At the end of February, sunny southern California will be the site for a week-long conference devoted to the development and production of biopharmaceuticals. IBC’s Biopharmaceutical Development and Production Week will be held in Huntington Beach, California, and runs from February 25-March 1. The conference is exceptionally broad in its coverage, ranging from sessions on raw material characterization and risk assessment, through sessions focused on development and production of particular product types.
As well as technical sessions devoted to upstream and downstream processing, tech transfer, process validation, and protein analytics, the conference will cover regulatory issues surrounding biopharmaceuticals. Jeffrey C. Baker from FDA’s Office of Biotechnology Products will be on hand to deliver a keynote talk on emerging issues in the regulation of biopharmaceuticals. Within the Viral Safety for Biologicals track, representatives from and EU and FDA will discuss regulatory issues for adventitious agent testing.
The second half of the week delves more deeply into production challenges for specific product classes. An entire track is devoted to antibody drug conjugates, with a keynote talk on characterization and comparability strategies being given by Fred Jacobson, PhD, from Genentech (a member of the Roche group). In addition, scientists from ImmunoGen, Pfizer, and Seattle Genetics will discuss analytical strategies for antibody-drug conjugates, and scientists from Ambrx, Sutro BioPharma, and Mersana Thersapeutics will give presentations on novel conjugation strategies.
Barry Walsh, Conference Director and Project Leader at IBC Life Sciences spoke with me in detail about the organization of the conference. You can listen to his podcast to hear a more complete description of the sessions that will be presented.