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Part 2: Physicochemical characterization of bevacizumab in 2 mg/mL antibody solutions as used in human i.v. administration: Comparison of originator with a biosimilar candidate.
Journal article

Part 2: Physicochemical characterization of bevacizumab in 2 mg/mL antibody solutions as used in human i.v. administration: Comparison of originator with a biosimilar candidate.

  • Arvinte T Therapeomic Inc., BioPark Rosental WRO-1055, Mattenstrasse 22, 4002 Basel, Switzerland; Department of Pharmaceutical Sciences, University of Geneva - University of Lausanne, Rue Michel Servet 1, 1211 Geneva, Switzerland. Electronic address: tudor.arvinte@unige.ch.
  • Palais C Therapeomic Inc., BioPark Rosental WRO-1055, Mattenstrasse 22, 4002 Basel, Switzerland.
  • Poirier E Therapeomic Inc., BioPark Rosental WRO-1055, Mattenstrasse 22, 4002 Basel, Switzerland.
  • Cudd A Therapeomic Inc., BioPark Rosental WRO-1055, Mattenstrasse 22, 4002 Basel, Switzerland.
  • Rajendran S Apobiologix Inc., Toronto, Ontario, Canada.
  • Brokx S Apobiologix Inc., Toronto, Ontario, Canada.
  • Dowd J Apobiologix Inc., Toronto, Ontario, Canada.
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  • 2019-08-26
Published in:
  • Journal of pharmaceutical and biomedical analysis. - 2019
Bevacizumab
Biosimilar
Dilution
Monoclonal antibody
Physicochemical comparison
Protein aggregation
Administration, Intravenous
Antibodies
Antineoplastic Agents, Immunological
Bevacizumab
Biosimilar Pharmaceuticals
Drug Stability
Humans
Protein Aggregates
Protein Structure, Secondary
English The physicochemical properties of Avastin® manufactured in the USA (Originator USA) and in Europe (Originator EU) and ABX-BEV, a bevacizumab biosimilar drug product candidate produced by Apobiologix Inc., were characterized at a clinically relevant concentration of 2 mg/mL following dilution of the 25 mg/mL drug products with 0.9% NaCl. Measurements using 14 orthogonal analytical methods performed within 5 h after dilution showed good similarity of the three antibodies as regards secondary structure, conformation, aggregation properties, subvisible and visible particles. No significant protein aggregation was observed within 5 h at 24 °C in the 2 mg/mL bevacizumab solutions. The same solutions that were measured within 5 h after dilution were analyzed again after 24 h overnight refrigeration at 2-8 °C: all 2 mg/mL bevacizumab solutions showed an increase in the number and sizes of aggregates, especially the particles larger than 10 μm and 25 μm. The data show the very good similarity in the physicochemical properties of ABX-BEV with Originators USA and EU at a clinically relevant concentration.
Language
  • English
Open access status
hybrid
Identifiers
Persistent URL
https://sonar.ch/global/documents/46545
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