Advancements in High-Resolution Analytics for Characterization of Innovator and Biosimilar Therapeutics

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Scott Berger, Waters Corp.
Originally published in Biopharm International
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White Papers

As the pharmaceutical industry continues to evolve its focus from small molecule drugs to balanced portfolios with protein therapeutics, analytical chemists are increasingly challenged to produce routine and automated characterization workflows that move innovator and biosimilar biopharmaceutical products forward through development and commercialization.

In the following biosimilar comparability study of infliximab performed by Waters scientists, three batches of innovator infliximab (produced in the SP2/0 murine cell line) and three batches of a candidate biosimilar infliximab (CHO cell derived) were compared using the Waters Biopharmaceutical Platform Solution with UNIFI.

Samples were analyzed at the level of the intact protein, protein subunits, protein digest, released glycan fraction, and for aggregation and charge variant profiles. In most workflows, each of the six samples was analyzed in triplicate to establish baseline analytical reproducibility. We review how analytical LC and MS technologies combine with software and informatics to facilitate biosimilar development at three levels:

  • Intact protein and subunit analysis
  • Peptide mapping, reduced and non-reduced
  • Glycosylation, aggregate, and charge variant analysis

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