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Miniature bioreactors add value by reducing validation efforts.
Better process understanding has the potential to reduce cost, and this is increasingly being achieved through the use of miniature and microbioreactor systems. Christel Fenge, vice-president of marketing and product management, fermentation technology, Sartorius Stedim Biotech says the miniature systems and their corresponding single-use vessels “more precisely mimic larger-scale bioreactors” in terms of stirring, gas, and pH control. Citing work by Lewis et al. (1), Fenge comments that “these systems more accurately predict cell-line productivity at larger scale, ensuring that high-productivity cell lines (that also work at scale) are selected at an early stage.” Multiparallel systems that incorporate automated feeding and sampling have also driven process efficiencies and allowed for speedier clone selection and initial parameter selection, Fenge adds. “In combination, these micro- and mini-bioreactor systems provide efficiency gains as a result of automated high-throughput cell line, media, and process development that can enable a faster throughput of pipeline projects and allow larger experiment designs, leading to a wider process understanding.”
Process efficiencies equal cost savings, says Cobra Biologics’ Technical Director Tony Hitchcock, as reduced development times, improved productivity, and enhanced characterization time allow products to be brought to clinical stages and the market more quickly. Scott Waniger, vice-president of bioservices at the Cell Culture Company stresses that cost-savings also come in the form of a decrease in validation efforts. “As long as the miniature bioreactors are scalable, the savings obtained from reduced validation as the process scales up are drastically high,” Waniger notes. “Using a system in which the cell-occupied space does not change in form, fit, and function-and can be scaled up with the insertion of more cell spaces in a parallel manner-helps generate data that can be directly extrapolated from small to large scale and prevents costly and time-consuming revalidation at each step.”
1. G. Lewis et al., Bioprocess J. 9 (1), pp. 22–25 (2010).
Article DetailsBioPharm International
Vol. 29, No. 3
Citation: When referring to this article, please cite it as R. Hernandez, "Miniature Bioreactors for Improved Process Understanding," BioPharm International29 (3) 2016.