CHI's Optimizing Bioassays for Biologics 2013

Key Topics

• New Technologies and Approaches to Bioassays
• Optimizing Bioassays for Biologics
• Development and Optimization of a Potency Assay for a 7 Component Peptide Drug
• Optimization of Ligand Binding Assay by Design of Experiment
• A Regulatory Perspective on Bioassays for Evaluation of the Quality of Protein Drug Products
• Reference Standards for Potency Assays – Future Directions
• A Statistical Approach to Bioassay Bridging and Transfer
• Compendial Potency Assays and Associated Biological Reference Materials – Challenges in Assay Transition and Unit Maintenance
• Evaluation of Processes for Reducing and Monitoring Assay Variability for Bioassays
• Regulatory-Compliant Validation of a Standardized ADCC Potency Assay
• Assay Development, Automation and De-Convolution of Multiplexed High Throughput Live-Cell Screens
• Bioluminescent NFAT-RE-luciferase Reporter Bioassay: A Novel Technology to Reduce Assay Variability in ADCC
• Functional Assays for Biosimilars: An Industry Perspective
• Special Considerations for Developing Cell-Based Immunogenicity Neutralizing Anti-Drug Antibody (NAb) Assays to Support Clinical Comparability Studies for Biosimilars
• Characterization Using a Surrogate Non Cell-Based Ligand Binding Assay
• Comparison of Cell-Based and Non Cell-Based Assay Platforms for the Detection of Anti-Drug Neutralizing Antibodies

Who should Attend

Attendess involved in

• Cell and antibody engineering
• Bioanalytical R&D
• Pharmacology
• Immunology
• Preclinical and clinical development