Title: Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars
Authors: Tebbey, Paul ×
Declerck, Paul #
Issue Date: Jul-2016
Publisher: Generics and Biosimilars Initiative
Series Title: GaBI - Generics and Biosimilars Initiative Journal vol:5 issue:2 pages:70-73
Abstract: The clinical performance of biological therapies is affected by their manufacturing processes. The advent of biosimilars increases the need to understand the clinical impact of potential differences versus originator products. We review important recently published technical data on adalimumab consistency and manufacturing experience from a clinical perspective, including the implications for immunogenicity when there are changes to a tightly controlled manufacturing process that may lead to variations in the epitopes of biological therapies.
ISSN: 2033-6403
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Therapeutic and Diagnostic Antibodies (+)
× corresponding author
# (joint) last author

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