Where pre-filled syringe tech transfers go wrong

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.

Topics

Drug Products Pharmaceutical Manufacturing Regulatory support Fill-finish Pre-filled syringes

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About the presenter

Katrin Solmsdorff + Jens Klein + Thomas Zinn

Katrin Solmsdorff is the Head of Project & Program Management at Siegfried’s Hameln site in Germany. She has worked in the pharma industry since 2004, across process validation, technology transfer and project management. Jesn Klein is the echnical Project Manager for PFS at Siegfried, who is building Siegfried’s new PFS filling and visual inspection lines. He spent more than 20 years in production at CDMOs and marketing authorization holders before joining Siegfried. Thomas Zinn serves as the Chief Officer of Aseptic Manufacturing Services at SKAN AG. As pharmaceutical technology engineer, he has served the industry for close to 30 years, working at the interface between development, scale-up and site-to-site transfers.