Goals and Objectives:
- To provide a forum for discussing the latest bio-analytical methods and their practical application to biotechnological pharmaceuticals and other health-related products.
- To provide a forum for open discussion between regulators of biotechnology-derived drug products (BPs) and developers of analytic methodologies for the development of BPs.
- To seek feedback from industry, academia, government, and other stakeholders on advancements in bio-analytical methods and their application to BPs.
- Promote the efficient development of BPs, including FDA=regulated therapeutic protein products and matters related to their development and regulation, such as novel analytical technologies, manufacturing issues, control strategies, immunogenic assessment, and sterility assistance issues.
- Facilitate open discussions among the pharmaceutical / biotechnology industry and academic attendees and FDA and international regulatory staff.
- To provide a forum to discuss among the pharmaceutical / biotechnology industry and academic attendees and FDA and international regulatory staff.
- To provide a forum to discuss the scientific technical issues concerning characterizing complex biotechnology derived health products through panel discussions, presentations, and workshops.
- To provide a venue for professionals to present their most current data and thoughts on BP analysis and regulation, with data presented in poster sessions.
- To provide an opportunity for networking with other scientists.