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Manufacture Biosimilars, Small Molecules

The CHO’s Over: An Inflexion Point

Ever since Genentech’s plasminogen activator, Activase, became the first human therapeutic product made using CHO cells in 1987, the CHO cell line has become a mainstay of the biopharma industry. Indeed, CHO cells are used to make the bestselling monoclonal antibodies (mAbs), including Rituxan, Humira and Enbrel. However, for the next wave of biologics – bi-specific and tri-specific antibodies, for example – CHO’s low expression yields are driving costs beyond commercial viability for many companies. And after more than three decades of CHO cell line improvements, which have seen huge overinvestment, it seems unlikely that any incremental productivity and cost improvements will fundamentally change the game. In my view, we need to look beyond the limitations and costs of CHO – in fact beyond mammalian cell lines altogether. 

Microbial cell lines may be what the industry needs in terms of production costs and speed, as well as product quality. Studies have shown that it takes around twice as long to create CHO cell lines and to prepare cells for the fermenter, when compared with microbial cell lines (1). With regard to creating mAbs, CHO entails a higher capital expenditure and operating expenditure than using microbial cell lines, and larger fermentation vessels are needed with CHO to obtain an equal output of mAbs. In addition to lower yield and longer cycle time, CHO cells require expensive enriched growth media and viral purification steps, neither of which are required with certain microbial cells. In other words, manufacturers can grow microbial cells at a lower cost for a given yield, potentially allowing next-generation biologics to be manufactured in smaller (cheaper) facilities, improving commercial viability.

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About the Author

Mark Emalfarb

Mark Emalfarb is President and Chief Executive Officer, Dyadic International, Jupiter, FL, USA.

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