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A review of advanced small-scale parallel bioreactor technology for accelerated process development: Current state and future need

Authors

  • Rachel Bareither,

    1. Biologics New & Enabling Technologies, Biologics Development, Merck Research Laboratories, Merck & Co. Inc., Rahway, NJ 07065
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  • David Pollard

    Corresponding author
    1. Biologics New & Enabling Technologies, Biologics Development, Merck Research Laboratories, Merck & Co. Inc., Rahway, NJ 07065
    • Biologics New & Enabling Technologies, Biologics Development, Merck Research Laboratories, Merck & Co. Inc., Rahway, NJ 07065
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Abstract

The pharmaceutical and biotech industries face continued pressure to reduce development costs and accelerate process development. This challenge occurs alongside the need for increased upstream experimentation to support quality by design initiatives and the pursuit of predictive models from systems biology. A small scale system enabling multiple reactions in parallel (n ≥ 20), with automated sampling and integrated to purification, would provide significant improvement (four to fivefold) to development timelines. State of the art attempts to pursue high throughput process development include shake flasks, microfluidic reactors, microtiter plates and small-scale stirred reactors. The limitations of these systems are compared to desired criteria to mimic large scale commercial processes. The comparison shows that significant technological improvement is still required to provide automated solutions that can speed upstream process development. © 2010 American Institute of Chemical Engineers Biotechnol. Prog., 2011

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