Differential response in downstream processing of CHO cells grown under mild hypothermic conditions.

24 The higher peak and harvest viable cell counts and extended culture period associated with the culture grown under mild hypothermic conditions are therefore likely to be significant contributing factors accounting for this difference.

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Although the proteomic methods used in this work suffer from some limitations, as discussed in further detail in Tarrant et al., 26 any differences in the impurity profile, even if minor, may be significant as these are one of the primary impurities targeted for removal during the purification process. 33 This also provides rationale for further examination of HCPs, when changes to the existing production process are made, in particular on whether or not there is a consequence on the effectiveness of the purification process.

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