期刊论文 Managing cell line instability and its impact during cell line development复制

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M Leonard, M Hone, C Cooley, K Mccarthy, K Crowe…
2009
biopharminternational.com
For a Phase 1 antibody project, the primary objective of our cell line development group is to deliver a stable, high performing, clonal cell line in an aggressive timeframe, leaving little time to react to the challenges associated with cell line instability, such as dramatically reduced product expression. Our current cell line development timeline allows for 6.5 months from transfection to the establishment of a cell bank for a lead clone, which is expected to deliver 1–3 g/L in a fed-batch process. Our cell line selection process consists of …