Performing Quality by Design on hydrolysates: a DOE case study

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Hydrolysates provide increased cell growth and titers. The aim of FrieslandCampina Domo is to re-define hydrolysates and re-design their quality profile. The Quality by Design concept as put forward by the FDA proves to be an excellent framework for achieving these goals. In addition it will also enable FrieslandCampina Domo to provide a Design Space of this critical raw material for the biopharmaceutical industry and so making process changes easier and cost effective.

FrieslandCampina Domo has analysed protein hydrolysates at the individual component level and correlated this with cell culture performance. By adding process data we identified the priority of the DOE experiments. While the correlations pointed strongly to a number of steps in the process, the DOE experiments showed these steps to be very robust. This surprise finding underlines the importance of considering how the various steps of a process are

linked (see for example p. 171 of the A-Mab case study, Oct. 2009, CMC working group) and shows the possibility of how variability may not appear at its source.