The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - Part 1: Higher molecular weight species and subvisible particle formation

• Main Authors: Oliver Bluemel (Author), Moritz Anuschek (Author), Jakob W. Buecheler (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.

Cryoconcentration upon large-scale freezing of monoclonal antibody (mAb) solutions leads to regions of different ratios of low molecular weight excipients, like buffer species or sugars, to protein. This study focused on the impact of the buffer species to mAb ratio on aggregate formation after froz...