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Published in 2018 at "Biotechnology Progress"
DOI: 10.1002/btpr.2666
Abstract: Regulatory guidelines require the sponsors to provide assurance of clonality of the production cell line, and when such evidence is not available, additional studies are typically required to further ensure consistent longāterm manufacturing of the…
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Keywords:
cell line;
derived clonal;
diversity;
phenotypic genotypic ... See more keywords