Monday, October 31, 2011 - Tuesday, November 01, 2011
On behalf of the organizing committee, we are excited to welcome you to Bioassays 2011, now in its third year, and look forward to your participation October 31 and November 1 at the Lister Hill Auditorium on the NIH Campus in Bethesda, Maryland. In two short years Bioassays has quickly established itself as a unique opportunity for participants to gain current regulatory and industry insight regarding bioassays. This year's meeting will continue to build on the information and momentum from the 2010 meeting. Bioassays are the foundation by which analytical control strategies are built. The ability of this assay to characterize and demonstrate biological activity is essential. Molecules being developed can be very complex or have multiple modes of action. Companies are challenged with developing assays that are biologically relevant for the analysis of these different mechanisms. These methods are used for lot release, stability, and/or characterization. Therefore, these methods must be robust and, in most cases, suitable for a QC lab. The session topics for this year’s meeting were drawn from suggestions from the participants of the 2010 meeting.
- Bioassays for Complex Products
- Practical Challenges of Routine Bioassays
- Concepts & Strategies for Robust Bioassays
- Fc Effector Functions Analysis
The meeting will be structured to allow multiple opportunities for the participants to interact. Each session includes a panel discussion time following the case study presentations. This will allow for robust dialogue between attendees from academia, industry and regulatory agencies on each session topic. In previous meetings this has resulted in additional focus on the technical and regulatory details of the topic. This year's program has over ten regulators from Europe and the FDA participating as speakers or panelists.