Sharing Science Solutions

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Day 1 – Welcome and Keynote Session I

Sep 21, 2021 7:00am ‐ Sep 21, 2021 8:15am

Session Speaker(s):

Jason Rouse, Pfizer, Inc.
Albert Heck, Utrecht University

Technical Seminar - Comprehensive Characterization of Etanercept Using Zenotof 7600 System

Sep 21, 2021 8:15am ‐ Sep 21, 2021 8:45am

Sponsored by SCIEX

Etanercept is a recombinant Fc fusion protein therapeutic, targeting inflammation regulation. It binds to the receptors TNFR and p75 to block adverse inflammation at the cellular level and has a complex distribution of post-translation modifications (PTM), such as N and O-linked glycans. Current CID-based MS/MS can struggle to characterize such PTMs, since side-chain species are typically fragmented via a mechanism that does not produce diagnostic ions related to the PTM localization. Other forms of fragmentation, such as ETD, can maintain side chain information but suffer from low sensitivity and scan rate, as well as inadequate coverage of low charge state peptides. In this study, a new form of fragmentation (electron activated dissociation, or EAD) was employed to comprehensively characterize the glycosylation of etanercept at the peptide level. A comparative analysis between intact/subunit and peptide mapping results was performed as a validation step for the novel EAD workflow. A total of 149Three N linked glycosylations were detected, as well as nine sites of O-linked glycosylation, with high confidences, via a single, generic, data-dependent LC-MS/MS analysis. Even in challenging cases, exact positioning information of the glycosylation on the peptide could be obtained. In addition, EAD allows for confirmation of amino acid isomers (Leu/IsoLeu and Asp/IsoAsp) via MS/MS analysis, in the same experiment, which will be presented as well.

Moderator(s):

Kerstin Pohl, SCIEX

Session Speaker(s):

Xuezhi Bi, Bioprocessing Technology Institute, A*STAR Research Entities

Session I - Molecular Design, Developability and Biotransformation

Sep 21, 2021 8:55am ‐ Sep 21, 2021 10:30am

Session Chair(s):

Christopher Chumsae, Bristol-Myers Squibb Company
Jonathan (JJ) Josephs, Genentech, a Member of the Roche Group

Session Speaker(s):

Randal Ketchem, Just - Evotec Biologics
John Tran, Genentech, a Member of the Roche Group
Xibei Dang, Merck & Co., Inc.

Session II - Product and Process Characterization

Sep 21, 2021 11:05am ‐ Sep 21, 2021 12:40pm

Session Chair(s):

Christopher Chumsae, Bristol-Myers Squibb Company
Ingo Lindner, Roche Diagnostics GmbH

Session Speaker(s):

Chun Shao, Bristol-Myers Squibb Company
Jill Bradley- Graham, Sanofi
Ravikiran Yerabolu, Moderna, Inc.

Day 2 – Welcome and Keynote Session II

Sep 22, 2021 7:00am ‐ Sep 22, 2021 8:05am

Session Speaker(s):

Da Ren, Amgen Inc.
Rohin Mhatre, Biogen

Technical Seminar - Large Molecules Get SLIM: Fast and Informative Large Molecule Characterization with High-Resolution Ion Mobility

Sep 22, 2021 8:05am ‐ Sep 22, 2021 8:35am

Sponsored by MOBILion Systems

How can High-Resolution Ion Mobility Mass Spectrometry (HRIM-MS) address the challenges of large molecule characterization? This seminar will discuss the benefits of HRIM-MS in enhancing structural characterization of large molecule therapeutics, while increasing throughput and reducing reliance on LC-based methods. Specific focus will be on how HRIM-MS provides more complete information on coeluting structural isomers, as well as and on emerging workflows.