ANALYSIS OF A VACCINE PURIFICATION PROCESS BY CAPILLARY ELECTROPHORESIS

Free-zone capillary electrophoresis (CZE) was applied to the analysis of samples from the individual purification steps in the production of a licensed vaccine product. With this technique, real-time analysis can be performed to ensure that purification parameters are being met before proceeding to the next step. In addition to monitoring the product peak, a unique pattern of associated host cell contaminants also is displayed. This unique ''fingerprint'' at each step of the purification process may have practical utility for production in that it demonstrates lot-to-lot consistency in the manufacturing process of the vaccine.