David Robbins is a Director in Biopharmaceutical Development at MedImmune/AstraZeneca, leading late-stage purification development for more than 15 years. David has overseen downstream development of approximately 20 monoclonal antibodies and other protein therapeutics, including the recently approved Fasenra and Imfinzi. David initiated and oversaw development of MedImmune’s platform purification process for mAbs, and has co-led the development and implementation of the current MedImmune/AstraZeneca QbD and BLA strategies for Biopharmaceuticals. Prior to joining MedImmune, David was involved in process development for large and small molecules at American Cyanamid/Wyeth, where he was the technical process and manufacturing lead for commercialization of Mylotarg, the world’s first approved antibody-drug conjugate. David holds a B.Ch.E. degree from Georgia Tech, and a PhD from MIT, both in Chemical Engineering.
David is a thought leader in QbD and control strategy for biopharmaceutical processes. He has represented MedImmune/AstraZeneca on the A-Mab QbD Case Study, FDA QbD Pilot Program, and the efpia Support Team to the ICH Q12 Expert Working Group, and represents Biopharmaceutical Development on the AstraZeneca CMC Strategy Board.