Determination of the chromatography media life for enterovirus 71 inactivated vaccine purification

Objective To determine the optimum number of usages for chromatography media in human enterovirus 71 inactivated vaccine purification. Methods In large-scale production, different cleaning methods were used to clean and disinfect corresponding chromatography media according to media characteristics. On the premise of guaranteeing product quality, the service life of the chromatography media was evaluated based on related parameters and column efficiency. Results With the usage of chromatography media increasing, the pressure of media was rising during purification process, indicating the accumulation of pollutants. Meanwhile, column theoretical plate number per meter decreased and the symmetry factor deviated.The uneven packing distribution caused by accumulation of contaminants in media resulted in decrease of separation efficiency. Through comprehensive evaluation, the usage numbers of gel filtration and ion-exchange chromatography media in large-scale production were determined as 62 and 32, respectively. Conclusion The service life of chromatography media has been preliminarily determined, providing theoretical basis for the use and replacement of chromatography media in large-scale production. Key words: Enterovirus 71 inactivated vaccine; Chromatography media; Service life