Fill-Finish Success:
From Isolator Qualification to GMP Production
About this webinar
Sterile drug product fill-finish is where years of development either pay off or unravel. Partnering with a CDMO that has isolator lines does not guarantee success. The difference lies in the depth of technical and operational expertise behind them.
This webinar will explore why disciplined commissioning and qualification of isolator-based aseptic operations is fundamental to reducing risk before the first batch, how manufacturing strategies hold up against evolving global regulatory standards and what it takes to protect high-value drug products throughout filling.
Register for this webinar to learn how effective fill-finish operations can align quality systems with GMP operational excellence, reduce product loss and convert more of every batch into supply for patients.
Who should attend
- Manufacturing and Operations professionals
- Process Development Scientists
- Quality Assurance professionals
- Emerging biotech companies
- Mid- to large-size pharmaceutical companies
What you will learn
- The importance of robust commissioning and qualification on an isolator line to de-risk the fill-finish process
- Manufacturing strategies to support compliance with global regulatory standards such as Annex 1
- How to minimize product loss and maximize batch yields
Featured Speakers
Riley Bottoms
Partner for this event
MilliporeSigma
MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. We provide solutions to help support your Fill-Finish manufacturing. Our elite, end-to-end CDMO services are backed by decades of specialized experience in complex drug product production. Our Indianapolis Center of Excellence seamlessly bridges the gap between process development, clinical, and commercial scale GMP operations.