BioAnalytical Method Development 
Workshops
| Workshops Monday, October 6, 2008 |
| Workshop B1 Development, Validation and Assessment of Relative Potency in Cell-Based Bioassays |
| 9:00 |
| Workshop Registration and Morning Coffee |
| 9:30 |
| Chairpersons Opening Remarks - Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE |
| 9:45 |
| Phase-based Approach in the Development of Potency Assays for a Monoclonal Antibody Protein Therapeutic The biological activity of a monoclonal antibody product developed by Biogen Idec was assessed using various assay formats based on the clinical stages of drug development. Earlier this phase-based approach for the bioassay development was successfully implemented for at least two Biogen Idec products. A panel of potency assays was developed to assess the biological activity of monoclonal antibody product. The selection of the assay format was based on the product development stage. For early stage of the product development, a binding assay was developed in an ECL-based MSD format. For a later stage of product development, cell-based bioassays which reflect the mechanism of action were considered to assess the potency of the antibody molecule. In a parallel manner, we developed and compared various assay formats utilizing the inhibitory effect of drug product on the down stream cell-signaling events such as phosphorylation and transcriptional activation. The criteria for the selection of one of these formats for batch release and stability testing will be discussed. - Velvizhi Heine, Scientist II, BIOGEN IDEC |
| 10:30 |
| 30-Minute Networking Break |
| 11:00 |
| Development of a Cell-based Phosphorylation Assay for the Potency of a Monoclonal Antibody Product against a Cell Surface Receptor This case study describes the development and qualification of a cellbased assay for determining the potency of an antibody on receptor phosphorylation/activation. Biogen Idec has developed a monoclonal antibody product against a cell surface receptor. In order to examine the potency of this antibody in the receptor-mediated cell signaling, we have developed a receptor phosphorylation assay to evaluate inhibition of the receptor phosphorylation response elicited by the receptor ligand. The goal for this work was to develop a QC-friendly assay with a high signal/noise ratio and short assay time. The development process included optimizing the cell treatment conditions and choosing the optimal assay format. Assay qualification (accuracy, intermediate precision, linearity and specificity) will also be presented. - Wei Zhang, Scientist II, BIOGEN IDEC |
| 12:00 |
| Luncheon for Presenters and Workshop Attendees |
| 1:30 |
| OPEN SESSION |
| 2:30 |
| 30-Minute Afternoon Break |
| 3:00 |
Strategies for Potency Assays Challenges
- Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE - Velvizhi Heine, Scientist II, BIOGEN IDEC - Wei Zhang, Scientist II, BIOGEN IDEC |
| 4:00 |
| Workshop Concludes |
| Morning Half Day: Workshop B2 Fundamentals of Ligand Binding Assays |
| 9:00 |
| Workshop Registration & Morning Coffee |
| 9:30 |
| Workshop Begins |
| 10:30 |
| 30-minute Networking Break |
| 12:00 |
| Luncheon for MorningWorkshop Attendees and Presenters The intrinsic complexity of protein-based biotherapeutics and the lack of simple correlations between in vivo efficacy and in vitro binding affinities create challenges in generating and interpreting data on molecular interactions. This half day workshop is a great introduction or refresher on the basic principles of ligand binding assays to help prepare you for the in-depth topics being discussed during the main conference sessions. Workshop Leaders - Linda Zuckerman, PhD, Director, Portfolio and Program Management, ZYMOGENETICS - Susan Pederson, Associate Director, PreClinical Development, ZYMOGENETICS |
| Afternoon Half Day: Workshop B3 Fundamentals of Fc Effector Functionality Principles |
| 1:00 |
| Afternoon Workshop Registration |
| 1:30 |
| Workshop Begins |
| 2:30 |
| 30-minute Networking Break |
| 4:00 |
| Workshop Concludes Monoclonal Antibodies (MAbs) are an important class of therapeutic biologics and Fc functions are frequently important for mechanism of action and also may drive PK and/or safety signals. Fc regions of MAbs are often engineered to enhance efficacy, as well as to alter PK and/or safety profiles. However, methods for in vitro assessment of Fc effector functionality are rarely discussed. There are many possible in vitro ways to assess Fc functionality, but best practices have not been defined. It is also not clear how data from these in vitro analyses relates to efficacy or toxicity in vivo. Join us for this half-day workshop focusing on the basics of how to assess Fc functionality. Workshop Leaders - An Song, PhD, Senior Scientist/Group Leader, BioAnalytical Research & Development, GENENTECH - Jaya Goyal, PhD, Associate Director, Clinical Science and Technology, BIOGEN IDEC |
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