Bioassays & Bioanalytical Methods is a workshop dedicated to complex therapeutics such as biologics, biopharmaceuticals and biosimilars.
Topics
- Bioassays & Binding Assays - regulatory updates
- Introduction to Bioassays, Binding Assays and Bioanalytical Methods
- Characterization of biotherapeutics: requirements and challenges
- Bioassay development & qualification strategies
- Biological Assay Validation, Preparation & Performance
- Biostatistics for Bioanalytical Data Evaluation
- Principles and development of GCLP Bioanalytics
- Bioassays for Immunogenicity testing & ADA analysis
- Case studies: Selected bioassays under characterization & control
- Bioassays for characterization of monoclonal antibodies
Who should Attend
Attendees with job titles such as:
- Product Development Specialists (complex therapeutics)
- Protein Assay Developer
- Regulatory Managers / Specialists
- Analytical Chemists and Biochemists
- CMC Heads / Process Development Managers
- QC / QA Managers and Supervisors
- Product Stability Managers
- R&D Product Scientists
- Clinical Immunology Scientific Affairs
- Lead Analysts for Bioanalytical Method Development
- Qualified Persons
