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9:00am 5:00pm (480 mins)

Mass Spectrometry and Other Analytical Technology to Enable Protein and Molecule Characterization

Mass Spectrometry and Other Analytical Technologies to Enable Protein and Molecule Characterization

This multi-speaker workshop will begin with an introduction to an array of analytical technologies currently used. Attendees will then hear a diverse range of case studies and unpublished data discussing these relevant and useful analytical technologies for characterization.

Who should attend?

Anyone interested in analytical technology for characterization of proteins and molecules; including scientists currently using or wanting to learn more about NMR, various types of Mass Spectrometry and those involved in analytical R&D, CMC, Protein Analytical Chemistry, and mAb characterization.

Confirmed Workshop Presentations and Speakers:

  • Using QC Friendly Mass Spectrometry to Quantitate the Critical Charge Variant from a Minor Component in Combination
    Mingyan Cao, Ph.D., Senior Scientist II, Analytical Biochemistry, MedImmune

    Characterization and monitoring of the critical variant from mAb-B when it’s a minor component in combo are very challenging for conventional methods, but tackling these to create biological combination therapies can provide many benefits like reduction in medication errors and convenience to patients. This session features a case study of quantitating a critical charge variant (a CQA) in combination antibodies using QC friendly Mass Spec based analytics. This method was developed and utilized to measure specific CQA of the minor component in the co-formulated biological combination mixtures. You will hear about the systematic characterization, method development and qualification, and the challenges encountered during development of these new analytics.

  • Applications of 2D NMR for Characterization of Monoclonal Antibody Therapeutics
    Luke Arbogast, Ph.D., Research Chemist, National Institute of Standards and Technology

    High resolution two-dimensional (2D) heteronuclear 1H-15N-amide and 1H-13C-methyl NMR presents an excellent choice for characterization of monoclonal antibody higher order structure (HOS) at atomic resolution, since even small changes in chemical environment and structure give rise to readily observable changes in corresponding spectra. Indeed, we have previously demonstrated the feasibility of acquiring such spectra on both intact mAbs as well as protease cleaved constituent Fab and Fc domains at natural isotopic abundance. We will present on the continued development and validation of 2D NMR methods for characterization of therapeutic mAbs, including results detailing optimal performance in terms of precision and sensitivity using both conventional and non-uniform sampling methods.  We will further demonstrate how systematic collections of such spectra can be statistically analyzed via multivariate approaches such as Principal Component Analysis (PCA) to correlate spectra according specific attributes of analyte HOS using a series of enzymatically remodeled glycoforms of the NISTmAb Reference Material.  Finally, we detail the precision and robustness with which these methods can be applied in the biopharmaceutical setting.

  • Mass Spec for Potency Testing of Adenovirus Vectors
    Marta Germano, M.S., Associate Scientific Director, Analytical Development, Janssen Infectious Diseases and Vaccines

  • Analytical Technologies for Formulation Development and Characterization of Proteins and Molecules
    Tudor Arvinte, Ph.D., Titular Professor of Biopharmaceutics, University of Geneva - Switzerland & Chairman, CEO, Therapeomic Inc.

More sessions to be announced soon!

  • Mingyan Cao, Ph.D. - Senior Scientist II, Analytical Biochemistry, MedImmune
  • Luke Arbogast, Ph.D. - Research Chemist, National Institute of Standards and Technology (NIST)
  • Marta Germano, M.S. - Associate Scientific Director, Analytical Development, Janssen Infectious Diseases and Vaccines
  • Tudor Arvinte, Ph.D. - Chairman, CEO, Therapoemic Inc., University of Geneva, Switzerland

9:00am 5:00pm (480 mins)

An Introduction to Bioassay Development

An Introduction to Bioassay Development

Workshop Overview

This workshop will provide an introduction to CMC bioassay development and the role of biological assays in the CMC process and product characterization lifecycle. You will learn about strategies for the design, development and validation of biological assays for a variety of different molecules, including some of the complex, non-platform modalities emerging. You will learn about the role of automation, new technologies and statistics in the bioassay development and validation process, as well about challenges and pitfalls to avoid. The regulatory bar for CMC biological assay development is moving ever-higher and you will also learn about the latest regulatory expectations for CMC bioassay development and steps you can take to ensure your biological assay will meet these higher standards. Case studies will illustrate lessons learned from a variety of CMC bioassay programs that you can use to improve your own bioassay development and validation efforts.

Who should attend?

Scientists, Managers and Directors in:

  • CMC Bioassay Development, Assay Innovation
  • Analytical R&D
  • CMC
  • Protein Analytical Chemistry 
  • Product Characterization 
  • Statistics
  • Biological Development and Biological Technologies
  • Bioanalytics
  • Regulatory Affairs, QA/QC