The implementation of new, efficient and adapted analytical procedures is a pressing need for the development and release of innovative new pharmaceutical products to ensure their efficacy and patient safety. The growing interest in complex drug modalities (small molecules, Biologics, ATMPs) demands ever more sophisticated analytics, while the rapidly evolving regulatory landscape calls for more advanced, technology- and data-driven approaches. This transformation involves all actors of the biopharma industry, from major pharmaceutical companies to CDMO and testing laboratories. New, agile, sustainable and integrated QC solutions are required to address these new challenges without compromising efficiency.
Tuesday, 18 March 2025
5:00 PM CET
Webinar Overview
With the recent regulatory emphasis on deep analytical procedure understanding and life cycle management promoted by the Analytical Quality by Design framework, a shift from traditional quality control (QC) procedures to modern analytical approaches and technologies is required.
While placing a strong focus on robustness and risk management, the recent ICH Q14 and revision R2 of ICH Q2 also introduce the concept of platform procedures, formally allowing flexibility and agility in the management of analytical procedures. Among these modern technologies, Nuclear Magnetic Resonance (NMR) stands out, able to address multiple needs, from raw material testing to finished products with inequivalent robustness and transferability.
By relying on universal and intrinsically quantitative principles, NMR allows straightforward development and risk management, while technology-inherent justifications enable simplified validation, as highlighted in ICH Q2 (R2).
What to Expect
Learn how NMR provides modern and robust solutions for QC, from early development to manufacturing environment. Discover how GMP-compliant end-to-end solutions based on NMR can address a wide range of qualitative and quantitative applications, from raw material testing to the control of critical quality attributes of high-value finished products, constituting an attractive alternative to traditional technologies.
Key Learning Points
- Modern QC labs need advanced, integrated solutions to handle complex drug analytics and evolving regulations efficiently.
- New regulatory framework introduced with ICH Q14 and Q2 (R2) emphasizes robust yet flexible QC procedures, requiring technologies like NMR for effective risk management and validation.
- GMP-compliant NMR solutions offer robust, versatile QC applications, from raw material testing to high-value product quality control.
Who Should Attend
- Innovation or scientific directors, analytical science experts and QC laboratory managers exploring new analytical solutions to solve their current analytical challenges, and address evolving regulatory requirements.
- Analytical scientist involved in CMC and QC procedure development and implementation seeking to discover how NMR can streamline their development and validation workflows.
- Scientist involved in regulatory affairs learning about implementation of modern QC technologies to fit recent regulation.
Speakers
Frédéric Girard, PhD.
Senior Director BioPharma Business Unit, Bruker Biospin
Frédéric is a chemist by training and holds a PhD in Molecular Biophysics from the University of Orleans / CNRS. He has been an entrepreneur in the analytical R&D and testing industry for over 20 years, serving the biopharmaceutical sector. He founded Spinnovation Analytical in 2004, which was acquired by Eurofins in 2016. Besides analytical sciences, he has strong experience with GMP and environmental management systems. From 2016 to 2024, he was the managing director for Eurofins Spinnovation, and in 2020, he also joined the Senior Scientific Director program of Eurofins BPT Europe, covering the scope of NMR and solid-state characterization. He joined Bruker BioSpin at the end of 2024 as Senior Director for the Biopharma Business Unit, managing the biopharma market with the support of a team of solution product managers.
Dr. Valentin Poirier
Solutions Product Manager BioPharma, Bruker BioSpin
Valentin 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, with a customer-centric and problem-solving approach. 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.