A Novel Approach for the Assessment of Insulin Potency by Glycemic Monitoring of an Insulin-Dependent Human Cell Line

摘要

Insulin therapy for people with diabetes encompasses an enormous number of different choices for formulations of insulin and its analogs.1 For quality assurance of biopharmaceutical products, reliable and validated analytical methods are required. Biological assays play an important role for determining the potency of hormones like insulin in living subjects.2,3 Concerning insulin bioassay requirements, regulations differ especially between European and US pharmacopoeias, where for the latter animal based so-called bioidentity testing assures the potency of insulins.4 The European pharmacopoeia does not demand for a bioidentity test. Their quality assurance is solely based on a high-performance liquid chromatography method quantifying total insulin but not necessarily discriminating from, e.g., misfolded fractions. Recently, a replacement of the US pharmacopoeia “rabbit blood sugar method” by an in vitro cell test has been suggested.5