Lyo Cycle Development Ensures Success for Oncology Drug Scale-Up
Find out how engineering-led cycle development bridged the gap from benchtop to validated-scale up.
What works on a benchtop doesn’t always survive the jump to a large-scale lyophilizer. See how JHS engineers identified the root cause of a failed PPQ validation run and recovered the process without sacrificing cycle time.
What you’ll learn:
- Why a failed pressure rise test stopped production
- How a data-driven engineering review pinpointed the adjustment needed
- The outcome: a robust, validated lyo cycle that passed all three PPQ batches
- How isolator-based fill-finish with ALUS maintained sterility throughout
