Fill-finish is never “just” fill-finish.
As
Carole Delauney highlights, sterile injectable manufacturing has evolved into a highly interconnected system where drug substance, primary packaging, fill-finish, device assembly, sterilization, and final configuration are all tightly interdependent.
In practice, especially in areas like intravitreal (IVT) products, a decision on something as “simple” as a prefilled syringe format can cascade across line compatibility, sterilization method (EO, VHP, NO₂), packaging configuration (e.g. blister systems), and component lead times, which can reach ~40–50 weeks for custom parts.
The most effective CDMO and supply strategies increasingly come from partners who can:
- Understand the full end-to-end manufacturing chain
- Anticipate interface risks early
- Coordinate across multiple specialist suppliers
- Be transparent about real manufacturing constraints
As Carole notes, integrated thinking reduces development risk.
Full article here:
https://lnkd.in/g9ZjeNBe
Carole will be leading a panel at CDMO Live Europe, Rotterdam, May 19-21st titled: Mastering the Drug Substance to Fill Finish Journey for Biologics: From Cell Line Development to Vial
#fillfinish #CDMO #pharmaceuticalmanufacturing #combinationproducts