The development and release of pharmaceutical products require the use of modern, efficient, and adaptable analytical techniques to assure efficacy and patient safety.
The growing interest in complex pharmacological modalities (small molecules, biologics, and ATMPs) calls for increasingly sophisticated analytics, while the quickly evolving regulatory landscape necessitates more advanced, technology- and data-driven approaches.
This shift affects all biopharma industry participants, including large pharmaceutical companies, CDMOs, and testing laboratories. To handle these new challenges while remaining efficient, new, agile, sustainable, and integrated quality control (QC) solutions are necessary.
Webinar overview
The Analytical Quality by Design framework's new regulatory emphasis on deep analytical procedure understanding and life cycle management requires transitioning from traditional QC techniques to modern analytical methodologies and technologies.
While emphasizing robustness and risk management, the recent ICH Q14 and revision R2 of ICH Q2 include platform procedures, which formally allow for flexibility and agility in managing analytical operations.
Among these current technologies, Nuclear Magnetic Resonance (NMR) is known for its unparalleled robustness and transferability, allowing it to meet various applications, from raw material testing to final products.
NMR enables straightforward development and risk management by focusing on universal and intrinsically quantitative principles, while technology-inherent justifications allow for simplified validation, as stated in ICH Q2 (R2).
What to expect
Discover how NMR provides modern and robust QC solutions, from early development to manufacturing environments.
Discover how GMP-compliant end-to-end NMR solutions can address various qualitative and quantitative applications, from raw material testing to controlling critical quality attributes in high-value finished products, making them an appealing alternative to traditional technologies.
Key learning points
- Today's QC labs require advanced, integrated solutions to manage complex drug analysis and keep pace with changing regulatory demands.
- The updated regulatory guidelines under ICH Q14 and Q2 (R2) stress the need for quality control processes that are both rigorous and adaptable—making technologies like NMR essential for thorough risk assessment and method validation.
- GMP-compliant NMR solutions support a wide range of QC tasks, from raw material verification to the quality assurance of high-value pharmaceutical products.
Who should attend
- Innovation or scientific directors, analytical science experts, and QC laboratory managers seeking novel analytical solutions to address current issues and regulatory needs.
- Analytical scientists interested in using NMR to expedite CMC and QC method development and validation workflows.
- Regulatory affairs scientists interested in implementing current QC technologies to comply with new regulations.
Speakers
Frédéric is a trained chemist and has a PhD in Molecular Biophysics from the University of Orleans/CNRS. He has been an analytical R&D and testing entrepreneur for over 20 years, mostly serving the biopharmaceutical sector. He established Spinnovation Analytical in 2004, which was acquired by Eurofins in 2016.
In addition to analytical sciences, he has extensive experience with GMP and environmental management systems. He was the managing director of Eurofins Spinnovation from 2016 to 2024, and in 2020, he joined Eurofins BPT Europe's Senior Scientific Director program, which focused on NMR and solid-state characterization.
He joined Bruker BioSpin at the end of 2024 as Senior Director for the Biopharma Business Unit, where he manages the biopharma market alongside a team of solution product managers.
Valentin joined Bruker BioSpin in 2024 as a Solution Product Manager in the BioPharma team. In this role, he collaborates with the pharmaceutical industry to advance Nuclear Magnetic Resonance solutions tailored to drug development and manufacturing, with a strong emphasis on quality control and compliance. A trained chemist, he entered the pharmaceutical industry after completing his Ph.D. Over the past decade, he has managed analytical platforms at CROs (Albhades and Evotec), focusing on NMR and Mass Spectrometry as modern tools for analytical sciences and regulated applications (GMP/GLP). As a technical expert, he has contributed to the development of dozens of analytical projects for pharmaceutical applications and quality control, with a customer-centric and problem-solving approach.