2013 Archived Content
 

Analytical Stream

Inaugural
Biophysical Analysis of Biotherapeutics

Characterizing the Physical Properties of Proteins in Biotherapeutic Research and Development

May 1-2, 2013

Biophysical analytical methods play a useful role in an overall analytical strategy, augmenting biochemical and biological methods used for research, process and product development of macromolecules.  These techniques are critical for understanding the structure and behavior of proteins under different stress conditions, and they are essential tools for understanding binding behavior and conducting characterization studies for regulatory filings and product development. 

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 Tuesday, April 30 from 4:15 - 5:30 PLENARY KEYNOTE PANEL 

Conventional vs. Non-Conventional Formats 

 Janice ReichertModerator: Janice Reichert, Ph.D., Editor-in-Chief, mAbs; Managing Director, Reichert Biotechnology Consulting LLC
With the explosion in the number of formats available, what are the potential benefits and risks to patients? This panel will discuss the realistic outlook and uncertainties with developing a diverse array of non-canonical antibodies in terms of immunogenicity, safety, competitive marketplace, commercial development, business strategies, regulatory approval, target validation and clinical development.
 

Panelists: 

David Meininger David Meininger, Ph.D., MBA, Executive Director, Molecular Discovery, Merck



 

Tillman GerngrossTillman Gerngross, Ph.D., CEO and Co-Founder, Adimab LLC; Professor, Bioengineering, Thayer School of Engineering, Dartmouth College


 

Trudi VeldmanTrudi Veldman, Ph.D., Senior Director, Biologics Generation, AbbVie



 


WEDNESDAY, MAY 1

7:00 am Conference Registration and Morning Coffee


Biophysical Characterization in Early Development 

8:30 Chairperson’s Opening Remarks

Peter M. Tessier, Ph.D., Assistant Professor of Chemical and Biological Engineering, Center for Biotechnology & Interdisciplinary Studies, Rensselaer Polytechnic Institute

8:40 High-Throughput Analysis of Monoclonal Antibody Self-Association in Complex Mixtures for Improved Antibody Selection and Formulation

Peter TessierPeter M. Tessier, Ph.D., Assistant Professor of Chemical and Biological Engineering, Center  for Biotechnology & Interdisciplinary Studies, Rensselaer Polytechnic Institute

A challenge in developing therapeutic antibodies is their propensities to self-associate at high antibody concentrations required for subcutaneous delivery. We will discuss a new method capable of identifying mAbs with low self-association propensity that is robust even for dilute mAb solutions and in presence of cell culture media. This general approach makes it well suited for use in diverse settings.

 

9:10 Application of a High-Throughput Solubility Assay for Selecting De-Risked Protein Therapeutic Candidates in Discovery

Aaron YamniukAaron Yamniuk, Ph.D., Senior Research Investigator, Research and Development, Bristol-Myers Squibb

Aggregation propensity is a critical attribute of protein therapeutics that influences the ease with which they can be discovered, purified and formulated. This presentation will discuss the application of a novel high throughput solubility assay for selecting protein therapeutic candidates with low aggregation propensity and high “developability” to progress into development.

9:40 Analytical Characterization of Biotherapeutics in Early Phase Clinical Development: Application of Biophysical Methods

Gopalan SomanGopalan Soman, Ph.D., Development Manager III, Biopharmaceutical Development Program, SAIC-Frederick, Inc., National Laboratory for Cancer Research

The presentation focuses on application of biophysical methods such as DLS/SLS, SPR, MS, CD, DSC, etc., in the early phase product development efforts of biotherapeutics.  Specific cases where the biophysical methods provided valuable information that lead to successful process and formulation development as well as product comparability assessment will be presented.

10:10 Coffee Break in the Exhibit Hall with Poster Viewing


Biophysical Evaluation of Proteins at High Concentration 

11:10 Mind the Gap: Light Scattering Analysis of Biotherapeutics in High and Low Concentration

Michael MarlowMichael Marlow, Ph.D., Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

Biomolecular phase behavior and self-interaction are concentration dependent. Formulated biotherapeutics often exceed the high concentration threshold and the resulting non-ideality complicates estimation of critical attributes from measurements under dilute conditions. LS techniques are applicable in dilute or high concentration regimes. Approaches to bridge the dilute-high concentration gap are discussed.

11:40 Application of Higher Order Structural Characterization Techniques to Understand the Functional Relationship of a Monoclonal Antibody and its Target Ligand

Kelly ArthurKelly K. Arthur, Senior Associate Scientist, Analytical Sciences, Amgen, Inc.

We used biophysical techniques to study in vitro binding of a monoclonal antibody to its target ligand. The association of native antibody to ligand was investigated using multiple biophysical analytical methods. These techniques were applied to study a forcibly oxidized antibody sample with known modifications to its primary structure and reduced in vitro potency compared to the native antibody. 

Wyatt12:10 pm Screening and Characterizing Biomolecular Interactions by Static and Dynamic Light ScatteringJohn Champagne, Ph.D., Senior Applications Scientist, Wyatt Technology Corp.
Daniel Some, Ph.D., Principal Scientist, Wyatt Technology Corp.
Static and dynamic light scattering are versatile techniques for the quantitative analysis of biomolecular interactions such as reversible self-association, drug-target binding, and aggregation. This talk will span topics from high-throughput screening of formulations for colloidal stability to in-depth analysis of the affinity and absolute stoichiometry of protein-protein complexes, all by means of solution-based light scattering.

12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

1:40 Session Break


Biophysical Tools to Identify and Solve Stability Problems in Biopharmaceutical Development 

2:00 Chairperson’s Remarks

JJ Phillips, Ph.D., Postdoctoral Fellow, Antibody Discovery and Protein Engineering, MedImmune, United Kingdom

2:05 Qualification of Differential Scanning Calorimetry for Thermal Stability Analysis of Proteins

Jie WenJie Wen, Ph.D., Senior Scientist, Product Attribute Sciences, Amgen, Inc.

Regulatory agencies are increasingly asking for qualification of biophysical characterization methods. We identified parameters for the qualification of DSC for thermal stability analysis of proteins. Experiments and data analyses were performed using different instruments at different sites. Results show that DSC is an appropriate method for assessing thermal stability and conformational changes.

2:35 Engineering Stability into Therapeutic Antibodies - Structure and Dynamics Studies of Chemical and Physical Degradation

JJ PhillipsJJ Phillips, Ph.D., Postdoctoral Fellow, Antibody Discovery and Protein Engineering, MedImmune, United Kingdom

HDX mass spectrometry was coupled with soft-fragmentation techniques to study antibody structure and dynamics. This is interpreted together with computational modeling and simulation to build a detailed picture of the dynamic protein molecules in the chosen aqueous matrix. This combination of technologies will enable screening of proteins with the desirable physicochemical behavior at an early stage.

Bio-Rad3:05 Antibody Characterization Using Multiplexed SPR 

Hassan Issafras, Ph.D., XOMA Corp. 

Surface plasmon resonance (SPR) is a powerful technology for characterizing therapeutic antibody mechanism of action and mechanistic screening of antibodies. Analysis of multiple interactions in parallel using multiplexed SPR offers several advantages over conventional SPR including increased throughput and ability to conduct side-by-side comparisons of binding kinetics under different conditions.

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

4:20 Problem Solving Breakout Discussions

Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.

Artifacts in Biophysical Characterization Assays and How to Control or Avoid Them

Michael Marlow, Ph.D., Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

  • How do we know the results obtained after sample preparation and analysis are fully representative of the true drug substance or drug product?
  • Assessing product quality attributes of monoclonal antibodies

Label Free Biophysical Methods & Functional Activity Assays

Gopalan Soman, Ph.D., Development Manager III, Biopharmaceutical Development Program, SAIC-Frederick, Inc., National Laboratory for Cancer Research

  • Surface Plasmon Resonance- Biacore Binding Assays
  • Label Free Cell Based Assays

Protein Aggregation

Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Department of Industrial and Physical Pharmacy, Purdue University

  • What are the key analytical challenges in characterizing protein aggregates?
  • How do aggregate size, morphology and surface chemistry determine immunogenicity? What do we know, and what do we still need to learn?
  • How can protein aggregation be prevented, or at least inhibited?
 

Blue Sky Bioservices5:20 Networking Reception in the Exhibit Hall with Poster Viewing


6:15 Poster Award

6:30 End of Day



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