Emerging Tools for the Analysis of Biologics and Biosimilars

In this virtual roundtable, experts explore the uses of nuclear magnetic resonance (NMR) in the analysis of biologics and biosimilars and discuss how recent advances are changing the game.

High-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. However, its application for the characterisation of biotherapeutic drugs in the pharmaceutical industry has been limited by it being difficult to use, expensive, size limited and to requiring labelled molecules, which all lead to lengthy studies.

In this virtual roundtable our experts discussed how recent advances in acquisition and analysis have changed the situation and now allow for the visualisation of whole antibodies at natural abundance. Thus, making NMR ideally suited for similarity assessment of biologics and biosimilars, as well as enabling evaluation of the structure of therapeutic drugs, without modification, in physiologically relevant conditions.

Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) also explained how, because of its intrinsically high information content, NMR has the potential to reduce the number of techniques needed to characterise therapeutic drugs, thereby saving time and reducing costs.

They also reviewed the current applications of magnetic resonance for the analysis of biotherapeutic drugs, including NMR, electron paramagnetic resonance (EPR) and time domain nuclear magnetic resonance (TD-NMR).

Wednesday 03 November 2021

07:00 AM CET

• Biologics and biosimilars are complex multi-attribute drugs with many features that can impact their function. Learn why the adoption of state-of-the-art high-resolution techniques (such as NMR and MS) is critical to increase product knowledge and decrease risks.
• Find out how the latest generation of NMR instrumentation, combined with newly developed NMR acquisition methods, enable the study of intact molecules, including antibodies (150 kDa), at natural abundance in formulation buffer or other physiologically relevant conditions.
• Understand why NMR is a powerful technique for the biologics and biosimilars development, formulation and stability with multiple applications such as high order structure, excipient-protein interaction, impurity profiling and force degradation and bioproduction analytics.
• Discover how TD-NMR, ‘benchtop relaxometry’, can be use as a QC technique for a ‘go’ or ‘no go’ answer to critical questions such as protein aggregates in vaccines and accurate fill check of vials and syringes.