Biopharmaceutical Analysis Focus 2020: A Virtual Symposium

Register Free: ​ https://www.chromatographyonline.com/lcgc_s/bio_analysis_focus_2020​

Event Overview: Biopharmaceutical analysis is a fast-paced and constantly evolving field, and chromatographers play a pivotal role. This two-day virtual event, focusing on cutting-edge trends, has been organized by The Chromatographic Society (“ChromSoc”) in collaboration with LCGC and features talks from top analytical chemists working in biopharmaceutical analysis. Join us to learn about the latest techniques and practical approaches from key practitioners in the field. Ask the experts your questions when they all come together for a live question-and-answer (Q&A) session on day two. The event will also include a short presentation about how joining ChromSoc can help to enhance your knowledge and skills in separation science.

Key Learning Objectives:

• Learn about the latest cutting-edge trends in biopharmaceutical analysis from leading professionals in this exciting area of life science research
• Discover the latest analytical technologies for N-glycan analysis of monoclonal antibodies
• New trends in size and charge variant analysis
• Ion pairing methods for oligonucleotide analysis
• In-depth characterization techniques for monoclonal antibodies and antibody–drug conjugates by 1D-, 2D- and 4D-LC–MS–based peptide mapping
• The array of benefits for joining the Chromatographic Society (ChromSoc)
• Ask the experts questions on their presentations in a live Q&A session.

Day 1 Speakers:

Sara Carillo, Applications Development Team Leader, Characterisation and Comparability, Laboratory, National Institute for Bioprocessing Research & Training (NIBRT), Ireland

Davy Guillarme, Senior Lecturer and Research Associate, The University of Geneva, Switzerland

Robert MacNeill, Head of Method Development, Department of Bioanalysis, Covance, Somerset, New Jersey, USA

Tony Edge, President, Chromatographic Society

Day 2 Speakers:

Alexandre Ambrogelly, Gilead Sciences

Tony Edge, ChromSoc, GMT

Koen Sandra, Scientific Director and Co-owner, the Research Institute for Chromatography (RIC)

Day 2 Q&A Speakers:

Alexandre Ambrogelly

Sara Carillo

Davy Guillarme

Robert MacNeill

Tony Edge,

Koen Sandra

Times and Dates:

Day 1, Wednesday, November 18, 2020

9am–11:30am EST | 2pm – 3:30pm GMT | 3pm-4:30pm CET

9am EST - Analytical Technologies for the N-glycan Analysis of Monoclonal Antibodies

Sara Carillo, National Institute for Bioprocessing Research and Training (NIBRT), Ireland

In monoclonal antibodies, many functions are regulated by N-glycans present in the constant region of the heavy chains. The importance of their function focuses efforts of analytical research on the development of robust, accurate, and fast methods to support drug development and quality control. Analysis of fluorescently labelled released N-glycans is considered the gold standard for glycosylation characterisation; however, it is not the only method for quantitative analysis of glycoform heterogeneity. In this study presented here, 10 different analytical workflows for N-glycan analysis were compared on four therapeutic monoclonal antibodies and evaluated for robustness and accuracy of the results and need for analyst expertise.

9:45am EST - New Trends in Size and Charge Variants Analysis

Davy Guillarme, University of Geneva, Switzerland

The characterization of therapeutic monoclonal antibodies (mAbs) and related compounds, such as fusion proteins, antibody–drug conjugates (ADCs), and bispecific antibodies (BsAbs), is a tremendous challenge to state-of-the-art analytical technologies. Indeed, subtle changes in these large (>150 kDa) molecules can have profound effects on efficacy and safety. It is therefore important to have the ability to rapidly and accurately assess changes in the distribution of different isoforms—such as oxidation, deamidation, and lysine truncation—of thesebiomolecules. This talk will discuss the latest developments in this pivotal area of biopharmaceutical analysis and provide practical insights.

10:30am EST - Shaking Off the Oligonucleotide Ion-pair: Initial Work in the BMV Context

Robert MacNeill, Covance, New Jersey, USA

In this talk, work is presented on oligonucleotide bioanalysis using liquid chromatography–mass spectrometry (LC–MS). Oligonucleotide therapeutics are big news in current times and an important component of our work. For several reasons, our laboratory prefers not to dedicate any LC–MS systems to ion-pairing methodologies; instead, we attempt to circumvent the traditional ion-pairing approach for oligonucleotide applications and use the alternative, and inherently more suitable chromatographic mode of hydrophilic interaction liquid chromatography (HILIC), to produce equally or more rugged methods that may be validated. Details of the initial application and other interesting aspects will be discussed.

11:15am EST - Join ChromSoc: Join the Separation Science Community

Tony Edge, ChromSoc, GMT

Learn about the Chromatographic Society and how to become part of the separations community that will help you to develop your career in separation science and enhance your skill.

11:30am EST - End of Day 1's Sessions

Day 2, Thursday, November 19, 2020

9am–11:30am EST | 2pm – 3:30pm GMT | 3pm-4:30pm CET

9am EST - Regulatory Considerations for the Development of Biomolecule Therapies

Alexandre Ambrogelly, Gilead Sciences

9:25am EST - Join ChromSoc: Join the Separation Science Community

Tony Edge, ChromSoc, GMT

Learn about the Chromatographic Society and how to become part of the separations community that will help you to develop your career in separation science and enhance your skill.

9:35am EST - In-depth Characterization of Monoclonal Antibodies and Antibody-drug Conjugates by 1D-, 2D- and 4D-LC-MS- based Peptide Mapping

Koen Sandra, Research Institute for Chromatography (RIC)

Biopharmaceuticals such as monoclonal antibodies (mAbs) and antibody–drug conjugates (ADCs) have reshaped the pharmaceutical industry in the past two decades and are today amongst the most lucrative and fastest growing class of therapeutics. Their success is driven by their efficacy in disease areas with a high unmet medical need such as oncology and autoimmune and infectious diseases. This contribution reports on state-of-the-art peptide map analysis of mAbs and ADCs using liquid chromatography–mass spectrometry (LC–MS). One-dimensional (1D) separations using micropillar array columns, comprehensive two-dimensional (2D) LC–MS using reversed-phase LC operated at pH extremes in both dimensions, and four-dimensional (4D) LC–MS implementing online reduction, digestion, and LC–MS analysis of charge variants resolved by cation exchange chromatography (CEX) will be touched upon.

10:15am EST - Question-and-Answer (Q&A) Session

All the experts from the two-day symposium—Sara Carillo, Davy Guillarme, Robert MacNeill, Tony Edge, Dell Farnan, and Koen Sandra—come together to answer questions about their presentations and areas of expertise.

11:30am EST - Event Close

On demand available after final airing until Nov. 19, 2021

Sponsor: Advanced Materials Technology, Agilent, Avantor, MilliporeSigma - the life science business of Merck KGaA, Darmstadt, Germany - Tosoh Bioscience

Register free: ​ ​https://www.chromatographyonline.com/lcgc_s/bio_analysis_focus_2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

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