The Chromatographic (Analytical) Method Life Cycle (2026): From Cradle to Grave (III)

Outside of major international symposia, the Chromatographic Society Spring Symposium remains the premier annual event for separation scientists in the UK. This year will be no exception, as the Chromatographic Society and the Joint Pharmaceutical Analysis Group (JPAG) jointly host a two-day meeting in the ongoing series: “The Chromatographic (Analytical) Method Life Cycle: From Cradle to Grave (III).” These meetings continue to grow in reputation, attracting an increasing number of European and Big Pharma experts, alongside major vendors showcasing their latest technologies.

Held at the prestigious RSC Burlington House in Central London, the event is accessible to both UK and European delegates, including newcomers considering attendance for the first time.

The Chromatographic Society (ChomSoc) consistently highlights cutting-edge topics generating excitement within separation science. The concept of the analytical lifecycle “from cradle to grave” was first introduced at this symposium in 2015, initially focused on biologics characterisation. Since then, meetings were held in 2018 and 2023, coinciding with the rise of FDA lifecycle thinking and the publication of ICH Q14. Now, three years later, it is timely to revisit this area to explore how lifecycle management is evolving.

The symposium aims to provide clear insights into successful strategies covering critical areas, including updates to ICH Q14 and ICH Q2, as well as other relevant guidelines such as the British Pharmacopoeia, JP chapters, and upcoming USP <1220>, <1221>, and <1225>. Topics span all stages of the analytical method lifecycle—from development and robustness assessment across techniques like liquid chromatography (LC), supercritical fluid chromatography (SFC), gas chromatography (GC), and capillary electrophoresis (CE), to qualification, validation, transfer, and continuous performance monitoring.

Focus will be placed on analytical lifecycle management in the pharmaceutical industry, reflecting the latest regulatory expectations including Analytical Quality by Design (AQbD) principles and permitted chromatographic method changes according to key pharmacopoeias. The meeting will also emphasize the holistic AQbD framework described in ICH Q14, covering elements such as the Analytical Target Profile (ATP), knowledge management, risk assessment, and performance monitoring. Discussions will explore balancing a risk-based approach with the benefits of post-approval flexibility against the resource demands of implementing these advanced strategies. Ultimately, the goal is to streamline analytical development, yielding well-understood methods and simplified lifecycle management.

The program will feature several case studies showcasing how pharmaceutical companies are implementing these advanced lifecycle concepts with a patient-centered and risk-based control strategy approach. Topics include aligning analytical procedures with product quality attributes while minimizing risks from future changes and their impact on overall product control strategies.

A comprehensive exhibition, fully integrated into the event, will highlight innovative predictive modeling and digital tools that support statistical expertise and forward-thinking analytical development.

The program is nearly finalized, with presentations from esteemed international speakers representing industry, regulatory agencies, and chromatography vendors. Some highlights include:

• “Regulatory State of the Nation for Analytical Lifecycle: Expectations, Concepts, and Future Directions” — Jean-Francois Dierick, GSK, Belgium
• “A Platform Approach to Charge Variant Analysis of Monoclonal Antibodies” — Sandra Furlanetto, University of Firenze, Italy
• “Retention Prediction for Green Methods” — Ilaria Neri, University of Cork, Ireland
• “Performance-Based Definition of Analytical Platforms Using Enhanced Approaches” — Dr. Gerald Gellerman, Novartis Biologics, Switzerland
• “Analytical Method Lifecycle as Part of Control Strategy” — Maire Welham, AstraZeneca
• “Separation Quality Factor: Ranking, Modeling, and Optimizing Gradient Separations” — Szabolcs Fekete, University of Geneva, Switzerland
• “ML (Bayesian) Method Optimization for Oligo Diastereomer Separations” — Matt Notley, AstraZeneca, UK
• “Digitalising the Analytical Method Lifecycle: An Industrial Use Case” — Stephanie Toulot, Novartis, Switzerland

…and many more.

This event offers something for everyone—from industrial scientists, academics, and students new to this lifecycle approach, to experts and practitioners eager to exchange knowledge and experiences.

Attendees will benefit from unique networking opportunities and real-world insights. ChromSoc student bursaries and other funding options are available.

For those interested in presenting flash posters, exhibiting, or discussing involvement, please contact Adrian Clarke at [email protected].

For further information

Bursaries: https://chromsoc.com/development/

Visit https://chromsoc.com/events/