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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 Attendees will then hear a diverse range of case studies and unpublished data discussing these relevant and useful analytical technologies for characterization.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.

Chairperson's Remarks:

Zhenyu Gu, Ph.D., Scientist III, Global Analytical and Pharmaceutical Development, Alexion Pharmaceuticals

Using QC Friendly Mass Spectrometry to Quantitate the Critical Charge Variant from a Minor Component in CombinationMingyan 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 TherapeuticsLuke 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 VectorsMarta Germano, Ph.D., Associate Scientific Director, Analytical Development, Janssen Vaccines

Analytical Technologies for Formulation Development and Characterization of Proteins and MoleculesTudor 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, Ph.D. - Associate Scientific Director, Analytical Development, Janssen Vaccines
  • Tudor Arvinte, Ph.D. - Chairman, CEO, Therapoemic Inc., University of Geneva, Switzerland
  • Zhenyu Gu, Ph.D. - Scientist III, Global Analytical and Pharmaceutical Development, Alexion Pharmaceutical

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

An Introduction to Bioassay Development

Building a Better Bioassay: An Introduction to Bioassay Development

Building a Better Bioassay: An Introduction to Bioassay Development

Workshop Overview

Development of cell-based assays (bioassays), a subtype of relative potency assays, is challenging to accomplish. These assays are often (incorrectly) associated with long run times, limited space on assay plates, minimal control and high %CV. However, when bioassays are developed and optimized correctly, they can actually be quite accurate, precise and robust in their performance. This bioassay development workshop will begin with an overview of the basic tools required for success: analyst training, critical reagent maintenance, laboratory/equipment set-up, assay formats, cell maintenance, propagation and banking, as well as regulatory expectations for Phase I/I/III clinical trials. Practical approaches to understanding the underpinnings of all aspects of bioassays, including design of assay formats, system suitability, and preparation for bioassay transfer, will be discussed. Approaches to working with a contract development and manufacturing organization will be discussed as well.

Workshop Outline

  • Introductions & Schedule
  • Why a Bioassay & Characterizing a ‘well characterized’ product
  • Basic tools: Analyst training, documents, equipment, reagents, assay formats, cells
  • Designing Bioassays Part I
  • Cells
  • Designing Bioassays Part II
  • Regulatory Expectations
  • Data Analysis/System Suitability and Acceptance Criteria
  • Data Trending
  • Supporting assay technologies
  • Bioassay Transfer
  • A global approach to bioassays: Outsourcing
  • Case Studies
  • Lessons Learned
  • Questions & Discussion

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
  • Workshop Moderator Michael Sadick, Ph.D. - Principal Scientist, Catalent Pharma Solutions
  • Workshop Moderator Michael Merges - Director of Strategic Growth, Biologics Analytical Services, Catalent Pharma Solutions