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Assessment of the biochemical characteristics of Rotavirus; implications for process development

By R.M.F. van der Put


Rotavirus was first discovered in 1973, and is a major cause of acute gastroenteritis both in children in developing and developed countries. On a global scale, episodes of rotavirus diarrheal disease occurring in infants under the age of five are estimated to affect over 100 million individuals. Therefore, it is important to develop a safe and effective rotavirus vaccine for use in humans. This literature review evaluates the status and challenges of rotavirus vaccine development, with the goal to use the current in-house Polio production process as a platform. Different types of rotaviruses are propagated on a wide array of different cell substrates, all with their own specificities and efficiency. Purification of rotavirus has historically been performed using gradient centrifugation. Nevertheless, more recent other more easy, and scalable, procedures have been described. Here, the use of filtration and buffer exchange are good examples. In addition, introduction of ion exchange to capture the virus or the impurities have found their way to rotavirus purification. Now, when evaluating the upstream Polio production process, it can be concluded that propagation of the human rotavirus using Vero cells will be possible. Nevertheless, the implementation of virus activation and virus adsorption will have to be investigated, because these do not apply to the current production process for Polio. Similar conditions apply to the downstream process. The different size of the virus will have to investigated for efficiency in size exclusion chromatography. Adding to this, the isoelectric point of the human rotavirus will have to be determined in order to make a correct estimate on the behavior in the ion exchange chromatography process step. Based on the findings in current literature, the Polio production process, as performed at Intravacc, can likely act as a platform for the production of the human rotavirus. The upstream process will have to be evaluated for maximum virus yield, and the introduction of virus activation and adsorption. The downstream process will have to be closely investigated for performance. Here, purity is not to be compromised because the final vaccine will be injected parentally, with the required purity levels being critical

Topics: Rotavirus, Production, Process development, Upstream processing, Downstreamprocessing
Year: 2013
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