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Mass Spec 2024

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  • Thumbnail for Session I: Molecular Design, Developability and Biotransformation
    Date
    September 11, 2024

    Session Chairs: Jason Rouse, Pfizer, Inc. and Christopher Yu, Genentech, a Member of the Roche Group


    Session Description:

    Mass spectrometry (MS) plays a pivotal role in the earliest stages of biotherapeutics development with respect to molecular design, developability and biotransformation. First, LC-MS characterization of multiple, early constructs in the ‘molecular design’ phase confirms that the intended molecule with the full-length sequence and expected posttranslational modifications was indeed expressed by the cell line and isolated by the purification process. For candidate molecules, ‘developability’ encompasses both predictive and experimental measures of physicochemical properties (including pharmacokinetics [PK]), which collectively enable selection of the optimal construct for more straightforward early- and late-stage product and process development, as well as clinical development (accounting for clinical indication, dosage, and administration route). As part of developability, stability studies combined with LC-MS/MS and biological activity measurements allow for early elucidation of structure-function relationships, in addition to the identification of potential sequence liabilities for subsequent engineering. Lastly, ‘biotransformation’, as monitored by LC-MS/MS, provides insight on how the molecular structure may change during in vivo circulation (after administration) to cause either a gain or loss of function (and/or altered circulating half-life). Biotransformation of therapeutic glycoproteins can involve protease fragmentation, glycosidase re-modelling, and increased deamidation, isomerization, oxidation, and glycation, in addition to removal of particular isoforms by certain receptors.


    Session Speakers:


    Intact Mass Characterization of Multi-Specific Therapeutic Antibodies

    Kalie Mix, Sanofi


    Antibody A In Vitro Biotransformation/Succinimide Characterization in Human Plasma by Immunoaffinity Purification (IA) – LC-MS and LC-MS/MS

    Mei Han, Merck & Co., Inc.


    Immunocapture Based LC/MS Investigation of Different Glycoform Clearance of a Biotherapeutic mAb in Human Serum 

    Jayanta Kishor Chakrabarty, Boehringer Ingelheim

  • Thumbnail for Session II: Mass Spectrometry in Cell & Gene Therapy
    Date
    September 11, 2024

    Session Chairs: : Rich Rogers, Umoja Biopharma and Chris Yu, Genentech, A Member of the Roche Group


    Mass spectrometry (MS) has emerged as a powerful analytical tool in the field of cell and gene therapy. As these therapies continue to revolutionize medicine, understanding their complex processes and ensuring consistent product quality become critical objectives. In this session, we explore how MS-based analytical technologies are advancing our understanding and the manufacturing of cell and gene therapy drug products.

    Session Speakers:


    A Novel In-Vitro Expression LC/MS/MS Assay for mRNA Vaccine Characterization

    Olga Friese, Pfizer, Inc.


    Characterising Viral Vectors for Gene Therapy using Mass Spectrometry on Different Levels

    Jonathan Bones, NIBRT


    Enabling Biopharmaceutical Applications of Electrostatic Linear Ion Trap Charge Detection Mass Spectrometry (ELIT-CDMS)

    Rebecca D’Esposito, Waters Corporation 

  • Thumbnail for Session III: Joint MS/HOS Plenary Session: Mass Spec Technologies in HOS / Comprehensive Toolboxes for Complex Problems
    Date
    September 11, 2024

    Session Chair: Frances Namuswe, CDER, FDA


    Have a case study where mass spectrometry was used along with biophysical techniques or vice versa? Consider submitting your abstract to the joint CASSS MS and HOS session! For presentations at this session, the CASSS HOS and MS organizing committees are looking for examples of complimentary applications of various MS and HOS techniques to characterize complex systems and elucidate all types of structures. Bring your story of how HOS techniques and MS can solve challenging problems together!



    Session Speakers: 


    Radical Protein Footprinting in Stabilized Whole Blood

    Joshua SharpUniversity of Mississippi


    Characterization and Mechanistic Insights into the Formation of a mAb Hetero-Clipped Dimer

    Joseph Valente, Bristol-Myers Squibb Company 


    Charge Detection Mass Spectrometry for Stoichometry and Assembly

    Martin Jarrold, Indiana University 

    Advancements in Subzero Temperature Chromatography for HDX-MS

    Kyle Anderson, National Institute of Standards and Technology (NIST)

  • Thumbnail for Diverse Voices: Breakfast Session
    Date
    September 12, 2024

    Diversity is not a color. It is who is represented in the workplace, research, and society. Examples include gender diversity, age diversity, ethnic diversity, physical ability and neurodiversity.

    Equity: Fair treatment for all people resulting in equality. The unique circumstances of each person is considered, treatment is adjusted accordingly to ensure the end result is equal.

    Inclusion: How the workforce experiences the workplace and to what degree organizations embrace all employees and enable them to make meaningful contributions. Inclusive cultures ensure that all voices are heard.


    Session Speakers:


    Penny Peterson, Tolmar, Inc.

    Cynthia Ziwawo, Indiana University

    Geoffrey Hutchinson, University of Washington

    Olubukola Abiona, NIH-Oxford

  • Thumbnail for Session IV: New Technologies, Approaches, and Methods
    Date
    September 12, 2024

    Session Chairs: Ingo Lindner, Roche Diagnostics GmbH and Hillary Schuessler, Merck & Co., Inc. 


    Session Speakers:


    Advanced MS-based Technologies to Tackle Characterization Challenges of Complex Formats and New Modality Biotherapeutics

    Feng Yang, Genentech, A Member of the Roche Group


    High-throughput Screening Strategies to Characterize Protein Conjugation

    Anumita Saha, Merck & Co., Inc.


    Use of Multi-Attribute Methods for In-Process Monitoring and Quality Control of Complex Biologics

    Anita Liu, Merck & Co., Inc.

  • Thumbnail for Lunch and Learn Technical Seminar presented by Agilent Technologies, Inc.
    Date
    September 12, 2024

    Session Speaker:


    Strategies for Expedited Characterization of Higher Order Structure: Microdroplet Reactions Coupled to Ion Mobility with Collision Induced Unfolding and Electron Capture Dissociation.

    Thomas Walker, Agilent Technologies, Inc.

  • Thumbnail for Session V: Multispecifics and ADCs Characterization
    Date
    September 12, 2024

    Session Chairs: Chris Chumsae, Bristol-Myers Squibb Company and Frances Namuswe, CDER, FDA


    Session Speakers:


    Glyco-Analysis of a Glycoengineered VHH-Radioligand Therapy Designed for Improved Biodistribution

    David Bush, Novartis 


    Characterization of ADCs in Serum and Formulation Buffer

    Tun Liu, Johnson & Johnson


    Development of Novel Chromatographic and Mass Spectrometric Techniques for Characterizations of BsAbs and ADCs

    Fengfei Ma, Merck & Co., Inc.  

  • Thumbnail for Session VI: Next Generation Investigator Awards
    Date
    September 12, 2024

    Session Chairs: Richard Rogers, Umoja Biopharma and Sarah Rogstad, CDER, FDA


    Session Description:

    The future of our field is heavily dependent on innovative science from new and upcoming researchers. The Next Generation Investigator (NGI) session will showcase the cutting edge work of three very talented early career scientists. We look forward to learning what these next generation investigators have been working on to advance applications mass spectrometry.


    Session Speakes:


    Proteoform Specific Microheterogeneity Assessment of Biopharmaceuticals Using a Modified Orbitrap Tribrid Mass Spectrometer

    Corentin Beaumal, NIBRT, National Institute for Bioprocessing Research


    Middle-down Approach Using Proton Transfer Charge Reduction Enables Unambiguous Drug-Payload Localization in Cys-linked Antibody Drug Conjugates

    Linda Lieu, University of Oklahoma 


    A Novel Mass Spectrometry-Based Footprinting Method for RNA Higher Order Structure

    Natashia Yang, Washington University in St. Louis 

  • Thumbnail for Session VII: MS Trends in Regulatory Research, Review, and Standard
    Date
    September 12, 2024

    Session Chairs: Sarah Rogstad, CDER, FDA, and Frances Namuswe, CDER, FDA




    Panelists:


    Jinhui Zhang, CDER, FDA 

    Trina Mouchahoir, NIST, 

    Michael Strader, CBER, FDA 

    Kevin Carrick, US Pharmacopeia

  • Thumbnail for Session VIII: MAM for Product & Process Characterization & Quality Control
    Date
    September 13, 2024

    Session Chairs: Ingo Lindner, Roche Diagnostics GmbH and Da Ren, BioTherapeutics Solutions


    Session Speakers: 


    USP Standards and Tools to Establish System Readiness and Facilitate Implementation of the Multi-Attribute Method

    Sheila Mugabe, US Pharmacopeia


    Development of LCMS MAM Methods for Protein and Oligonucleotide Therapies

    Serena Wu, Regeneron Pharmaceuticals, Inc. 


    Towards the Global Approval of MAM Testing Strategy

    Joseph Mulholland, Johnson & Johnson

  • Thumbnail for Session IX: Multi-Omics in Process Development
    Date
    September 13, 2024

    Session Chairs: Chris Chumsae, Bristol-Myers Squibb Company and Andrew Mahan, Johnson & Johnson Innovative Medicine 


    Session Speakers:

    Application of Multi-Omics Analysis to Enhance Upstream Bioprocessing Understanding

    Amr Ali, AbbVie


    Deep Proteomic Profiling of the CHO Cells Reveals Correlates of Runaway Lactate 

    Joshua Justice, Johnson & Johnson


    Targeted Metabolomic Analysis of mAb producing CHO cells: Impact of Bioprocess Conditions on CHO Cell Metabolism and Lactate Runaway

    Nandakumar Madayiputhiya, Bristol-Myers Squibb Company