Meet the Expert: Ewoud van Tricht on A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development

Introduction

• Practical, stepwise implementation of ICH Q14 using AQbD tools
• Full method lifecycle approach: from Analytical Target Profile (ATP) and technology selection to control strategy and lifecycle management
• Efficient application of Design of Experiments (DoE) to identify and control critical method parameters
• Capillary electrophoresis (CZE) successfully replaced qPCR for adenovirus quantification
• All seven process intermediates were analysed by CZE within 30 minutes, without sample treatment
• Virus particle concentration is measurable at any production stage within 1 hour (previously 3–4 days)

Key Learning Outcomes

•  Shared challenge: Publications on Analytical Quality by Design usually highlight only fragments (e.g. analytical target profile or design of experiments) and practitioners struggle to implement the new ICH Q14 guideline in practice.
• Proposed solution: The authors distilled 50 years of combined experience into a structured nine-step workflow with practical tools, demonstrated on a complete real-life case from method request to use & improve.
• Community value: By offering a transparent, end-to-end example, the publication helps scientists translate regulatory guidance into practice and fosters harmonisation in analytical development and quality control.

About

Dr. Ewoud van Tricht has over 18 years of experience in the (bio)pharmaceutical industry. He has worked on small molecules, antibodies, proteins, viruses, and cell therapies at companies such as Abbott Healthcare Products, Janssen Vaccines, and Sanofi Cell Therapy. Alongside his full-time career, he completed a Bachelor’s, Master’s, and PhD in Analytical Chemistry. Ewoud specialises in Analytical Quality by Design (AQbD), having developed and implemented strategies to enhance pharmaceutical methods. He is passionate about optimising processes, coaching teams, and driving innovation through AQbD, Agile, and Lean methodologies, always striving for efficient and impactful results.

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