Production of live virus vaccine candidates too large for sterile filtration is particularly challenging, as the entire process must be performed using aseptic technique.  For a candidate requiring extensive purification, downstream unit operations that are typically not performed under sterile conditions must be adapted to the sterile processing environment.  Development of such a process for an enveloped live virus will be presented in which membrane chromatography and sterilizable TFF technology are used as the basis of an aseptic purification process.  To achieve maximum purification, chromatography modalities not currently available in membrane form were also evaluated, and strategies for incorporation of bead-based chromatography into a sterile process are discussed. <br/>

Downstream processing of a large live virus: Challenges in developing a sterile purification process

249th National Meeting (2015)

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