When downstream process is able to withstand upstream changes! An example of clarification sequence optimization in viral vaccine production

While improving cell growth and viral productivity in USP, DSP may become the production bottleneck if not able to withstand changes.

Such a case appears when optimizing cell culture media during the development of a viral vaccine candidate. Thirty percent expression increased was balanced by twenty percent yield loss and filters clogging during the clarification step. As a consequence, clarification sequence was not scalable anymore for the further manufacturing.

The poster describes sanofi pasteur approach to overcome this issue and how a new clarification train was found that meet industrial requirements in terms of filter sizing and performance (without affecting Drug substance CQA).

Due to the many different types of filters existing, choosing the best filter sequence was a challenge and successful solution is presented.