Bioassays & Bioanalytical Methods

Bioassays & Bioanalytical Methods is a workshop dedicated to complex therapeutics such as biologics, biopharmaceuticals and biosimilars.

Key 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