Water Proton NMR for In Situ Detection of Insulin Aggregates

摘要: The need for quality control during the manufacturing and distribution of biopharmaceuticals is becoming increasingly necessary. At present, detecting drug degradation through monitoring active factor aggregation accomplished "invasive" techniques, such as size-exclusion chromatography (SEC), analytical ultracentrifugation (AUC), so on. Unfortunately, these methods require sampling by opening container that renders remaining unusable regardless outcome test. Visual inspection, current non-invasive method qualitative can only detect visible particulates. Thus, it will miss sub-visible protein aggregates. In this paper, human insulin preparations were used to demonstrate transverse relaxation rate water protons R2 ((1) H2 O) serve a sensitive reliable indicator quantify both measured using wide-bore low-field bench-top NMR instrument with permanent magnets. Such analysis could be carried out without container, thus saving further use. results suggest novel, economical, non-destructive in situ technique allows on-the-site quantification biopharmaceutical products.