4th Annual Cell Based Assays 
Workshop
B1: FULL DAY WORKSHOP | |
| 9:00 | Workshop Registration |
| 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 cell based 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 Presenters and Workshop Attendees |
| 1:30 | Strategy for Selection of Potency Assays for Therapeutic Monoclonal Antibody Development Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE |
| 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 |
B2: MORNING WORKSHOP | |
| 9:00 | Workshop Registration & Morning Coffee |
| 9:30 | Workshop Begins |
| 10:30 | 30-minute Networking Break |
| 12:00 | Luncheon for Morning Workshop 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 Susan Pederson, Associate Director, PreClinical Development, ZYMOGENETICS | |
B3: AFTERNOON WORKSHOP | |
| 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 access Fc functionality. Workshop Leaders An Song, Senior Scientist/Group Leader, Development Sciences, GENENTECH Jaya Goyal, PhD, Associate Director, Clinical Science and Technology, BIOGEN IDEC | |
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