Based on a case study presented in our webinar “Fast tracking clinical success: right Fill & Finish CDMO” by Marie-Sophie Quittet, PharmD, PhD (Head of Strategic Projects, Adragos Jura)
When a small-batch oncology product went off the market for several years due to repeated CMO disruptions, Adragos Jura re-initiated compliant supply across multiple markets with minimal dossier changes and maximum yield from scarce bulk. This concise case study shows how pairing regulatory rigor with agile problem-solving accelerated timelines for a product serving a small patient population.
Discover how our team navigated today’s toughest fill & finish challenges: aligning legacy processes to current expectations (including PUPSIT), preserving limited bulk volume, validating custom stopper machinability and closure integrity, planning for a >90-hour lyophilization cycle, implementing robust QA and traceability for blood-derived materials, dual-sourcing sterilizing filters during pandemic-era shortages, and simplifying VAT through inward processing with transparent API consumption tracking.
You will see the practical steps that made the difference: rigorous gap assessment and APS alignment, targeted lab development to set a precise post-filtration discard volume, smart campaign planning, and close sponsor–QA collaboration for a smooth variation submission and inspection. The result: accelerated implementation, preserved bulk, dossier stability, resilient supply, and an ongoing partnership that continues to address new analytical needs with confidence.
Download the case study now:
Get the PDF to learn the framework, decisions, and data that helped restart a complex small-batch oncology product fast and compliantly. Includes a practical checklist of questions to ask a Fill & Finish CDMO before selecting them.
