The present set of embodiments relate to a bioproduction system, method, and apparatus for creating a scalable bioreactor system. Specifically, the present set of embodiments enable the determination of bioreaction performance characteristics of a commercial scale by matching operational parameters between a small test scale bioreaction to that of a commercial scale bioreaction. The system and methods do not rely on simply making bioreactor apparatuses across scales the same dimensionally which would not account for differences in fluid dynamic properties between very small to very large volumes, but requires tuning of a variety of systems (mixing assembly, sparger system, and headspace airflow system) in conjunction with one another to achieve predictive outcomes.

A method of mixing a fluid includes at least partially unfolding a collapsible bag bounding a compartment, the collapsible bag containing in the compartment at least a portion of an elongated drive line or drive shaft and an impeller secured to the drive line or drive shaft, the impeller including a plurality of impeller blades that are pivotable relative to the drive line or drive shaft, at least one of the plurality of impeller blades being in a collapsed position. A fluid is delivered into the compartment of the collapsible bag. The drive line or drive shaft is then rotated so as to rotate the impeller within the compartment and mix the fluid therein, the at least one of the plurality of impeller blades pivoting from the collapsed position to an expanded position as the impeller is rotated within the compartment.

The present set of embodiments relate to a bioproduction system, method, and apparatus for creating a scalable bioreactor system. Specifically, the present set of embodiments enable the determination of bioreaction performance characteristics of a commercial scale by matching operational parameters between a small test scale bioreaction to that of a commercial scale bioreaction. The system and methods do not rely on simply making bioreactor apparatuses across scales the same dimensionally which would not account for differences in fluid dynamic properties between very small to very large volumes, but requires tuning of a variety of systems (mixing assembly, sparger system, and headspace airflow system) in conjunction with one another to achieve predictive outcomes.

Apparatus and methods for a mixing device are presented. The mixing device comprises a shaft and a plurality of blades attached to the shaft. The blades include a variable pitch angle configured to create axial fluid flow and radial fluid flow within a container. The apparatus includes a hub and a cage located at ends of the apparatus. The cage includes an open end configured to mate with a structure attached to the container. In further examples of the apparatus, the upper blade is configured to create axial flow in a substantially downward direction. The lower blade is configured to create axial flow in a substantially upward direction. The lower blade can create an axial flow that encounters the upper blade. A method includes locating a mixing apparatus within the container, inserting fluid within the container, rotating the mixing apparatus, and mixing the fluid.

A fluid transfer assembly for single use bioreactors includes a fluid transfer housing that can be mounted to the impeller shaft using a bearing that places the fluid transfer assembly directly below the lowest impeller but allows the impeller shaft to spin inside independently of the fluid transfer assembly. A fluid conduit connects the fluid transfer housing to a port in the single use bag wall which allows fluids to be introduced into the sparger and which also helps prevent the fluid transfer assembly from rotating with the impeller shaft.

A fluid mixing system includes a container, such as a flexible bag, bounding a compartment. A flexible drive line is disposed within the compartment, the drive line having a first end rotatably connected to a first end of the container and an opposing second end rotatably connected to a second end of the container. At least one mixing element, such as an impeller, is coupled with the flexible drive line. Rotation of the drive line facilitates rotation of the impeller within the container.

The stirring device, in particular for a fluid-mixing bioreactor, comprises a drive shaft including a rod, an agitating element and a sleeve of tubular shape. The sleeve forms a coupling sleeve receiving the shaft therethrough and is directly rotationally coupled to the rod. The agitating element, which has a hub with an annular side wall delimiting an inner space and an impeller assembly comprising blades, is indirectly rotationally coupled to the rod via the sleeve that is engaged in the inner space. One of an inner surface of the wall and an outer surface of the sleeve is a guiding surface with progressively reduced cross section. Axial movement between the hub and the sleeve is prevented in a locked configuration of a sleeve fastening arrangement. Hub-sleeve contact areas can be axially distributed.

A container for fermenting bio-degradable substances, the container comprising: a base and a wall, wherein an interior of the container is enclosed by the base and the wall; a rotatable agitator that protrudes into the interior and is supported in an upper bearing and a lower bearing in an installed position of the rotatable agitator in the container, wherein the rotatable agitator includes a shaft that is drivable by a drive, wherein at least one stirring paddle is arranged at the shaft and configured to co-rotate with the shaft so that substances arranged in the container are stirrable, wherein the lower bearing is arranged at the at least one base of the container and a bearing device located at a lower end of the shaft is supported in the lower bearing in the installed position of the rotatable agitator.

A bioproduction mixing system includes a flexible compartment having a first end, a second end, and a sidewall extending therebetween, a center axis passing through the flexible compartment between the first end and the second end. A helical assembly is disposed within the flexible compartment and is suspended between the first end and the second end, the helical assembly being offset from the center axis of the flexible compartment.

A method of installing a flexible bioprocess container in a bioprocessing system having a rigid housing with an interior compartment and extending between a top and an opposing base. The method includes coupling a first surface of the flexible bioprocess container to a moveable platform positioned within the interior compartment of the rigid housing; coupling a second surface of the flexible bioprocess container to the base of the rigid housing; and moving the movable platform relative to the rigid housing and toward the top of the rigid housing so as to at least partially expand the flexible bioprocess container within the interior compartment of the rigid housing.