Plan now to attend this highly technical conference for just the right mixture of practical tools, regulatory trend overviews, emerging technologies, and product case studies. Bioassay scientists are intensifying their use of new technologies. Quality by design validations are becoming common, with statistical tools implemented during development, and cells are being developed for single-use applications. This is the must-attend event for bioassay professionals who want to keep up with these changes — where scientists gather to discuss how to overcome real technical obstacles.
If you are involved in developing critical assays, attend this meeting to find out new approaches and hear practical discussions centering on real-world problems and solutions. Learn how to get assays approved and functioning with today’s technologies. This conference focuses on tools you need to develop biological assays quickly and efficiently for successful product development.
Knowing what is state-of-the-art and expected by regulators is vital to developing bioassays for use in a quality control laboratory — for products based on monoclonal antibodies, rDNA, vaccines, and toxins. Discover practical approaches that can be applied immediately. Who Should Attend
This practical and technical conference is designed for scientists, analysts, assay statisticians, and managers who work with biological assays during biopharmaceutical development or routine product release. Regulatory and quality assurance professionals who submit or oversee complex assays will also gain valuable insight. Sessions
- Dealing with Animal Potency Assays
- The Evolving Art of Measuring Antibodies in Serum
- Potency Assays for Multifunctional Antibody Products
- How Consistent Is Your Assay?
- Developing Multiproduct Host-Cell Protein Assays
- Assay Components: The Devil Is in the Details
“Ten-Year Review of Potency Assays from an FDA Reviewer’s Perspective,” by Gerald Feldman (CDER, US FDA)
“Update on the USP Chapters on Biological Assays,” by Timothy Schofield (Arlenda)
“Bioassay Design,” by David Lansky (Precision BioAssay)
“Industry White Paper on Implementing Surrogate Assays for ADCC Methods,” by Svetlana Bergelson (Biogen Idec) and Xu-Rong Jiang (MedImmune) New This year
In a 10-year look back, an FDA reviewer who spoke at one of the first Bioassay conferences will articulate new problems and old ones that haven’t gone away.
Learn about the nitty-gritty details of how to perform calculations for the proposed USP-style validation of bioassays: e.g., how to derive the replication/format table from a given validation data set. The chapter is due to be finalized in late 2012, so here is a chance to get ahead of the curve.
And there will be a mini-tutorial on statistical tools for monitoring assays — as well as two case studies on what aspects should be monitored. Attendees Say…
“The combination of statistical method and workshops with case studies give the participants a true grasp of how to apply modeling technologies to assay development and validity.” —Duane Brumm (Baxter)
“Very timely topics and expert speakers that make the topics understandable.” —George Kamplaus (Biogen Idec)
“This is a really practical, useful, and enjoyable conference to anyone — including beginners in the bioassay world.” —Soyoung Yong (Celtrion Inc.)
“The conference tackles key issues concerning all industry bioassay personnel and manages to touch on very familiar problems.” Srinderi Khambhampity (Dr Reddy’s Labs) Preconference Workshops
- Advanced Tools for Assessing and Controlling Assay Variability and Spurious OOS Results
- Bioassay Development Basics 101
Register Early to Save!
Early registration discounts are available. Find complete details online, or call 1-800-309-4078. When registering, please mention this priority code: B12177FE.