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Worst-case protein concentration for degradation study for cleaning

Discussion in 'Manufacturing and Related Processes' started by Sunny, Jan 9, 2018.

  1. Sunny

    Sunny New Member

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    Hi all, I'm new here so this is my very first thread! I'm in the process of setting up a degradation study for a cleaning process and I'm a bit stuck with how to determine the worst-case protein concentration for my bench scale study that represents the actual process. Say I have several chromatography steps and a last filtration step before the product is in it's 'final', then I would take the equipment used for final filtration which I know the protein concentration going in. When cleaning it will have several rinses before the actual cleaning agent, how do I determine the concentration of protein to work with for my bench scale with the cleaning agent? Any suggestions welcome. Thank you!
     

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