De-Risking The Development Of Tomorrow's Medicines With Advancing Analytical Characterization Capabilities

Traditionally, regulatory submissions for biotherapeutics have relied heavily on a thorough understanding of the molecule's structural properties, along with any product-related or process-related impurities. However, this detailed characterization, often referred to as the molecule's "personality," can be even more valuable. Early evaluation of these attributes can not only guide decision-making throughout development but also aid in investigating unexpected results. As the field progresses and incorporates more complex biotherapeutics, like fusion proteins and bispecific molecules, new analytical challenges emerge. To deliver safe, compliant, and efficient next-generation medicines, an evolving analytical toolbox is essential. This presentation explores the advancements in mass spectrometry, biophysical characterization, automated sample preparation, and high-throughput analytics that are crucial for achieving these goals.

Key Takeaways:

• The rise of complex biotherapeutics necessitates advanced analytical techniques, moving beyond the traditional "platform" methods.
• Evaluating a biotherapeutic's "personality" throughout development is crucial, offering benefits beyond the data required for regulatory submissions.
• Gaining comprehensive product knowledge empowers efficient and robust process development by informing key decisions.