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Descriptive Statistics And Trends Of Process Parameters

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4.4. Descriptive Statistics and Trends of Process Parameters
Mean, standard deviation, CV, maximum and minimum values of process parameters from the 10 batches studied are shown in table 6 (see page 14 -15).
The variability (CV) of the studied process parameters ranged from 1.2% -108.3%. Buffer analyte chemistry and charcoal mixing duration had CV less than 3 % (Range 1.2% -2.6%) and showed very little variation. The starting volume, volume post diafiltration and final volume post aseptic filtration had CV ranges from 9.6%-11.1 % indicating that the variability of plasma volume at three important stages of the process was not high. Process parameters during diafiltration such as volumetric concentration factor (VCF), membrane protein loading, process flux and number of buffer exchanges had CV values between 11.6 % and 21.1 %. The throughput (volume filtered per filter) for all filter types (M10, M90, Keystone, bag filters and 0.2 µm filters) exhibited variability (CV) in the range of 24.9 % to 47.8 %. Freeze duration post Aresoil addition, freeze duration post Aerosil removal and mix duration post Aerosil addition, all three factors involved with the delipidation showed variability greater than 30% (range 30.7%-108.3 %).
The in-process parameters were analyzed for trends by plotting time series graph (see page 22 -25) there was no significant trends in most of the parameters studied except for starting plasma volume, which showed a gradual increasing pattern over

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