Continuous bioprocessing offers numerous benefits that have been highlighted recently in literature. While a great deal research has allowed for relevant developments in continuous cell culture processes, downstream challenges, such as continuous viral inactivation, have not been addressed. The purpose of this work is to design a chamber that incubates a continuous product stream at desired incubation time; this time is typically 1hr. Since plug flow cannot be achieved at typical incubation times and flow rates, one of the biggest challenges is to address dispersion of the product stream. Since several viral logs should be removed during a virus removal step, the restriction is that only 1-10ppm of the original product should exit the chamber before the specified time. In this work, an initial design is chosen such that the incubation chamber is easy to handle, has a small footprint, and there are no pressure concerns at the desired flow rates. Pulse response experiments are performed to generate cumulative residence time distribution functions. The average residence time distribution function is used to find the time at which 1/10­<sup>6</sup> of the original tracer concentration passes through the chamber. It is desired to verify by an orthogonal method that the diluted tracer concentration of at the desired time falls under the predicted value. Thus, the starting tracer solution must be concentrated enough such that a concentration of 1/10<sup>6</sup> can be measured by a highly sensitive technique. In this work, a tracer solution and a method of detection were selected. Preliminary results of chamber design will be shown and current challenges will be shared.

Design and characterization of an incubation chamber for continuous viral inactivation

249th National Meeting (2015)

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