Abstrakt

Development of Quantitative Residual Acetate and Phosphate Assay in Multi Vaccine Products Using Capillary Zone Electrophoresis

Brian Peklansky, Melissa Hamm, Carrie L. Anderson, Sean Oriana and Richard R Rustandi

Some vaccine process manufacturing techniques require the use of acetate (Ac) and phosphate (Pi) containing buffers to complete biochemical reactions prior to downstream product purification. These two anions must be removed from the final bulk product, which necessitates the need for an assay to monitor Ac and Pi reduction throughout. Due to the separation speed, low volume consumption, and resolving power, a capillary electrophoresis (CE) method has been chosen to separate and quantitate the levels of these anions in final product and in-process intermediate samples. Furthermore, this optimized CE method has been successfully qualified and is routinely used to support vaccine process development.