Biopharmaceutical plant in a column

Abstract

The present invention relates to a series of therapeutic material processing devices stacked into a column, hereby creating a bio material process plant with extremely small foot-print and all the processing devices being of single-use capabilities for lowest possible cost and methods of operating said column.

Description

TECHNICAL FIELD[0001]The present invention relates to a set of therapeutic material multifunctional processing highly flexible devices stacked in a column, hereby creating a process plant with extremely small foot-print and where preferably all processing devices are of single-use capabilities in order to obtain lowest possible costs. The present invention also relates to methods for continued operation of said bioreactor.BACKGROUND OF THE INVENTION[0002]Disposable bioreactors were considered a novelty, and perhaps even a passing trend, as recently as mid 90ties. As single-use bioreactors and filters have matured and begun to address most of these issues, their market acceptance has rapidly expanded. The development of disposable bioreactors and filters is, in many instances, driven by reduction in sterilisation and cleaning requirements, improved plant flexibility, reduced costs and faster time to market for the end product. Recently, all of these benefits have been well documented...

AI Technical Summary

Benefits of technology

[0020]The present invention solves the problem of how to improve the flexibility of a bioreactor by providing a number of capsules serving different purposes for the bio-reaction taken place in the bioreactor. The capsules are easily assembled in a stack. By selecting a particular combination of different capsules stacked in a predetermined sequence, a bioreactor providing the optimal solution for producing a particular chemical compound is easily developed.

[0021]The present invention also solves the problem of how to optimize the size of the bioreactor by providing a reactor with increased “compactness”, which reduces the cost of manufacturing production facilities needed for industrial scale bio-fermentation.

[0029]The above six groups each allow for many variations of performance and technical art though all being preferably of disposable character, which eliminates the costly CIP, SIP processes and the associated validation procedure. The stack of the present invention, which includes high cell density bioreactor capsules, further reduces the size requirements to the white room facilities. Operation mode based on the bio factory according to the present invention and its capsules integrated therein offers quite extraordinary possibilities, which so far are unknown in the industry.

[0037]In one embodiment at least one of the conditioning capsule(s) is a combined diffusion and pH-regulating capsule, i.e. both supply of oxygen and regulation of pH takes place in the same capsule. This combination may be beneficial in cases where pH is regulated by supplying gases such as for example CO2 to the liquid media flowing through the reactor. The incorporation of two functions into one capsule also improves the compactness of the reactor. Typically the number of combined diffusion and pH-regulating capsules lies in the range of 1 to 20, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20.

Problems solved by technology

There is no such thing available on the market or described in the patent literature, as disposable bioreactors or disposable fluid pumps, sensors, heating, conditioning, sparging devices, oxygenating devices integrated into capsules for stacking purposes into a bio factory.

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