Abstract

in this large scale manufacturing facility were similar to at the academic facility. Leveraging a proven step-wise industry transfer process to capture academic experience along with extensive collaborative training and strong analytics led to this successful CAR cell therapy process transfer from academia to industry. This resulted in comparable CTL019 cell expansion growth curves to those observed from academia. Cell processing for the Phase II trials initiated outside the US, including Europe, Canada and Australia, is carried out at the state-of-the-art global manufacturing facility. (Figure 1)

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