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 biophar- maceutical products, reliable and validated analytical meth- ods are required. Biological assays play an important role for determining the potency of hormones like insulin in liv- ing 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-per- formance liquid chromatography method quantifying total insulin but not necessarily discriminating from, e.g., mis- folded fractions. Recently, a replacement of the US phar- macopoeia “rabbit blood sugar method” by an in vitro cell test has been suggested.