Integrating Drug Substance And Drug Product To Reduce Risk Across Development

Drug substance and drug product have long been developed as separate activities, and that model has supported many successful programs. Yet each interface adds its own schedule, quality system, analytical approach, and layer of contingency, and the effects accumulate.

Dörthe Ackenhausen, Head of Client Program Management at IDT Biologika, argues that the case for integration reaches well beyond consolidating providers. She looks at how target product requirements should inform early process decisions, why sensitive viral products are especially exposed to handoffs, and how shared analytics and governance support clearer investigations. The paper also considers clinical programs designed with commercial reality in mind, and what is lost when late-stage transfers arrive without their development history.

Explore the full argument to see how continuity of knowledge may matter as much as continuity of manufacturing.