologics, Biopharmaceuticals & ATMPs covers topics such as:
- 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
The Immunogenicity Of Biologics, Biopharmaceuticals & ATMPs brings together:
- 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
