Back
Characterization of 30 therapeutic antibodies and related products by size exclusion chromatography: Feasibility assessment for future mass spectrometry hyphenation.
Journal article

Characterization of 30 therapeutic antibodies and related products by size exclusion chromatography: Feasibility assessment for future mass spectrometry hyphenation.

  • Goyon A School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Centre Médical Universitaire (CMU), Rue Michel-Servet 1, 1206, Geneva, Switzerland.
  • D'Atri V School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Centre Médical Universitaire (CMU), Rue Michel-Servet 1, 1206, Geneva, Switzerland.
  • Colas O IRPF, Center of Immunology Pierre Fabre, 5 Avenue Napoléon III, BP 60497, 74160 Saint-Julien-en-Genevois, France.
  • Fekete S School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Centre Médical Universitaire (CMU), Rue Michel-Servet 1, 1206, Geneva, Switzerland.
  • Beck A IRPF, Center of Immunology Pierre Fabre, 5 Avenue Napoléon III, BP 60497, 74160 Saint-Julien-en-Genevois, France.
  • Guillarme D School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Centre Médical Universitaire (CMU), Rue Michel-Servet 1, 1206, Geneva, Switzerland. Electronic address: davy.guillarme@unige.ch.
Show more…
  • 2017-09-26
Published in:
  • Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. - 2017
Aggregates
Antibody-drug conjugates
Bi-specific antibodies
Fc-fusion proteins
Monoclonal antibodies
SEC-MS
Size exclusion chromatography
Animals
Antibodies, Monoclonal
Chromatography, Gel
Humans
Immunoconjugates
Immunoglobulin Fragments
Mass Spectrometry
Mice
Recombinant Fusion Proteins
Temperature
English Despite the popularity of targeted and immune therapies, the number of studies dealing with the quantitation of aggregates for Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved mAb and related products are still very scarce in literature. In this work, 30 therapeutic proteins including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), Fc-fusion proteins and a bi-specific antibody (bsAb) were investigated using size exclusion chromatography (SEC). Their levels of high molecular weight species (HMWS) were experimentally estimated between 0.1% and 13.1%. Except for blinatumomab, etanercept and pembrolizumab, the HMWS amount for the other antibodies was well below the limit of 5% usually set a specification for therapeutic mAbs in the biopharmaceutical industry. The main chromatographic peak shape of 24 therapeutic antibodies and the NIST mAb [1] was found suitable (0.8
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://sonar.ch/global/documents/28925
Statistics
Document views: 8 File downloads: