Deploying NMR for the Product Characterization of Protein Therapeutics in Regulatory Submissions

Nuclear Magnetic Resonance (NMR) spectroscopy is a vital tool for analyzing protein structure and function. Unlike traditional biophysical methods, NMR enables the study of proteins in their natural and dynamic states with greater sensitivity and detailed information. 

This presentation will highlight current NMR techniques and compare them to conventional methods for characterizing protein therapeutics. Using NMR in regulatory processes strengthens drug characterization and supports adherence to regulatory standards. As biopharmaceuticals advance, NMR's role in drug development and approval will become increasingly important.

Key Learning Points

• Protein Therapeutics Characterization: Learn about how NMR methods used in comprehensive protein analysis are applied from early development through to market approval.
• Characterization of Protein Therapeutics in Regulatory Submissions: Explore how NMR deliver critical structural and functional data that can support regulatory filings, ensuring product quality and consistency.
• NMR in Regulatory Processes: Integrate the unique advantages of NMR to address challenging regulatory expectations and supporting successful filling of biopharmaceuticals.

What to Expect

• Gain practical insights into how Nuclear Magnetic Resonance (NMR) is advancing the characterization of protein therapeutics for regulatory submissions. This webinar will address how NMR based method can be used to support the detection and comparison of high order structure of protein therapeutics and report potential deviations.

Who should attend?

• This webinar is ideal for scientists and biopharma leaders working on protein therapeutics characterization, experts in biotherapeutics development and bioprocessing specialists. Anyone involved in advanced characterization techniques, including those involved in bioprocess development and/or those supporting regulatory filling will benefit from the session.

Presenter: Dr. Mats Wikstrom (Associate Director, Attribute Sciences, Amgen Inc.)

I possess extensive experience in research, development, and management within both academic institutions and the pharmaceutical industry. My career includes assignments at esteemed organizations such as Lund University (Sweden), the National Institutes of Health (NIH) (United States), Pharmacia and Upjohn Company (Sweden/United States), Biovitrum Company, Karolinska Institute (Sweden), University of Copenhagen (Denmark), and Amgen Inc (United States). Presently, I lead the Protein and Synthetics Characterization group at Amgen Inc, Thousand Oaks, United States, where my group provides structural characterization support for the development and marketing of Amgen’s synthetic and biopharmaceutical products.

Moderator: Dr. Martial Piotto (Pharma product manager of Biologics solutions)

Martial Piotto obtained his Ph.D. in NMR spectroscopy at the University of Purdue, USA (Pr. D. Gorenstein). He then joined Bruker France as head of NMR application where he worked on various aspects of NMR spectroscopy, notably the development of new pulse sequences and HRMAS technology. Over the years, he grew an interest in applications of NMR in the pharmaceutical and medical fields. His work currently focusses on the characterization of Biologics (mAb, vaccines and therapeutic oligonucleotides) by combining NMR and multivariate statistical tools.