John A. Latham1, Brain Kovacevich1, Patricia McNeill1, Gary Lesnicki2, Leon Garcia-Martinez1, Ethan Ojala1, Sam Marzoff1, Katie Olson1, Anne Jensen1, Pat Moss1, James Cregg3, and Ilya Tolstorukov3. (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, (3) Keck Graduate Institute of Applied Life Sciences, 535 Watson Dr., Claremont, CA 91711
Monoclonal antibody products have become an important product group in the pharmaceutical industry and 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 robust technology platform for the discovery of novel therapeutic antibodies and the rapid production of full-length humanized antibodies products in Pichia pastoris. 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. This presentation will outline the strategy and implementation of this platform to support the development ALD 518.