RECOMBINANT HUMAN INSULIN .3. HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY AND HIGH-PERFORMANCE CAPILLARY ELECTROPHORESIS CONTROL IN THE ANALYSISOF STEP-BY-STEP PRODUCTION OF RECOMBINANT HUMAN INSULIN

The production of recombinant human insulin consists of five main stag es, accompanied by considerable transformation of molecules, concernin g size, secondary structure and the presence of charged groups. The ap plication of different methods, i.e., size-exclusion, ion-exchange and reversed-phase high-performance liquid chromatography (HPLC) and high -performance capillary electrophoresis (HPCE) (capillary zone electrop horesis and micellar electrokinetic capillary chromatography), to the analysis of insulin, insulin-related and non-insulin-related substance s was studied. A combined HPLC-HPCE system for the step-by-step contro l of recombinant human insulin production technology is suggested. The advantages and shortcomings of these methods are discussed.