When they do the Tox studies they have to use what they have produced in the engineering run which is designed to be used for human clinical trials...
They cant use what they originally done even though they had some fermentation in that test because that process was not up to scratch to go to trials with...
They have to use what they are going to trials with for the Tox study..
Ann: Stable Cell Line for Production of PAT-DX3 Established, page-37
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