With the publication of ICH Q2(R2) and ICHQ14, the modern Quality by Design paradigm introduced by ICH Q8 for manufacturing is extended to Quality Control (QC). A life cycle, risk-based management approach is now encouraged where quality is built into analytical procedures. This so-called concept of Analytical Quality by Design (AQbD) demands a detailed understanding of all aspects of analytical procedures to further improve confidence and reliability of reportable values, ensuring product quality and ultimately patient safety.

This new, enhanced framework encourages living and agile procedure and calls for modern approaches and technologies. Nuclear Magnetic Resonance (NMR) align perfectly with these new concepts. By relying on universal and absolute principles, NMR can significantly simplify risk-assessment and streamline analytical procedure management. Its benefices from large method operable design region and it is one of the few technologies that allow leveraging the new concept of platform procedures, where testing quality attributes of several products without significant procedure changes is possible. Furthermore, qualifications and monitoring are simplified due to technology-inherent justifications.

This webinar will explore the benefices of using compact, cryogen-free, benchtop NMR for modern, AQbD-oriented QC procedures in both qualitative and quantitative applications. The development of agile yet simple NMR procedures for identification, one of the most performed tests, will be illustrated. Advantages of quantitative NMR (qNMR) for straightforward QC assays procedure development will be discussed through case studies on model drug products. Additionally, the implementation of more traditional compendial testing will be demonstrated. Finally, solutions for fully GMP-compliant testing will be presented, as a critical key for successful integration of benchtop NMR technology into QC laboratories.

Valentin Poirier, Ph.D.

Valentin Poirier holds a Ph.D. in chemistry from the University of Rennes, focused on organometallic catalysis and polymers. He then joined the pharmaceutical industry and pivoted to the analytical field, focusing on NMR and MS. Over the past decade, he managed the NMR and MS analytical platforms of CROs (Albhades, Evotec). As a technical expert, he contributed to dozens of analytical projects development for pharmaceutical applications and quality control. He joined Bruker BioSpin in 2024 as a Solution Product Manager in the Pharma Team. In this role, he collaborates with the pharmaceutical industry to advance NMR solutions tailored for Quality Control, Compliance and the CRO/CDMO customers.

Fabrice Moriaud, Ph.D.

Fabrice Moriaud, Ph.D. is Product Manager for GxP solutions. In his role as Solutions Development Manager at Bruker BioSpin, he brings extensive experience in leading the development of solutions for the Pharma industry. Trained as a chemist, Fabrice has a strong academic background in EPR and NMR.