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Webinar – Biologics HOS (Higher Order Structure)

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“The whole nine yards of Biologics QA using NMR: Acquiring spectra, easy Processing, and Analysis”

[/vc_column_text][vc_column_text]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.

Fill in the form below to watch the recorded session on-demand![/vc_column_text][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner width=”1/3″][vc_icon icon_fontawesome=”fa fa-user” color=”custom” background_style=”rounded” background_color=”custom” size=”xs” align=”center” custom_color=”#ffffff” custom_background_color=”#b20e10″][vc_column_text css=”.vc_custom_1568913647889{margin-top: -30px !important;}”]

SPEAKERS
Dr. Donna Baldisseri &
Dr. Mike Bernstein

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DATE
Tuesday, October 8th

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TIME
11.00am (EST) / 5.00pm (CEST)

[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner el_class=”hidden”][vc_column_inner][vc_empty_space][ult_buttons btn_title=”REGISTER HERE!” btn_link=”url:%20https%3A%2F%2Fattendee.gotowebinar.com%2Fregister%2F897421792236091651||target:%20_blank|” btn_align=”ubtn-center” btn_size=”ubtn-block” btn_title_color=”#ffffff” btn_bg_color=”#b20e10″ icon=”none” icon_size=”24″ icon_color=”#ffffff” btn_icon_pos=”ubtn-sep-icon-at-left” btn_font_size=”desktop:20px;” btn_font_style=”font-weight:bold;”][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_separator][vc_empty_space][ult_buttons btn_title=”Watch the recorded session here!” btn_link=”url:http%3A%2F%2Fwww2.mestrelab.com%2Fl%2F271522%2F2020-06-02%2Fxx5jb||target:%20_blank|” btn_align=”ubtn-center” btn_size=”ubtn-block” btn_title_color=”#ffffff” btn_bg_color=”#b20e10″ icon=”none” icon_size=”24″ icon_color=”#ffffff” btn_icon_pos=”ubtn-sep-icon-at-left” btn_font_size=”desktop:24px;” btn_font_style=”font-weight:bold;”][vc_separator][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row css=”.vc_custom_1501066868084{background-color: #e2e2e2 !important;}”][vc_column][vc_column_text]

ABSTRACT

[/vc_column_text][vc_column_text]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.[/vc_column_text][vc_empty_space][vc_single_image image=”8046″ img_size=”large” alignment=”center” onclick=”link_image”][/vc_column][/vc_row][vc_row css=”.vc_custom_1565221006259{background-color: #e2e2e2 !important;}” el_class=”hidden”][vc_column width=”1/2″][vc_column_text][/vc_column_text][vc_single_image image=”7117″ img_size=”400×200″][vc_column_text][/vc_column_text][vc_single_image image=”6991″ img_size=”800×400″][vc_column_text][/vc_column_text][/vc_column][vc_column width=”1/2″][vc_empty_space height=”16px”][vc_column_text]Mnova Suite Basic is the top class software suite to process analytical chemistry data.  Mnova is a multivendor software suite designed for combined NMR, LC/GC/MS and Electronic & Vibrational Spectroscopic techniques.

In this webinar we will showcase the new version Mnova 14 Suite Basic, its many new features and the integration of a new module for Electronic and Vibrational Spectroscopies (ElViS). During this webinar you will learn how to open, view, process, analyse, report and predict NMR and MS data, as well as various electronic and vibrational spectroscopic techniques.

With the new product Mnova ElViS, our plugin for Electronic and Vibrational Spectroscopies, you will be able to carry out the analysis of various optical spectroscopy data including ultraviolet and visible (UV/Vis), near and mid infrared (NIR/MIR), Raman, fluorescence, and other spectroscopic methods operating in the whole region of wavelength from 100 nm to 100 µm.

We will show you how we can help with your compliance requirements thanks to the addition of Digital signatures to create identities & sign documents with them and Audit trail to track and report any processing operation carried out on your Mnova document.

For smooth workflows, the Advised Processing tool will be shown, the most sensible processing options for most 1D and 2D NMR spectra.

 

A chemist’s trusty paper laboratory notebook works for the individual, but fails at the team or group level. Mbook allows for shared projects that allow colleagues to collate their work for easier correlation of trends and interpretation of results.  Mbook can store and visualize spectroscopic results, such as NMR or LC/MS, in native format, where others force a downgrade to PDF.  Stockroom and inventory facilities are built-in, and everything is hosted on the web.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

ABOUT THE SPEAKERS

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Dr. Donna Baldisseri

Senior Applications Scientist
(Bruker BioSpin Corporation)

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Dr. Mike Bersntein

Vice President of R&D
(Mestrelab Research)

[/vc_column_text][/vc_column_inner][vc_column_inner width=”3/4″][vc_column_text]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.

 

 

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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.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row el_class=”hidden”][vc_column][vc_empty_space height=”64px”][ult_buttons btn_title=”REGISTER HERE!” btn_link=”url:%20https%3A%2F%2Fattendee.gotowebinar.com%2Fregister%2F897421792236091651||target:%20_blank|” btn_align=”ubtn-center” btn_size=”ubtn-block” btn_title_color=”#ffffff” btn_bg_color=”#b20e10″ icon=”none” icon_size=”24″ icon_color=”#ffffff” btn_icon_pos=”ubtn-sep-icon-at-left” btn_font_size=”desktop:20px;” btn_font_style=”font-weight:bold;”][/vc_column][/vc_row]

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