Thursday, August 14, 2008 - 2:30 PM
S166

Pichia pastoris: A robust expression platform for the rapid production of full-length therapeutic antibodies

John A. Latham1, Patricia McNeill1, Gary Lesnicki2, Leon Garcia-Martinez1, Brian Kovacevich1, Ethan Ojala1, Sam Marzoff1, Katie Olson1, Pat Moss1, and Anne Jensen1. (1) Alder Biopharmaceutical, 11804 North Creek Parkway S, Bothell, WA 98011, (2) Michael Smith Laboratories, University of British Columbia, 2185 East Mall, Vancouver, BC V6T1Z4, Canada

Monoclonal antibody products have become an important product group in the biotech and pharmaceutical industry.  These agents are envisioned to make a significant contribution to the next wave of novel therapeutics. Mammalian protein expression technology has been at the core of producing these drugs.  While this has been the flagship platform, there continues to be a need for alternate strategies that can decrease both the cost and time of bringing a member of this class of therapeutics to the clinic and ultimately to market.  We have developed a rapid, robust technology platform for the discovery of therapeutic antibodies that is paired with a novel Pichia pastoris expression system designed to produce secreted full-length humanized antibodies products.  Together this system dramatically reduces the time from discovery to clinic.  This expression system captures all the attributes provided by this host (low cost, strain stability, etc.) while eliminating product development risk associated with untested expression systems.  These Pichia produced antibodies display identical biochemical and pharmacokinetic characteristics of conventionally produced antibody proteins. The platform has been successfully run under GMP at  2000L scale with excellent reproducibility.  This presentation will outline the strategy and implementation of this platform to support preparation of ADL518 for use in human clinical trials.