2013 Archived Content

Analytical Stream

3rd Annual
Characterization of Biotherapeutics

Effective Analytical Strategies for the Development of Complex Biotherapeutics

April 29-30

The application of analytical characterization in biopharmaceutical development has never been more important, with increasingly complex products, resource and time constraints and demanding regulatory requirements creating new demands on the analytical function. Industry companies must leverage legacy and emerging analytical methods for fast, accurate results that support development timelines and product goals, balancing the use of internal capabilities with those of contract organizations and collaborators.

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7:00 am Conference Registration and Morning Coffee

Characterization for Early Biotherapeutic Development 

8:30 Chairperson’s Opening Remarks

Lawrence Gan, Ph.D., Senior Director, Drug Metabolism & Pharmacokinetics, Biogen Idec

8:40 Pharmacokinetic and Disposition Profiling of  Biotherapeutics in Drug Discovery

Lawrence Gan, Ph.D., Senior Director, Drug Metabolism & Pharmacokinetics, Biogen Idec

To ensure effective pharmacotherapy of biotherapeutics (e.g. peptides, proteins, monoclonal antibodies, etc.), factors that impact the pharmacokinetics of these biologics need to be fully evaluated. Good understanding of the ADME processes of biotherapeutics, including target mediated disposition and immunogenicity, in the early drug discovery stage is essential in support of the development of therapeutic biologics. Examples of assessing CNS penetration (i.e. brain uptake) of mAb via CSF kinetics, radiolabeled biodistribution of mAb (imaging study) and tumor uptake, as well as PK/PD correlation between mAb and its pharmacologic activity will be discussed.  

9:10 Discovering Protein-Ligand Interactions on a Proteomic Scale

Chiwook Park, Ph.D., Associate Professor, Medicinal Chemistry and Molecular Pharmacology, Purdue University

To overcome issues of conventional affinity-based approaches, we developed energetics-based target identification in which protein-ligand interactions are identified from the changes in the conformational stabilities of proteins. We identified ATP-binding proteins in the E. coli proteome. Beyond known ATP-binding proteins, we also identified proteins that were not previously known to interact with ATP. 

9:40 Early Stage Biophysical Screening Strategies to Identify  Quality Biotherapeutic Candidates

Simon LowSimon Low, Ph.D., Senior Scientist, Protein Analytics, Adnexus, A BMS Company

Early stage biotherapeutic lead discovery typically relies on functional assays to characterize large panels of hits, often with limited biophysical assessment. This can lead to biophysical liabilities creating downstream CMC challenges. Using Adnectins as a model, we present a series of biophysical assays implemented in early discovery process to identify molecules with desirable biophysical properties for downstream development.

10:10 Grand Opening Coffee Break in Exhibit Hall with Poster Viewing

11:10 Effect of Post-Translational Modifications on Antibody  Functions

T. Shantha RajuT. Shantha Raju, Ph.D., Scientific  Director, Discovery Technology Research, Janssen Research & Development, LLC

Post-translational modifications may affect protein functions such as activity, stability and PK. Immunoglobulins are serum glycoproteins containing complex post-translational modifications. Such modifications create heterogeneous populations that may affect Ig functions and stability. This presentation discusses the heterogeneity of post-translational modifications and their effect on Ig’s functions.


11:40 Characterization of Monoclonal Antibodies Binding Interactions

Maria Leonor AlvarengaMaria Leonor Alvarenga, Ph.D., Scientific Co-Worker, Merck Serono, Germany

Success of novel mAb therapy depends on understanding mechanisms of interaction between antibodies and their cell targets. In vivo or cell studies should be complemented by characterization of interactions at the molecular level. Biophysical methods were used to characterize the interactions of cetuximab, panitumumab and matuzumab with the extracellular soluble form of the epidermal growth factor receptor. 


GE Healthcare Logo12:10 pm Monitoring Higher Order Structures in Biotherapeutic Development Using SPR, DSC and 2-D DIGE 

Alexander Kele, Ph.D., Global Marketing Manager, GE Healthcare Life Sciences 



Retrogenix12:40 Luncheon Presentation I: Discovery of High Quality Antibody Targets Using a Function-Led Approach: Solving the Target Deconvolution Bottleneck 

Jim Freeth, Ph.D., Managing Director, Retrogenix, Ltd 

Selecting antibodies through a desired functional effect, rather than against a pre-determined target, leads to the discovery of novel, disease-relevant antibody targets.  By expressing 3500 human plasma membrane proteins individually in human cells, Retrogenix’s Cell Microarray technology overcomes the target deconvolution hurdle, giving higher success rates than any other conventional approach.

1:10 Luncheon Presentation II: (Sponsorship Opportunity Available) or Lunch on Your Own 

Late Stage Development  and Manufacturing 

2:00 Chairperson’s Remarks

T. Shantha Raju, Janssen Research & Development, LLC

2:05 An Image is Worth a Thousand Words

Ivan Correia, Ph.D., Principal Research Scientist, Protein Analytics, Global Pharmaceutical Organization, Abbott Bioresearch Center

A dual specific, tetravalent immunoglobulin G (IgG) like molecule termed dual variable domain immunoglobulin (DVD-IgG) has been engineered to block two targets. Using single particle electron microscopy we describe the architecture and measure dynamics of this new class of molecules. Using 2D class average and 3D RCT analysis we provide the first detailed structural study of an intact bispecific molecule.

2:35 Quantitative Evaluation of Fucose Reducing Effects in a  Humanized Antibody on Fc γ Receptor Binding and Antibody-Dependent Cell-Mediated Cytotoxicity Activities

Shan ChungShan Chung, Ph.D., Senior Scientist, Bioanalytical Technologies & Strategies, Genentech

The effect of fucose reduction on Fc effector functions was quantitatively evaluated using an afucosylated anti-CD20 antibody, its “regular” fucosylated counterpart, and a series of mixtures containing varying proportions of “regular” and afucosylated materials.  Compared to the “regular” fucosylated antibody, the afucosylated antibody showed comparable CDC activity but markedly increased ADCC activity. 

3:05 Identification and Quantification of Host Cell Protein  Impurities in Biotherapeutics Using Mass Spectrometry

Andrew M. Goetze, Ph.D., Scientific Director, Product Attribute Science, Amgen

It is now technically feasible to identify and individually quantify host cell protein impurities in biotherapeutics using LC-MS. This approach offers significant advantages with respect to safety risk assessment and process development versus the traditionally employed immunoassays, but with the cost of increased methodological complexity. The pros and cons of this approach are illustrated using examples.

3:35 Characterizing Higher Order Structure of Biologics by Hydrogen/Deuterium Exchange Mass Spectrometry: From Comparability Studies to Epitope Mapping Analysis

Hui Wei, Ph.D., Senior Research Investigator, PCO BDAS Mass Spectrometry, Bristol-Myers Squibb Co.

Hydrogen/deuterium exchange mass spectrometry (HDX MS) probes protein conformation and conformational dynamics in solution by monitoring the rate and extent of deuterium exchange of protein backbone amide hydrogen. As a sensitive analytical tool, MS can precisely measure the mass increases of the protein upon HDX. A global view of protein conformation can be obtained by measuring the molecular weight of a protein and following its rate of deuterium incorporation as a function of incubation time in deuterated buffer. Pairing with enzymatic digestion, structural features at the peptide level can be resolved. In this presentation, applications of HDX MS in comparability studies at both global and peptide levels will be described for protein drug development. In addition, applications of HDX-MS in epitope mapping will also be presented for drug discovery. 

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 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.

Developing a Biophysical (Higher Order Structure, HOS) CMC Package for Protein Drug Regulatory Filings

Steven A. Berkowitz, Ph.D., Principal Scientist, Analytical Development, Biogen Idec, Inc.

  • What is the impact of internal vs external comparability on the biophysical components of a CMC BLA filing?
  • How can we justify investments in specialized and advanced biophysical characterization tools?
  • The role of industry and government/academia in developing better biophysical tools

Cell-Based vs. Non Cell-Based Methods: Where is the Good Balance?

Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen Inc.

  • What assay technologies offer advantages to address bioanalytical or drug development questions?
  • What does "functional assay" really mean?

Post-Translational Modification Considerations for Biosimilars

T. Shantha Raju, Ph.D., Scientific Director, Discovery Technology Research, Janssen Research & Development, LLC

  • Cell lines and culture conditions
  • Purification and characterization
  • Formulations and formulants
  • Storage and stability testing

5:45 - 6:45 Welcoming Reception in the Exhibit Hallwith Poster Viewing

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