Fill Profile Development Lowers Reject Rate for Lyophilized Product
See how smarter filling saved a biologic from a double-digit reject rate.
A small amount of liquid left on the vial wall can mean a costly reject, especially when a high-value API is on the line. For one client’s high-value biologic, that meant reject rates reaching as high as 13% per batch.
In this case study, you’ll learn how Jubilant HollisterStier’s technical experts:
- Identified the root cause of residue-driven rejects during tech transfer
- Reduced the defect rate from product residue to 1% or less
- Improved batch yield and conserved a high-value API
