Meet the Expert: Anne Ries on Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

Introduction

• Introduces a universal study design to assess comparability when switching or updating pharmaceutical analytical instruments, ensuring compliance with GMP requirements.
• Demonstrates the approach with a benchmark study comparing ICE3 and Maurice C icIEF instruments, confirming equal or superior performance of the newer system across all evaluated parameters.
• Provides a science-based framework for seamless instrument updates, minimising the need for re-validation while maintaining robust release analytics over a product’s lifecycle

Key Learning Outcomes

• Shared challenge: Instrument updates in regulated environments are common, yet guidance is scarce, leaving many scientists to “reinvent the wheel”.
• Proposed solution: The study presents a practical, efficient, and broadly applicable design to assess instrument comparability, aligned with ICH guidelines.
• Community value: By sharing their benchmark results, the authors aim to inspire exchange and collaboration on lifecycle management challenges in quality control

About

Anne Ries joined Boehringer Ingelheim in 2022. She works on various lifecycle topics in pharmaceutical release analytics, focusing on innovation during the post-approval phase of a biopharmaceutical product. Anne aims for efficient and digital solutions, as well as public accessibility and exchange across companies. Anne holds a biochemistry degree from the University of Tübingen, Germany, and completed her PhD in structural biology at ETH Zürich, Switzerland.