Discovery-Manufacturing Collaboration

Overview

Drug discovery framework that aligns antibody discovery with manufacturing from the outset — shared purification platforms, CHO cell lines with single-site integration, miniaturized manufacturing assays, selectivity panels, and mechanistic PK/PD modeling — to prevent late-stage attrition and deliver patient-friendly subcutaneous formulations. Before 2010 the speaker's team used 293-cell transient expression, protein A-SEC purification, and minimal characterization before handing molecules to manufacturing, which then spent months remediating problems; a concrete failure was an antibody with irreducible multiple SEC peaks that returned to discovery after six months. The redesigned collaboration aligned two-step purification processes matching manufacturing, shared CHO lines with single-site integration or multiple landing pads, miniaturized manufacturing assays for biophysical characterization, broader selectivity testing, and mechanistic PK/PD modeling from the discovery phase, reducing manufacturing timelines and cost. (Pre-2010 Discovery Process (20:00-25:00))