S120: Use of a design space approach to characterize a depth filtration bioprocess step

In an effort to improve the efficiency of process characterization, the design space approach was used to plan and execute characterization experiments for the depth filtration bioprocess step of a late phase biopharmaceutical product.  A risk assessment of all parameters involved in the depth filtration bioprocess step was performed.  Four upstream process parameters were identified as potentially impacting the depth filtration bioprocess step:  stir rate, temperature, overlay rate, and vessel pressure.  Using design of experiments (DoE), the impact of the four principle process parameters on the depth filtration bioprocess step were determined.  While the process operating parameters had minimal impact on biopharmaceutical product formation, the agitation rate did have a significant effect on the average filter flux of the fermentation broth during the filtration unit operation.  The outcome of this study demonstrates that the design space approach is an efficient and effective method for the characterization of a bioprocess step.