Platform production processes are commonly used in monoclonal antibody production to speed investigational products to the clinic. A similar approach was used to establish a live virus vaccine production platform using rVSV constructs. The first candidate was acquired through a collaborative agreement and was taken from a small scale phase I process to commercial scale in approximately six months. Two GMP drug substance batches were produced in three months post development. In parallel, two other live virus vaccine candidates were taken from concept to clinical supply in eight months. Overall, in less than 15 months, three live virus vaccine candidates were progressed from scope definition through GMP drug product manufacture. This presentation will discuss the different activities that took place in the development space to enable definition of a downstream single use process platform which was then implemented to produce three different rVSV vaccine candidates. Two front runs were performed for each vaccine candidate and results for each unit operation were compared to the performance of the original process. Key quality attributes were evaluated, ensuring release specifications would be met. These proof of platform studies enabled the go to clinical production decision to be made after two months of process development. As part of this talk, implementation of a fully single use sterile flow path will be reviewed. Also, some of the key issues encountered as part of the transfer and scale-up from a CMO to the West Point Biologics Pilot Plant will be discussed.

Development, scale-up and proof of concept of a live virus vaccine platform using single use technology in the clinical space

253rd National Meeting (2017)

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