Development of a microflow digital imagi
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Klaus Wuchner; Jochen Büchler; Rene Spycher; Paul Dalmonte; David B. Volkin
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Article
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2010
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John Wiley and Sons
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English
⚖ 260 KB
The development of a Microflow digital imaging (MDI) method to detect and monitor protein particulates in a high concentration IgG1 monoclonal antibody formulation is presented. The MDI assay was optimized and qualified as a characterization assay in terms of accuracy and precision of particle size