Higher density, higher titer cell culture processes have placed an increased burden on the harvest step for both single-use and multi-use facilities.  We will focus on the impact on our single-use facility, which currently leverages the Millistak+ POD disposable depth filtration system for primary and secondary clarification.  This depth filtration harvest process has performed well for numerous campaigns; however, the higher density feed streams require the use of increased filtration area, which leads to significant buffer consumption in order to achieve a closed system within a controlled, non-classified environment.  Over the past several years, numerous technologies have been evaluated to address these challenges, including acoustic wave separation, body feed filtration, enhanced settling with a cationic polymer flocculant, and a second generation depth filtration media, Clarisolve.  We will summarize the development data from these technologies and explore their impact on process economics and buffer consumption, as well as their compatibility with the existing single-use manufacturing suite.

Evaluation of single use harvest technologies

253rd National Meeting (2017)

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