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Advances in Label-free Assays for Quantitation and Kinetic Characterization of Biotherapeutics


Thursday, March 31, 2011
11:30am – 1:00pm EST

 

Label-free assays hold great promise for complementing or replacing label-based and other technologies currently in use in the drug discovery process. Real-time monitoring of biomolecular interactions in label-free format provides information on binding kinetics, affinity and sample concentration that benefits a large number of applications in bioprocessing, biotherapeutic discovery and development, as well as in quality control of drug candidates.

Panelists Include:

Ryan CaseRyan Case, Ph.D., Senior Scientist, Amgen, Inc.

 


Mark DysingerMark Dysinger, Senior Scientist, Pfizer Global Research and Development

 


Sriram KumaraswamySriram Kumaraswamy, Ph.D., Senior Product Manager, ForteBio, Inc.

 

 

James Delproposto Moderator: James Delproposto, Research Associate, University of Michigan

 

 

What Will Be Covered:

  • Label-free assay use in biotherapeutics discovery and development
  • Kinetic characterization of protein-protein interactions in purified and bacterial lysates
  • Off-rate screening of proteins in bacterial lysates
  • Development and qualification of label-free quantitation assays
  • Quantitation of humanized antibody therapeutic in comparison to ELISA
  • Benefits of converting existing ELISA assays to label-free assays
  • Label-free analysis of cell signaling pathways
  • Biotherapeutic contaminant detection
  • Anti-drug antibody monitoring
  • Low-affinity interactions monitoring
  • Vaccine efficacy testing against Influenza

 

Who Should Attend:

  • Protein therapeutics discovery and development scientists
  • Antibody engineering and protein structure biology scientists
  • Protein characterization researchers and molecular biologists
  • Analytical method development
  • Biotherapeutics Quantitation scientists (PK/TK/PD)
  • Quality control and analysis scientists
  • Cell signaling and disease mechanism of action researchers
  • Infectious disease detection and diagnostics researchers

 

Presentation #1
Kinetic Characterization of Protein-Protein Interactions in Purified Proteins and Bacterial Lysates
Presented by Ryan Case, Senior Scientist, Amgen, Inc.
This talk presents the kinetic characterization of a variety of protein-protein interactions spanning low, medium and high affinity to identify lead candidates in biotherapeutic drug discovery. Kinetic information often reveals details of interactions missed in a purely affinity-based screen that are important in ranking clones. The use of this system for off-rate screening of proteins in bacterial lysates will also be discussed.

Instructor Biography: Ryan Case is a Senior Scientist in the Protein Science department at Amgen. He utilizes biosensor technology for kinetic analysis in order to support both early stage screening and candidate characterization in discovery-level projects and higher.

Presentation #2

Fast Label-free Assay for Quantitation of a Humanized Antibody Therapeutic
Presented by Mark Dysinger, Research Scientist, Pfizer, Inc.
Here we present a strategy and results for the development and qualification of a label-free assay for the quantitation of a humanized antibody therapeutic with reagents previously used in a validated ELISA. Label-free qualification and ELISA validation results are compared, and samples analyzed by the ELISA in support of a toxicokinetic (TK) study are analyzed via the label-free assay. From these results we draw conclusions about the practical quantitative use of the label-free assay in both non-GLP and GLP environments.

Instructor Biography: Mark Dysinger is a Senior Scientist at Pfizer Global Research and Development. His past and current work has involved the evaluation of novel technologies for potential kinetic and quantitative applications. He currently works in the regulated biomarkers area.

Presentation #3
Multi-functional Analysis by Label-free Methods for Bioprocessing, Biotherapeutics and Cell Signaling Pathways R&D
Presented by Sriram Kumaraswamy, Ph. D., Senior Product Manager, forteBIO, Inc.
This presentation describes the functional utility of ForteBio’s Octet platform in cell line development and contaminant detection, antibody engineering, anti-drug antibody monitoring, vaccine efficacy testing against influenza and cellular signaling pathway analysis.   Such a diverse range of capabilities in a single detection platform results from the unique combination of an optical detection technique based on bio-layer interferometry,  a high throughput, automated dip and read assay format and robust biosensors that provide excellent compatibility with complex samples such as cell culture supernatant, cell lysate and serum.  Protein concentrations from the mg/mL range to the sub-ng/mL range, and kinetic parameters such as ka, kd and KD can be measured.   The Octet platform serves as an essential tool for the life sciences R&D community by providing rapid, reliable, cost-effective results in these applications.

Instructor Biography: Sriram Kumaraswamy joined ForteBio, Inc. in 2008 and is the Senior Product Manager for the Octet Platform.  He manages Octet hardware, assay kits and custom services and is the editor of ForteBio’s Interactions newsletter. Sriram conducted post-doctoral work in Chemistry at the University of Arizona and his doctoral work at the University of California at Berkeley.

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