Shifting The Future Of Drug Development With Advanced Analytical Characterization

Regulatory submissions have long required a comprehensive understanding of a biotherapeutic molecule's structure, along with product and process-related impurities. Proactive characterization of these attributes, the molecule's "personality," is now crucial throughout development, guiding decisions and resolving anomalies. The increasing complexity of biotherapeutics, like fusion and bispecific proteins, demands advanced analytical tools. This presentation explores the latest advancements in mass spectrometry, biophysical characterization, automated sample preparation, and high-throughput analytics, essential for the safe, compliant, and efficient development of future medicines.

Key Learning Objectives:

• Understand how complex biotherapeutics necessitate specialized analytics beyond traditional platform methods.
• Recognize the value of early and continuous "protein personality" assessment beyond regulatory requirements.
• Appreciate how enhanced product knowledge drives informed decisions and streamlines process development.