Characterize Your Biologics with Smart and Science-driven Concepts
Analytical characterization is key for the successful drug product development of biologics. Independent of the modality, the ability to understand the molecule in its formulation, including container closure system, its degradation pathways and critical quality attributes (cQAs) is central for the development of high-quality drug products for human applications. While modalities continue to diversify, the underlying analytical questions often remain remarkably consistent.
Across proteins, antibody-based therapeutics, viral vectors and other complex biologics, we repeatedly encounter similar analytical challenges: How do we reliably detect, identify and interpret particles? How can surfactants be characterized in a way that is sensitive, selective, and truly fit for purpose, beyond simple concentration measurements? These are not modality-specific problems, but fundamental questions rooted in formulation science.
At the same time, each modality brings its own complexity. For example, for AAV based products, the characterization of full versus empty capsids is not merely an analytical exercise, but a critical determinant of product quality, safety, and efficacy. Addressing such questions requires tailored approaches, built on solid scientific understanding rather than purely procedural method development.
At Coriolis, we deliberately chose not to reinvent analytical methods for every new project. Instead, we established the science driven Coriolis COR-Competences® platform analytical approaches built on 18-years of experience in drug product development, academic and applied research projects and continuous learning. This allows us to address recurring challenges efficiently while maintaining the flexibility needed for modality specific questions. Particle identification workflows and advanced surfactant characterization are just two examples where a deep understanding of the underlying science enables better decision making.
In this webinar, Dr. Andrea Hawe – Chief Scientific Officer and Amber Raines – Senior Director of Client Project Management at Coriolis Pharma will illustrate practical examples where standardized, yet scientifically sound approaches add value to the analytical characterization of biologics and discuss the science behind these selected methods. Join us to explore how strategic analytical focus can accelerate drug product development without compromising depth, quality or innovation
3 challenges this content will address:
• How to choose phase-appropriate analytical methods
• Selecting the best panel of analytical assays for a specific modality
• Ensuring a suitable characterization package without disrupting aggressive development timelines
3 key learning objectives:
• Understand the role of analytical characterization in biologics DP development
• Recognize generally applicable versus modality specific analytical challenges
• Learn how science driven approaches improve analytical efficiency and quality
