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The revisions address five areas: submission of recombinantly, synthetically or semi-synthetically produced peptides as abbreviated new drug applications, innate immune response testing, impurity thresholds, higher order structure assessment, and biological activity assessment
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However, the polyArg-tag/cation-exchange resins affinity pair shows low selectivity and the tag promotes aggregation of the protein due to charge–charge interactions (Hedhammar et al., 2005)
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