Articles
Cell Line Engineering Methods For Improving Productivity
April 17, 2009
Article: Cell Line Engineering Methods For Improving Productivity
By Kevin Kayser, Nan Lin, Dan Allison, Laurie Donahue, and Matt Caple
Monoclonal antibodies (MAb) and nonantibody recombinant proteins (r-proteins) currently produced in biopharmaceutical manufacturing processes are most often expressed in cultivated mammalian cell lines. Chinese hamster ovary (CHO) cells remain the most prominent mammalian cell line used in such manufacturing processes, but several other cell lines derived from mouse, baby hamster, and human sources have recently gained industry acceptance and regulatory approval. Therapeutic protein and MAb manufacturing processes continue to suffer from variable and unstable expression in mammalian cell lines that often results in low product yield (low productivity). Because of unpredictable stability and productivity issues in therapeutic protein production, manufacturing costs can be very high in comparison with costs associated with conventional small-molecule drug production efforts. To lower both cost and risk, most therapeutic protein production programs now include cellline engineering strategies to enhance efforts toward the ultimate production of stable and high-yield cGMP cell banks. Here we review some of the current strategies used in academic and industrial laboratories to achieve stable and highly productive (r-proteins and MAb yield) mammalian cell lines.
Reprinted with permission from BioProcess International 4(5):S6-S13 (May 2006)
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