MASTERCLASS WEBINAR
Where Pre-Filled Syringe Tech Transfers Go Wrong
How to Avoid the Hidden Risks From Development to Commercial Supply Under Annex 1
A live webinar masterclass on how to move from development into commercial pre-filled syringe manufacturing and what Annex 1 changes for European sterile fill-finish.
Hosted with Siegfried and SKAN
Most products run through development in vials. The move into commercial pre-filled syringe (PFS) manufacturing is where the earlier formulation and device decisions catch up, and where transfer projects lose time.
Annex 1 has changed what a European sterile fill-finish site has to demonstrate. It is also changing how sponsors evaluate where commercial PFS capacity should sit, at the same time as sterile supply shifts from global sourcing toward regional sourcing.
This session covers the path from development to commercial PFS supply: when PFS comes into play, where transfer projects encounter difficulty, what it takes to deliver on time and in full, and what Annex 1 means for the European sterile fill-finish landscape.
What the session covers
- How PFS tech transfers are evolving and what sponsors now require from a receiving site
- Where PFS transfer projects encounter difficulty, and what a successful transfer looks like
- How to speed up transfers and deliver on time and in quality
- What Annex 1 changes for European sterile fill-finish, and the geopolitics affecting sterile supply chain decisions
