“You may design for 12 hours,” says Xufeng Sun, Vice President of Manufacturing Science & Technology at Sharp Sterile, “but you better be prepared for 24.” It’s a line that perfectly captures the theme of Episode 2 of Our Experience is Your Strength, where host Steve Jacobs explores the unpredictable terrain of gene therapy fill & finish with one of the industry’s most experienced hands.
Episode 2 – High value, low loss: Developing a successful GT fill & finish strategy
Drawing on over two decades in biopharma and six years at Sharp Sterile, Sun shares real-world scenarios that highlight the delicate balance between precision and flexibility in gene therapy manufacturing.
Listen to episode two below:
In one striking example, a client’s fill-finish process, initially designed for a 12-hour turnaround, was unexpectedly extended to 20 hours. The batch was saved, but the lesson was clear: gene therapy doesn’t always run on schedule, and the cost of unpreparedness and no contingency plan can be enormous.
The conversation goes beyond cautionary tales. Sun breaks down the four key steps to building a successful fill-finish strategy and emphasizes that, with limited drug substance and tight storage requirements, the margin for error is razor-thin. Even something as seemingly simple as thawing can become a critical hold point, especially when timelines clash with equipment readiness or batch size changes.
This episode is an essential listen for drug developers navigating the complexity of filling high-value, low-loss therapies, offering a practical, experience-driven framework for success, and a compelling case for why, in gene therapy, what you don’t plan for can hurt you most.
This podcast is the second instalment in a series by Sharp, titled Our Experience is Your Strength. Across the episodes, host Steve Jacobs is joined by seasoned experts in formulation, sterile manufacturing, clinical supplies, commercial packaging, and sustainability to explore a range of challenges across drug development and commercialization, with a focus on getting the best results through contract services. Each episode draws upon key learnings gathered across Sharp’s decades of experience as a CDMO, helping to set listeners up for success with their chosen vendor.
