Proteins behaving badly: emerging technologies in profiling biopharmaceutical aggregation

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Over recent decades biotechnology has made significant advances owing to the emergence of powerful biochemical and biophysical instrumentation. The development of such technologies has enabled high-throughput assessment of compounds, the implementation of recombinant DNA technology, and large-scale manufacture of monoclonal antibodies. Such innovations have ultimately resulted in the current experienced biopharmaceutical stronghold in the therapeutic market. Yet aggregate prediction and profiling remains a challenge in the formulation of biopharmaceuticals due to artifacts associated with each analytical method. We review some emerging trends and novel technologies that offer a promising potential for accurately predicting and profiling protein aggregation at various stages of biopharmaceutical product design.
Original languageEnglish
Pages (from-to)448-458
Number of pages11
JournalTrends in Biotechnology
Issue number8
Publication statusPublished - 14 Jun 2013


  • aggregation
  • biopharmaceuticals
  • manufacture
  • product development
  • quality by design
  • biopharmaceutical aggregation


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