In the last decade, the development of single-use technologies in biopharmaceutical manufacturing has brought a wide variety of bioreactor systems from 10 mL up to 2,000 L to the market.
The use of single-use bags in an orbital incubator shaker represents a novel and very simple approach for the scale-up of processes to a working volume of 10 L. This has been realized by INFORS HT through the introduction of the ShakerBag Option for Multitron Cell shaker incubators.
A detailed study provided an initial engineering characterization of orbitally shaken single-use bags with a square footprint using traditional methods. The results were compared with geometrically dissimilar tubular bioreactors and conical cultivation vessels (e.g., tubes, shake flasks).
Additionally, computational fluid dynamics (CFD) was used to gain a deeper insight and increase knowledge of fluid flow behavior. The use of CFD offers the advantage of being able to obtain local and time dependent results, allowing analysis of minimal and maximal values for process crucial parameters, which cannot be evaluated using traditional methods.
The results of the engineering characterization were validated by cultivating plant suspension cultures (Nicotiana tabacum BY-2 and Vitis vinifera) and insect Sf9 cell cultures. These cell cultures can be used for the production of bioactive substances such as secondary metabolites (plant cells), vaccines (insect cells) and recombinant proteins (plant and animal cells) having importance in pharmacy and cosmetics.
Thus, the option to easily scale up processes using orbitally shaken bags shows great promise and creates potential for rapid, cost-saving increases in cultivation volumes using existing shaking incubators.