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April 15, 2014 (Vol. 34, No. 8)

Improving HCP Impurity Assessment

  • Large molecule, protein-based biopharmaceuticals can have significant advantages over conventional small molecule pharmaceuticals including greater specificity, lower toxicity, and higher efficacy. Despite their potential advantages, biopharmaceutical and biosimilar drug developers face at least one unique challenge: eliminating residual impurities—i.e., host cell proteins (HCPs)—in the final drug substance. Inability to ...

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