Abstract
Publisher Summary This chapter discusses the analysis of protein impurities in pharmaceuticals derived from recombinant DNA. Numerous methods exist for determining the protein purity and impurity profile of biopharmaceuticals derived from recombinant DNA. These methods are both qualitative and quantitative in nature and span four different types of analytical technologies. The reasonable detection limits for protein impurities via these technologies are presented in the chapter. No single method or technology is sufficient to give a complete purity assessment or impurity profile for any particular recombinant therapeutic. Instead, several methodologies must be utilized orthogonally—that is, those that separate and detect protein impurities based on different physicochemical properties. A prudent approach would be to utilize reversed-phase high-performance liquid chromatography, capillary zone electrophoresis, and an immunoassay. This tripartite attack would resolve protein impurities based on hydrophobicity, charge-to-mass ratio, and antibody recognition, respectively. With validated assays in each of these disciplines, it is somewhat unlikely that any detectable impurity would not be resolved from the protein drug product or other impurities. However, impurities below the sensitivity limits will remain undetected.
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