About this event
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, our experts 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 webinar 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
Hosted by
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External speaker
Amber Raines Senior Director of Client Project Management @ Coriolis PharmaE
Amber Raines, Ph.D. is Senior Director of Client Project Management at Coriolis Pharma, U.S., where she leads strategic client partnerships and project execution across biologics development programs. She is an expert at particle characterization and identification of (bio)pharmaceuticals, with a strong scientific background in biophysical characterization, formulation, and analytical development for protein therapeutics. Previously, she served as Senior Director of Rapid Analytics at KBI Biopharma, overseeing biophysical and particle characterization centers of excellence, innovation in analytical technologies, and collaborations with organizations such as NIST, NIH, and AAPS. Dr. Raines has over 15 years of industry experience at companies including Amgen and Merck. She holds a Ph.D. in Chemical and Biological Engineering from the University of Colorado Boulder and is an inventor on a U.S. patent related to reducing immunogenicity in therapeutic proteins.
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External speaker
Andrea Hawe Chief Scientific Officer @ Coriolis PharmaE
Dr. Andrea Hawe is an expert in drug product development for biologics with a strong scientific background in protein formulation, surfactant and particle characterization, and lyophilization process technology. Andrea has published more than 80 peer-reviewed papers and book chapters. At Coriolis, Andrea is responsible for Science & Technology in close collaboration with Dr. Tim Menzen. She also leads the Coriolis Scientific Advisory Board. Andrea values Coriolis for the opportunity to work with our clients worldwide on developing very exciting and novel biopharmaceutical drug products. She is also passionate about creating a positive and motivating working environment where each team member’s contribution is encouraged to shape Coriolis Pharma’s future. Her background is as a pharmacist with a PhD in Pharmaceutical Technology from the LMU Munich. She joined Coriolis from the very beginning as a member of the founding team and has been supporting the company since 2008.
Coriolis Pharma
Accelerate and De-risk your Drug Development - Right from the StartCoriolis Pharma is the premier partner for drug product development, analytical services, and manufacturing services across a vast array of biological therapeutic modalities. We provide our services under both R&D and GMP conditions, always bearing in mind the optimal solution for you.
