2026 AQbD Symposium - Day 2 - Biopharmaceutical
2026 AQbD Symposium Day 2 - Biopharmaceutical
Staying ahead of regulatory change is a challenge. Evolving guidelines like ICH Q14, Q2(R2), USP <1220>, and the upcoming ICH M4Q(R2) and USP <1225> are reshaping expectations for analytical methods. Risk management and fit-for-purpose principles are now critical for compliance. Join us to explore how Analytical Quality by Design (AQbD) can help you design robust methods, streamline transfers, and meet today’s stringent small molecule and biopharmaceutical requirements.
Why Attend:
- Learn how to apply AQbD principles to the development of robust, risk-based analytical procedures.
- Use DoE tools to identify risks during method transfer and migration.
- Gain practical insights from industry experts on case studies to improve analytical testing reliability.
Agenda
Incorporating Analytical Quality by Design in Early Phase Development of mAbs and ADCs
- Mark Eggink, Principal Scientist, Analytical Development and Quality Control, Byondis
Application of Analytical Quality by Design Principles to the Analysis of Nucleic Acids using an Innovative Dual Gradient Approach
- Ricardo Gonçalves, Senior Analytical Scientist, Hovione
Leveraging AQbD Principles for Efficient Development of a Targeted Assay Method for Routine Monitoring of Mannose-5 Glycans Using Fluorescence Detection
- Pawel Bigos, Senior Scientist, Waters Corporation
Presenter: Mark Eggink, Ph.D. (Principal Scientist, Analytical Development and Quality Control, Byondis)
Mark Eggink, PhD, is Principal Scientist at Byondis, where he is responsible for analytical support for process development, method development and validation, batch release and stability testing of monoclonal antibodies and antibody drug conjugates.
Presenter: Ricardo Gonçalves (Senior Analytical Scientist, Hovione)
Presenter: Udayabagya (Bud) Halim (Sr. Marketing Analyst, Waters Corporation)
Bud Halimis a senior marketing analyst at Waters | Wyatt Technology with a PhD in physical chemistry from UCLA. He began his career teaching biochemistry and chemistry and contributing to laboratory manuals before transitioning into the scientific instrumentation industry as an applications scientist. At Waters, he supports researchers in the characterization of peptides, biologics, lipid nanoparticles (LNPs), and viral vectors.
