The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - part 2: Aggregate formation and oxidation

• Main Authors: Oliver Bluemel (Author), Jakob W. Buecheler (Author), Astrid Hauptmann (Author), Georg Hoelzl (Author), Karoline Bechtold-Peters (Author), Wolfgang Friess (Author)
• Format: Book
• Published: Elsevier, 2022-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

We examined the impact of monoclonal antibody (mAb) and buffer concentration, mimicking the cryoconcentration found upon freezing in a 2 L bottle, on mAb stability during frozen storage. Upon cryoconcentration, larger protein molecules and small excipient molecules freeze-concentrate differently, re...