There is strong industry-wide acceptance of the general QbD approach to process validation; tying manufacturing process parameters to patient outcomes.  However, many implementation details are still being worked out.  This talk proposes a vendor approach to assisting biopharmaceutical manufacturers with their QbD filing using the Viresolve® Pro filter.  It describes an approach to parameters selection, a knowledge base containing data and analysis support a size exclusion mechanism of operation.  An example is shown how this knowledge base can be used with a risk analysis to inform virus spiking studies to define a Viresolve® Pro design space and to define a Viresolve® Pro process control strategy.

Virus filtration QbD knowledge base

249th National Meeting (2015)

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