Designing Drug Substance Processes For Fill-Finish Compatibility

Ensuring a smooth transition from drug substance development to fill‑finish manufacturing is essential to keeping programs on track, yet many teams still encounter avoidable delays. Misaligned quality processes, limited visibility across partners, and unclear ownership of cross‑functional issues often create bottlenecks that slow or jeopardize progress. This session explores how an integrated, end‑to‑end approach can eliminate these barriers and optimize both timelines and outcomes.

Through an open fireside conversation, industry experts will outline the most common quality challenges that arise when coordinating between development and fill‑finish operations. They’ll share practical strategies for improving communication, managing shared deviations, reducing downstream rework, and building alignment on requirements earlier in the process.

Attendees will gain actionable insights to streamline handoffs, minimize risk, and accelerate the path from cell line development to final drug product—ultimately improving program predictability and shortening overall development timelines.