Strategic Use of Comparability Studies and Assays for Well Characterized Biologicals
	IBC USA Conferences, Inc. , Renaissance Washington D.C. Hotel * Washington, D.C. September 18-21, 2000
	When contracting manufacturing or making process or facilities changes, demonstrating comparability is critical to save time and avoid costly new clinical studies. Regulations regarding process changes for biopharmaceutical products continue to evolve as analytical technologies advance to reach startling levels of accuracy in protein characterization. IBC's international conference on Well Characterized Biologicals brings together world leaders in regulatory affairs, manufacturing and analytical technologies to give you a comprehensive, up-to-the-minute update on these changes. The information you gain by attending can give your organization's manufacturing operations a competitive edge. Hear from regulators and senior industrial regulatory affairs experts from the U.S., Japan, Europe, and Canada, and ask your questions in roundtable discussions. The regulatory strategy session will give the latest news on comparability and comparability protocols, specifications, immunogenicity, post-approval changes, and the use of biological assays. Recent case studies from Amgen, Genentech, Biogen and Hoffmann-LaRoche will document the use of comparability protocols and studies in securing global approvals and effecting manufacturing changes. Reports will cover: PEG conjugates * protein conformation measurement * antigenicity assays to predict immunogenicity * glycobiology considerations for PK. Scientists from MedImmune, Immunex, Merck, Amgen and Genetics Institute/Wyeth Ayerst detail their use of the newest analytical technologies and assays including: CE * evaporative light scattering detectors * SPR assays for product concentration and binding characterizations * mass spectrometry * static light scattering * field flow fractionation * atomic force microscopy * HPLC * ion exchange chromatography. Benefit from exactly the programming that meets your needs by selecting any two, three, or all four days. Present a poster to enhance the value of your participation. Register now to ensure your space.
	Organized by:	IBC USA Conferences, Inc.
	Deadline for Abstracts:	-
	Registration:	Five Easy Ways to Register! Phone (508) 616-5550 Fax (508) 616-5533 E-mail reg@ibcusa.com Online www.ibcusa.com/2526 Mail: IBC USA Conferences, Inc. 1 Research Drive, Suite 400A Westborough, MA 01581
	Email for Requests and Registration:	jprudhomme@ibcusa.com
	Posted by: James Prudhomme   Host: 209.6.93.46 date: May 17, 2000 20:39:07 Generated by meetings and positions 2.0 by Kai Garlipp Logo and Logo Images by Art for BioMed / Syrinx GmbH - Frankfurt / Germany. 4.1 (c) 1995-99 HUM-MOLGEN. All rights reserved. Liability and Copyright.