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Physicochemical and biological assays for quality control of biopharmaceuticals: Interferon alfa-2 case study.

Silva, M M C G*; Lamarre, B; Cerasoli, E; Rakowska, P; Hills, A; Bailey, M J A; Wheeler, J X*; Burns, C J*; Gaines-Das, R E*; Jones, C*; Robinson, C J* (2008) Physicochemical and biological assays for quality control of biopharmaceuticals: Interferon alfa-2 case study. Biologicals, 36 (6). pp. 383-392.

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Abstract

A selection of physicochemical and biological assays were investigated for their utility in detecting changes in preparations of Interferon alfa-2a and Interferon alfa-2b (IFN-a2a, IFN-a2b), which had been subjected to stressed conditions, in order to create models of biopharmaceutical products containing product-related impurities. The stress treatments, which included oxidation of methionine residues and storage at elevated temperatures for different periods of time, were designed to induce various degrees of degradation, aggregation or oxidation of the interferon. Biological activity of the stressed preparations was assessed in three different in vitro cell-based bioassay systems: a late-stage anti-proliferative assay and early-stage assays measuring reporter gene activation or endogenous gene expression by quantitative real time Reverse Transcription-Polymerase Chain Reaction (qRT-PCR). Relevant physicochemical methods such as SDS-PAGE, reverse phase (RP) chromatography, size-exclusion chromatography (SEC) and dynamic light scattering (DLS), proved their complementarity in detecting structural changes in the stressed preparations which were reflected by reductions in biological activity.

Item Type: Article
Keywords: Interferon, Bioassay, Dynamic light scattering, Biopharmaceutical, qRT-PCR
Subjects: Biotechnology
Biotechnology > Biopharmaceutical Manufacturing and Characterisation
Last Modified: 02 Feb 2018 13:15
URI: http://eprintspublications.npl.co.uk/id/eprint/4287

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