2026 AGENDA

CPHI Worldwide

- 6, 7 & 8 October -

Milano (Italia)

¿What is LyoFlow?

Process Analytical Tool implemented at any type of freeze-dryer allowing the measurement of the Vapor Mass Flow Rate

Treatment of the data obtained during a freeze-drying cycle to promote the process development under Quality by Design approach

What is expected of your
lyophilization process?

NEW FREEZE-DRYING PARADIGM BASED IN ICH Q8

Scientific understanding of product development & process gives opportunities to develop more flexible regulatory approaches. FDA, EMA and the Regulatory Agencies are bringing significant benefits for those who develop their processes under Quality By Design:

· Full knowledge of the process. Easify the scale-up & process optimization.

· Risk-based regulatory decisions. Manufacturing process improvements, within the approved design space, without further regulatory review.

· Reduction of post-approval submissions.

· Reduction of end-product release testing.

FAQS

What is the average duration for the approval submissions regarding a process tech transfer from one Freeze Dryer to another? Which is the duration for the same approval submission for a process developed under Quality By Design?

Do you know the lyophilization process limitations of your product? Have you determined the Rp of your product (resistance to the mass transfer of water vapor through the dried layer of the product coefficient)?

Have you determined the Choke Flow limitations of your Freeze Dryer and how it could help you to avoid tech transfer, process development and production problems in your product?