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Shimadzu Review 75[3・4] (2018.12)
In recent years, biopharmaceuticals have accounted for a majority of the top 10 sales of the pharmaceutical products. Development of novel biopharmaceuticals is proceeding, and therapeutic modality tends to diversify. Many quality control items are specified in production of protein therapeutics. Aggregates are also evaluated due to a possibility of showing immunogenicity. Epidemiological research has progressed to ensure the safety of biopharmaceuticals, and advances in analytical techniques are also desirable. There is demand for establishment of size characterization methods for sub-visible particle (SVP) that are not subject to quality control at the moment. In this article, we describe a flow field flow fractionation device developed by participating in Manufacturing Technology Association of Biologics (MAB), and show some examples of biological sample analysis performed using a prototype system.
Keywords: Flow field flow Fractionation, Size characterization, Sub-visible particles, Protein aggregates, Extracellular vesicles
1Bio-Industry Unit, Technology Research Laboratory, Shimadzu Corporation, Kyoto, Japan
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