Analytical characterization of biosimilar antibodies and Fc-fusion proteins

作者：Beck Alain^*; Diemer Helene; Ayoub Daniel; Debaene Francois; Wagner Rousset Elsa; Carapito Christine; Van Dorsselaer Alain; Sanglier Cianferani Sarah

来源：TrAC-Trends in Analytical Chemistry, 2013, 48: 81-95.

DOI：10.1016/j.trac.2013.02.014

• Biobetter
• Biosimilar
• Cetuximab
• Critical quality attribute (CQA)
• Etanercept
• Fc-fusion protein
• Mass spectrometry (MS)
• Rituximab
• Therapeutic antibody
• Trastuzumab

Mass spectrometry (MS) is one of the key analytical techniques to detect and to identify primary sequence differences, to assess similarity and to evaluate batch variability of reference monoclonal antibodies (mAbs). The next generation of high-resolution mass spectrometers and the early use of improved MS-based methodologies will help bring biosimilar mAbs and Fc-fusion proteins into highly regulated markets.

• 出版日期2013-8