期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 102, 期 -, 页码 144-149出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2014.09.007
关键词
Surface plasmon resonance; Activity assessment; Bispecific antibody; Binding assay; Bridging assay
Surface plasmon resonance (SPR) is increasingly applied in drug discovery, early development and production. However, there are remarkably few reports describing the application of SPR in a regulated environment. Here, we describe a novel SPR-based assay, which enables us to assess the binding activity of a bivalent-bispecific anti-Ang-2/anti-VEGF antibody to both targets in a single setup. Validation of the assay revealed a high level of precision, accuracy, linearity and specificity. Upon analysis of temperature stressed samples it could be shown that firstly, the assay is able to indicate function-loss and secondly, it allows the parallel analysis of an additional interaction. Therefore, the described assay is highly suitable for quality assessment of the Ang-2/VEGF CrossMab. Additionally, the use of SPR in the context of assay development and routine use in a GMP environment is discussed. (C) 2014 Elsevier B.V. All rights reserved.
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