In the ever-changing biopharmaceutical industry, Bruker understands that there is an urgent need for high-resolution techniques for the comparability and similarity assessment of biologics and biosimilars. The Bruker and Optimal Teams welcome you to Booth 401 to meet with our experts in Nuclear Magnetic Resonance (NMR) and Process Analytical Technologies (PAT). And, don't forget to add our talk to your conference schedule:
Magnetic Resonance Multi-Attribute Methods for Biotherapeutics Characterization, PAT and QC
Track: Accelerating Analytical Development
Date: Wednesday, August 17
Time: 2:30 PM - 3:00 PM ET
Speaker: Kate Holub
Authors: Joan Malmstrøm1, Karl Ratzsch2 , Matteo Pennestri3 and Katherine Holub4*
1. CMC analytical support, R & D, Novo Nordisk A/S, Måløv, Denmark
2. Bruker BioSpin GmbH, Rudolf-Plank-Straße 23, 76275 Ettlingen, Germany
3. Bruker UK Ltd, Banner Lane, Coventry CV4 9GH, UK
4. Bruker BioSpin Corporation, 15 Fortune Drive, Billerica MA 01821
Nuclear magnetic resonance (NMR) is as an analytical technique recognized for being information rich and more sensitive towards changes when compared to other biophysical techniques used to address higher order structure (HOS) of biologics.1,2 Due to the quantitative nature of magnetic resonance and its selectivity, impurity profiling3 and degradation studies (e.g., polysorbates) are performed directly enabling fast and easy testing without the need of response factor calculations, or method redevelopment activities required by traditional LC methods, thereby saving time, and reducing costs. Although traditionally the use of magnetic resonance has been limited to R&D, recent solutions have removed the GxP obstacles in development and manufacturing, enabling NMR to move forwards in the biopharmaceutical value chain and to be included in late phase and on-market projects.
The introduction of compact, benchtop flow NMR instrumentation, integrated into PAT management software, makes NMR important also for (bio)process monitoring and bioproduction control.4 Time Domain NMR (TD-NMR), on the other hand, has the great advantage of being truly non-destructive, allowing the analysis of drugs in their container (vials and syringes) and maintaining the sterility of the product. This, together with the speed of the measurements, will enable 100% testing, required for highly potent drugs.
During this talk, we will show examples of the use of magnetic resonance for biologics and biosimilars analysis, from high field NMR in R&D5 to benchtop EPR, FT-NMR and TD-NMR in bioPAT and QC.
1. Arbogast L., Delaglio F., Tolman J.R., J Biomol NMR, 72: 149-161 (2018)
2. Haxhom G.W., Bent O., Malmstrom J., J Pharm Sci, 108: 3029 (2019)
3. Skidmore K, Hewitt D, Kao Y.H., Biotechnol Prog. 28(6):1526-33 (2012)
4. Bradley S. A., et al, J. Am. Chem. Soc., 132 (28), 9531–9533 (2010)
5. P. Rößler, D. Mathieu & A. Gossert, Angew. Chem. Int. Ed., 59, 19329 (2020)
To register, visit the Bioprocessing Summit website
Business Development Manager – Pharmaceutical Business Americas