Analytical Characterization - Day 2

Analytical Characterization

This exciting new event covers advanced technologies for physicochemical and biological characterization for a range of complex therapeutic proteins to provide a fuller understanding of the product, to ensure safety and efficacy, and to facilitate smooth and efficient interaction with the regulatory authorities. It focuses on advances in mass spectrometry, post-translational modifications, bioassays, characterization of impurities, and regulatory perspectives. The emphasis is on case studies, practical application, technology transfer and on fulfilling regulatory expectations.

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Tuesday, April 5



8:25 am Chairperson’s Opening Remarks

Qin Zou, Ph.D., Senior Principal Scientist, Analytical Research & Development, Pfizer, Inc.

8:30 Emerging Mass Spectrometry Methods for Characterization of Conformation and Dynamics of Biopharmaceutical Products

Igor_KaltashovIgor Kaltashov, Ph.D., Associate Professor, Chemistry, University of Massachusetts and Shire Human Genetic Therapies

The paramount importance of conformation as a defining element of efficacy, stability and safety of therapeutic proteins places a premium on our ability to characterize higher order and dynamics. Mass spectrometry shows tremendous promise, offering a robust, reliable and sensitive way to assess conformational integrity of protein-based drugs. We will discuss several examples of how this technology can be used in the industry, highlighting both recent achievements and current challenges.

9:00 Extending the Use of Mass Spectrometry-Based Methods for Antibody Comparability Studies

Alain_BeckAlain Beck, Ph.D., Head, Physico-Chemistry, Centre d'Immunologie, Pierre Fabre

Emerging high-resolution Mass Spectrometry (MS) methods in combination with ultra-performance separation techniques enable the identification of minor components like charge variants, glycoforms, disulfide bridge isoforms and other low level molecular species, that may trigger difficulties for comparability studies. Case studies of the input of native MS to investigate Antibody-Antigen complexes, of Ion Mobility MS and of ETD will be presented and discussed.

9:30 Characterization of IEC Fractions of a Monoclonal Antibody

Marco_Thomann Marco Thomann, Ph.D., Group Leader, Development Analytics, Roche Diagnostics GmbH

Ion Exchange Chromatography, IEC, is a widely used analytical method during process development or for release of therapeutic proteins. A broad spectrum of analytical methods can be applied to gather information about the characteristics of each IEC peak. In this case study, the results of the characterization of IEC peaks of a therapeutic MAB bearing a hot spot region are presented. An emphasis is put on mass spectrometric analysis of PTMs.

10:00 Novel Approaches for Characterizing Oligosaccharides in a Monoclonal Antibody with Glycosylation Sites in the Fab and Fc Regions

M Brzezinski Monica Brzezinski, Ph.D., Senior Principal Scientist, Biotherapeutics, Analytical Research & Development, Pfizer, Inc.




10:30 Networking Coffee Break with Exhibit and Poster Viewing

11:00 Case Study: Analytical & Process Development of Recombinant Targeted Secretion Inhibitors (TSIs)

Aimee Cossins, Ph.D., Group Leader, Analytical & Formulation Development, Syntaxin Ltd.

Syntaxin have developed an innovative Targeted Secretion Inhibitor (TSI) technology platform to generate a new of protein biopharmaceutical for therapeutic treatment of neurological, endocrine and proliferative (oncology) secretion disorders. These novel recombinant proteins act through selective inhibition of cell secretory processes. This presentation will focus on the technical challenges in the analytical characterization and process development of TSIs produced by microbial cell culture.

11:30 Orthogonal Confirmation for Analytical Method Development: A Biophysical Perspective

Qin_ZouQin Zou, Ph.D., Senior Principal Scientist, Analytical Research & Development, Pfizer, Inc.

Analytical tests for batch release often need support from other characterization methods to ensure their accuracy. During method development, in-depth biophysical characterization methods help provide detailed information about molecular identification, size distribution, solution properties, etc. Case studies will be provided to illustrate the application of those characterization methods.

12:00 pm In-depth Characterization Studies of a Candidate Anti-CD20 Antibody to Assist the Determination of Its Critical Quality Attributes

Ying_HsiangYung-Hsiang Kao, Ph.D., Senior Scientist & Group Leader, Protein Analytical Chemistry, Genentech, Inc.



12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own 


1:55 Chairperson’s Remarks

Alain Beck, Ph.D., Head, Physico-Chemistry, Centre d'Immunologie, Pierre Fabre

2:00 Assessment of Glycation in mAb Drug Candidates

Daniel_HigaziDaniel Higazi, Ph.D., Scientist, Analytical Biochemistry, MedImmune Ltd.

Glycation is a non-enzymatic, post-translational condensation reaction that results in the covalent attachment of reducing sugars (typically glucose) to Lysine and/or N-terminal amine groups. Glycation can disrupt mAb structure, impairing the ability to bind antigen. This presentation will focus on strategies used to assess glycation as a potential critical quality attribute, in support of mAb product development. Case studies detailing the relationship between glycation, mAb structure and bioactivity will be presented.

2:30 – 3:30 Breakout Discussions

Join an interactive moderated discussion on topics of interest in the field of analytical characterization including:

  • Challenges with Potency Assays for Specifications and Release
  • Characterization Protocol for PTMs Throughout Development
  • Challenges with Determining Tertiary and Quaternary Structure
  • Managing Successful Technology Transfer
  • Linking PTMs with Safety & Efficacy
  • Incorporation of Bioassays, Potency Assays and Binding Assays into a Comparability Program

3:30 Networking Refreshment Break with Exhibit and Poster Viewing


4:00 Post-Translational Characterization to Support Formulation Decisions

John_O'HaraJohn O’Hara, Ph.D., Associate Director, Analytical Development, Biologicals, UCB-Celltech

Understanding the impact of pH, excipients and other factors on PTMs such as disulfide shuffling, deamidation, glycation, oxidation and mis-incorporation can help to support formulation decisions. Liquid formulations which present biologics in a highly concentrated form potentially experience increased levels of aggregation, solubility and viscosity. This presentation will provide case studies in which physicochemical and biophysical characterization techniques have been used to understand the impact of formulation on protein PTMs.

4:30 A Novel Approach on Characterization and Quantitation of Post Translational Modifications in Monoclonal Antibodies

Jette Wypych, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.

As the biopharmaceutical industry moves toward the concept of Quality by Design, the analytical paradigm is shifting. It may no longer be sufficient to control chromatographic and/or electrophoretic peak groups from traditional analytical methods typically used as a surrogate for controlling the production processes; rather, specific posttranslational modifications should be monitored to control both process performance and product quality with respect to defined critical quality attributes. This presentation will emphasize the advantages of a novel analytical strategy. Detailed examples will be discussed to demonstrate the practicality of the use of this novel strategy in the analysis of therapeutic monoclonal antibodies.

5:00 – 6:00 Networking Reception in the Exhibit Hall

6:00 End of Part One

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