Downscaling in Human Cell Culture: Capabilities of Small Scale Single-Use Bioreactors
- Fig. 1: A 4-fold Dasbox Mini Bioreactor System with Dasbox single-use vessels
- Fig. 2: Viable cell numbers of all experiments with Dasgip PBS and Dasbox SU vessels with average growth rate of 0.02 h-1.
- Fig. 3: Comparison of metabolic activity by glucose consumption.
- Fig. 4: Product yield normalized to the average protein concentration gained using the PBS.
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In biopharmaceutical applications downscaling of proven processes is a crucial issue while single use technologies gain more and more importance. The following article gives insight to evaluation procedures of a novel, fully instrumented small scale single-use bioreactor.
Increasing process complexity coupled with rising cost pressures and rapidly evolving regulatory requirements makes today's process development efforts a special challenge. The pressure of achieving faster time-to-market for new and innovative biotechnological products has led to the need to optimize every element of the total development workflow. Initial bioprocess development involves cell line optimization, clone selection, and screening for media, feed components and strategies, and other process conditions. Shake flasks, the most common vessels used in early cell and microorganism work, have served the biotechnology industry well over the decades but their limitations for optimizing cell culture or fermentation conditions are well known. Equipment used during screening should mimic the physical and mechanical characteristics of production-scale bioreactors to the greatest degree possible in order to assure, consistency throughout development phases. Ideally, these best practices will support the aims of QbD: that quality measures initiated during development are carried forward and manifested in product quality.