The Minimum Package A CDMO Needs To See

This segment of the Outsourced Pharma Live event, “Charting A Direct Pathway From Academia To CDMOs,” outlines the minimum information an academic or early-stage team should bring to its first serious CDMO discussion. Leonardo identifies a quality target product profile, analytical specifications, upstream and downstream process descriptions, and preliminary analytical method qualification as foundational elements, while Michael stresses the importance of openly explaining how the available data and materials were generated. Featuring Leonardo Sibilio, Ph.D., CEO, Nexantia Biotherapeutics, and Michael Salgaller, Ph.D., Supervisor, Technology Analysis and Marketing Unit, Technology Transfer Center at NCI, NIH.