“The whole nine yards of Biologics QA using NMR: Acquiring spectra, easy Processing, and Analysis”
We had a very exciting webinar about a hot topic in the NMR field, Higher Order Structure (HOS) analysis of biotherapeutic proteins. Dr. Donna Baldisseri (Bruker) described recently developed and optimized acquisition techniques. Dr. Mike Bernstein (Mestrelab) showed how data can be easily processed and analysed with the recently launched Mnova BioHOS plugin. Learn how to use this unique, single solution to ensure your NMR-based workflow for the Quality Analysis of biopharmaceuticals is accepted by regulators.
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High-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information on protein conformation, aggregation, stability, and modifications such as glycosylation. Effectiveness and ease of use in the study of the Higher Order Structure (HOS) of biotherapeutic proteins make this technique a uniquely valuable tool. Recently, new developments in acquisition and data analysis have emerged to establish NMR as a powerful metric for validating the HOS Critical Quality Attribute of intact molecules utilizing both 1D and 2D NMR methods.
Fast 1D fingerprinting methods will give a quick answer if the biologic is similar to the reference material. To identify changes at the amino acid level, 2D NMR methods are required. An interlaboratory comparison coordinated by NIST (26 labs involved, different magnetic fields, worldwide) demonstrated both high precision and high reproducibility of the 2D methyl fingerprint NMR method, which was further developed to include selective excipient signal removal. Optimization of acquisition and processing techniques will be presented which yield sensitive, high resolution 2D methyl fingerprint spectra of biotherapeutics in a few hours for fields 600MHz and above. High fidelity 2D methyl fingerprint spectra can be evaluated by multivariate analysis techniques to validate the HOS of biosimilars to reference product.
Powerful, effective software tools and proven algorithms come together to provide a robust combination for all important aspects of the data processing and analysis using Mnova. The software will be demonstrated to show its utility with the established fingerprinting and statistical analysis methods.
ABOUT THE SPEAKERS
In Applications at Bruker BioSpin, Donna has expertise in the fields of biomolecular NMR spectroscopy and in the application of high field cryo- and micro-probe technology.
Before joining Bruker BioSpin, Donna was an Associate Research Professor at the University of Baltimore Medical School studying the conformation and dynamics of proteins involved in neurodegenerative disease and olfactory sensing. She had a post-doctoral fellowship at NIH measuring the effect of mutations on the structure-activity of nucleases. Donna has co-authored over 25 articles in peer reviewed scientific journals.
Dr. Michael (“Mike”) Bernstein is responsible for R&D aspects of Mestrelab Research. Particular emphasis is on suitability for use by chemists, and developing capability around the use of NMR for quantitation.
He earned his B. Sc. (Hons.) at the University of Cape Town, majoring in Chemistry. This was followed by graduate studies at the University of British Columbia, where a Ph. D. was awarded in the area of Physical Organic Chemistry. This early interest in NMR was backed up with over 30 years of pharmaceutical experience with NMR first at Merck Frosst (MSDRL) in Montreal, and then at Astra Zeneca in the UK. He joined Mestrelab in 2011.