Patent Description:
A variety of vessels, devices, components and unit operations are known for carrying out biochemical and/or biological processes and/or manipulating liquids and other products of such processes. In order to avoid the time, expense, and difficulties associated with sterilizing the vessels used in biopharmaceutical manufacturing processes, single-use or disposable bioreactor bags and single-use mixer bags are used as such vessels. For instance, biological materials (e.g., animal and plant cells) including, for example, mammalian, plant or insect cells and microbial cultures can be processed using disposable or single-use mixers and bioreactors.

Increasingly, in the biopharmaceutical industry, single use or disposable containers are used. Such containers can be flexible or collapsible plastic bags that are supported by an outer rigid structure such as a stainless steel shell or vessel. See, for example, <CIT> and <CIT>. Use of sterilized disposable bags eliminates time-consuming step of cleaning of the vessel and reduces the chance of contamination. The bag may be positioned within the rigid vessel and filled with the desired fluid for mixing. Depending on the fluid being processed, the system may include a number of fluid lines and different sensors, probes and ports coupled with the bag for monitoring, analytics, sampling, and fluid transfer. For example, a plurality of ports may typically be located at the front of the bag and accessible through an opening in the sidewall of the vessel, which provide connection points for sensors, probes and/or fluid sampling lines. In addition, a harvest port or drain line fitting is typically located at the bottom of the disposable bag and is configured for insertion through an opening in the bottom of the vessel, allowing for a harvest line to be connected to the bag for harvesting and draining of the bag after the bioprocess is complete.

Typically, an agitator assembly disposed within the bag is used to mix the fluid. Existing agitators are either top-driven (having a shaft that extends downwardly into the bag, on which one or more impellers are mounted) or bottom-driven (having an impeller disposed in the bottom of the bag that is driven by a magnetic drive system or motor positioned outside the bag and/or vessel). Most magnetic agitator systems include a rotating magnetic drive head outside of the bag and a rotating magnetic agitator (also referred to in this context as the "impeller") within the bag. The movement of the magnetic drive head enables torque transfer and thus rotation of the magnetic agitator allowing the agitator to mix a fluid within the vessel. Magnetic coupling of the agitator inside the bag, to a drive system or motor external to the bag and/or bioreactor vessel, can eliminate contamination issues, allow for a completely enclosed system, and prevent leakage. Because there is no need to have a drive shaft penetrate the bioreactor vessel wall to mechanically spin the agitator, magnetically coupled systems can also eliminate the need for having seals between the drive shaft and the vessel.

Installation and setup of the flexible bioprocessing bag within the bioreactor vessel, along with the associated tubing, filter heaters, impeller and other components can be a labor intensive and time-consuming process. For example, existing bioreactor vessels may present accessibility issues, making it difficult to align and properly seat the impeller with the bioreactor vessel base. Multiple operators and ladders may also be needed, especially for the installation of tubing and filter heaters, which are located at the top of the vessel. Moreover, lack of tubing support for the various tubes connected to the flexible bag can lead to a cluttered array of tubes around the bioreactor vessel. In addition to the above, with existing systems, inflation and deflation of the flexible bioprocessing bag consumable can also a time-consuming process, taking between <NUM> minutes and almost an hour.

In addition to difficulties installing the flexible bioprocessing bag and other components at the top of the bioreactor vessel, properly seating the impeller base plate of the flexible bioprocessing bag on the bottom of the bioreactor vessel during installation of the flexible bag may also present challenges. In particular, with existing systems, there is no feedback mechanism, other than visual inspection, to indicate that the impeller base plate of the flexible bag is properly seated within the recess in the bottom of the bioreactor vessel. Even when a visual inspection reveals that the base plate is properly seated, movement of the base plate before mating of the agitator and magnetic drive assembly beneath the vessel is possible.

In view of the above, there is a need for a system for a bioprocessing system that is ergonomically efficient, facilitates installation and setup, and/or assists in the inflation and deflation of the flexible bioprocessing bag.

Various aspects and embodiments of the present invention are defined by the appended claims.

Reference will be made below in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference characters used throughout the drawings refer to the same or like parts.

As used herein, the term "flexible" or "collapsible" refers to a structure or material that is pliable, or capable of being bent without breaking, and may also refer to a material that is compressible or expandable. An example of a flexible structure is a bag formed of polyethylene film. The terms "rigid" and "semi-rigid" are used herein interchangeably to describe structures that are "non-collapsible," that is to say structures that do not fold, collapse, or otherwise deform under normal forces to substantially reduce their elongate dimension. Depending on the context, "semi-rigid" can also denote a structure that is more flexible than a "rigid" element, e.g., a bendable tube or conduit, but still one that does not collapse longitudinally under normal conditions and forces.

A "vessel," as the term is used herein, means a flexible bag, a flexible container, a semi-rigid container, a rigid container, or a flexible or semi-rigid tubing, as the case may be. The term "vessel" as used herein is intended to encompass bioreactor vessels having a wall or a portion of a wall that is flexible or semi-rigid, single use flexible bags, as well as other containers or conduits commonly used in biological or biochemical processing, including, for example, cell culture/purification systems, mixing systems, media/buffer preparation systems, and filtration/purification systems, e.g., chromatography and tangential flow filter systems, and their associated flow paths. As used herein, the term "bag" means a flexible or semi-rigid container or vessel used, for example, as a bioreactor or mixer for the contents within. As used herein, "consumable" or "consumable component" means devices or components that are intended to be replaced regularly due to wear or use.

Embodiments of the invention provide bioprocessing systems. In an embodiment, a bioreactor vessel includes a bottom, a peripheral sidewall, the bottom and the peripheral sidewall defining an interior space for receiving a flexible bioprocessing bag, a recess in the bottom for receiving a base plate of the flexible bioprocessing bag, and a locking mechanism configured to retain the base plate in the recess.

Further embodiments of the disclosure provide bioprocessing systems and, in particular, tubing and components management systems and devices for a bioreactor system. In an embodiment, a bioreactor vessel includes a bottom, a peripheral sidewall, the bottom and the peripheral sidewall defining an interior space for receiving a flexible bioprocessing bag, a recess in the bottom for receiving a base plate of the flexible bioprocessing bag, a locking mechanism configured to retain the base plate in the recess, and an indicator mechanism configured to indicate when the base plate is properly positioned within the recess.

Embodiments of the disclosure provide bioprocessing systems and, in particular, tubing and components management systems and devices for a bioreactor system. In an embodiment, a bioprocessing system includes a vessel defining an interior space for receiving a flexible bioprocessing bag, the vessel having an access door in a sidewall of the vessel and providing access to the interior space, and a tubing and component management apparatus mounted to the sidewall of the vessel and having a mounting frame for mounting of at least one consumable component of the bioprocessing system. The mounting frame is moveable vertically into and out of the interior space.

With reference to <FIG>, a bioreactor system <NUM> according to an embodiment of the disclosure is illustrated. The bioreactor system <NUM> includes a generally rigid bioreactor vessel or support structure <NUM> mounted atop a base <NUM> having a plurality of legs <NUM>. The vessel <NUM> may be formed, for example, from stainless steel, polymers, composites, glass, or other metals, and may be cylindrical in shape, although other shapes may also be utilized without departing from the broader aspects of the invention. The vessel <NUM> can be any shape or size as long as it is capable of supporting a single-use, flexible bioreactor bag in an interior space <NUM> thereof. For example, according to one embodiment of the invention the vessel <NUM> is capable of accepting and supporting a <NUM>-<NUM> flexible or collapsible bioprocess bag.

The vessel <NUM> may include one or more sight windows <NUM>, which allows an operator to view a fluid level within the flexible bag positioned within the interior space <NUM>, as well as a window <NUM> positioned at a lower area of the vessel <NUM>. The window <NUM> allows access to the interior of the vessel <NUM> for insertion and positioning of various sensors and probes (not shown) within the flexible bag, and for connecting one or more fluid lines to the flexible bag for fluids, gases, and the like, to be added or withdrawn from the flexible bag. Sensors/probes and controls for monitoring and controlling important process parameters include any one or more, and combinations of: temperature, pressure, pH, dissolved oxygen (DO), dissolved carbon dioxide (pCO<NUM>), mixing rate, and gas flow rate, for example.

As best shown in <FIG> and <FIG>, in an embodiment, the vessel <NUM> includes an access door <NUM> hingedly or pivotally connected to a sidewall of the vessel <NUM> and moveable between a closed position (<FIG>) and an open or access position (<FIG>) permitting access to the interior space <NUM>. The door <NUM> may include a handle <NUM> that facilitates movement of the door between the open and closed positions. In an embodiment, the door <NUM> may be configured and positioned such that when the door <NUM> is in the closed position, a lower edge of the door <NUM> forms an upper edge or boundary of the window <NUM>, and/or a side edge of the door <NUM> forms an edge or boundary of the window <NUM>. By having the edges of the door <NUM> define one or more boundaries of the windows <NUM>, <NUM>, when the door <NUM> is in the open position, a contiguous and unobstructed access opening in the sidewall of the vessel is formed by the opening <NUM>, opening <NUM> and open door <NUM> (i.e., the opening in which the door is received). Accordingly, the area of the contiguous access opening formed in the sidewall of the vessel <NUM> when the door is in the open position is equivalent to the combined areas of the door <NUM>, window <NUM> and window <NUM>. This provides greater clearance and access to the interior space <NUM> than would otherwise be possible if the door and windows were separated by a portion of the sidewall of the vessel <NUM>.

With further reference to <FIG>, the interior sidewall of the vessel <NUM> may include one or more vertical baffles <NUM> that project into the interior space <NUM>. The baffles <NUM> may be generally triangular in cross-section, although shapes and configurations known in the art may also be utilized without departing from the broader aspects of the invention. The baffles <NUM> are configured to contact and bias the flexible bag (when installed in the interior space <NUM>) inwardly during a bioprocessing operation, for purposes known in the art. A bottom of the bioreactor vessel <NUM> includes a locating recess <NUM> for receiving an impeller base plate, as discussed in detail hereinafter.

As further shown in <FIG>, the bioreactor system <NUM> also includes a tubing and component management apparatus <NUM>. The apparatus <NUM> includes a support member <NUM> mounted to the exterior sidewall of the vessel <NUM> and extending generally vertically above a top edge of the vessel <NUM>. In an embodiment, the support member <NUM> may be mounted to the vessel by way of welding, bolts, screws, clamps or the like, although other means of attachment may also be utilized without departing from broader aspects of the invention. The apparatus <NUM> further includes a mast arm or boom <NUM> that extends generally horizontally from a distal end of the support member <NUM> and over the vessel <NUM>, a guide sleeve <NUM> depending downwardly from a distal end of the boom <NUM>, and a mounting plate <NUM> having a shaft <NUM> that is slidably received within the guide sleeve <NUM>. In an embodiment, the apparatus <NUM> is configured such that the guide sleeve <NUM> and the shaft <NUM> of the mounting plate <NUM> are aligned with, i.e., coaxial with, a central axis or centerline of the vessel <NUM>.

As best shown in <FIG>, the apparatus <NUM> also includes a lifting mechanism <NUM> that is operable to selectively raise and lower the mounting plate <NUM> within the vessel <NUM>, as in the directions indicated by arrow, A. For example, in an embodiment, the lifting mechanism may include a cable <NUM> connected to the shaft <NUM> of the mounting plate <NUM>, and which extends through the guide sleeve <NUM>, along (or within) the boom <NUM>, and downward along (or within) the support member <NUM>. A distal end of the cable is connected to an actuator which may be, for example, a hand crank, motor or other driving member. The actuator is operable to selectively retract the cable <NUM>, thereby raising the mounting plate <NUM>, or let out the cable <NUM>, thereby lowering the mounting plate <NUM> into the vessel <NUM>.

As illustrated in <FIG>, the mounting plate <NUM> may be generally T-shaped and includes a substantially planar upper surface for the mounting of various components used in bioprocessing operations, such as filters, filter heaters and other consumables. The mounting plate <NUM> may also include an array of slots or apertures configured to receive and retain various tubes configured for connection to the flexible bag received within the vessel <NUM>. One or more hooks <NUM> (or other suitable coupling members) attached to the mounting plate <NUM> may be utilized to move and/or support the flexible bag.

In use, when installing a flexible bioprocessing bag prior to bioprocessing, the access door <NUM> in the sidewall of the vessel <NUM> may be opened, allowing for unobstructed access to the interior space <NUM> within the vessel <NUM>. The lifting mechanism <NUM> may then be utilized to lower the mounting plate <NUM> into the vessel <NUM> to a height where it is easily accessible to an operator (for example, to about waist-height). At this point, the flexible bioprocessing bag (not shown) can be placed inside the vessel <NUM> and attached to the hooks <NUM> of the mounting plate <NUM>. In addition, various tubes connected to the bag (or to be connected to the bag) can be organized and held out of the way of an operator by routing them through the slots/apertures in the mounting plate <NUM>. Moreover, various functional components such as filter heaters, filters and other consumables can be attached to the mounting plate <NUM> such as by bolts. At this point, the actuator of the lifting mechanism <NUM> may be utilized to raise the mounting plate <NUM> to an operational position generally at the top of, or above, the vessel <NUM>. The access door <NUM> can then be moved to a closed position and a bioprocessing operation commenced.

In an embodiment, the lifting mechanism <NUM> may interface with the control unit of the bioreactor system <NUM>, such that upon selecting a 'start' or 'inflate' routine, the lifting mechanism <NUM> will automatically raise the mounting plate <NUM> to an operational position at the top of/above the vessel <NUM>. The position of the mounting plate <NUM> can also serve as a position stop, limiting the extent to which the bag may be inflated. Similarly, at the end of a bioprocessing operation, selecting a 'deflate' or 'end' routine may automatically control the lifting mechanism <NUM> to lower the mounting plate <NUM>. It is envisioned that, in some embodiments, lowering the mounting plate <NUM> may assist with deflation of the flexible bioprocessing bag, which has heretofore been a fairly time-consuming process. For example, lowering of the mounting plate <NUM> onto the bag may exert a downward force on the bag, assisting with deflation.

The bioreactor system <NUM> of the invention therefore provides an ergonomic means of installing the flexible bioprocessing bag, filters, filter heaters, and other consumables, and for organizing the various tubes connected to the bag. In contrast to existing systems, installation of such components can be carried out at waist-height from the side of the bioreactor vessel <NUM>, obviating the need for multiple operators and stepladders.

Turning now to <FIG>, a bioreactor system <NUM> according to another embodiment of the invention is illustrated. The bioreactor system <NUM> is generally similar in configuration to the bioreactor system <NUM> of <FIG> and includes a generally rigid bioreactor vessel or support structure <NUM> mounted atop a base <NUM> having a plurality of legs <NUM>. The vessel <NUM>, like vessel <NUM> is capable of supporting a single-use, flexible bioreactor bag in an interior space <NUM> thereof. The vessel <NUM> may likewise include one or more sight windows <NUM> and window <NUM> positioned at a lower area of the vessel <NUM>, the purposes of which have been hereinbefore described.

Similar to the vessel <NUM> of <FIG>, the vessel <NUM> may also include an access door <NUM> hingedly or pivotally connected to a sidewall of the vessel <NUM> and moveable between a closed position and an open or access position permitting access to the interior space <NUM>. The door <NUM> may likewise include a handle <NUM> that facilitates movement of the door between the open and closed positions. The door <NUM>, as discussed above, may be configured so as to define a portion of a boundary of one or more of the windows <NUM>, <NUM>, maximizing the size of the opening in the sidewall of the vessel <NUM> when the door <NUM> is in the open position, as disclosed above.

With further reference to <FIG>, the interior sidewall of the vessel <NUM> may include one or more vertical baffles <NUM> that project into the interior space <NUM>, as discussed above.

As illustrated in <FIG>, the bioreactor system <NUM>, like bioreactor system <NUM>, includes a tubing and component management apparatus <NUM> that facilitates installation and organization of tubing and consumable components of the bioreactor system <NUM>. The apparatus <NUM> includes a linear actuator <NUM> mounted to an exterior sidewall of the vessel <NUM>. The linear actuator <NUM> includes a shaft <NUM> that is selectively extendable and retractable in the vertical direction, denoted by arrow, B, as discussed in detail below. In an embodiment, the linear actuator <NUM> may take any form capable of moving the shaft <NUM> vertically such as, for example, a lead screw, a pneumatic actuator or a hydraulic actuator. In an embodiment, the actuator <NUM> may take the form of a cable and hand crank or motor-driven drive system, similar to that described above in connection with <FIG>. Other linear motion devices known in the art may also be utilized without departing from the broader aspects of the invention.

The apparatus <NUM> further includes a support frame <NUM> connected to the shaft <NUM> and moveable vertically therewith under control of the linear actuator <NUM>. As illustrated in <FIG>, the support frame <NUM> is suspended over the top opening of the bioreactor vessel <NUM> via a generally L-shaped support structure <NUM>. The support frame <NUM> includes a guide rail <NUM>, the purposes of which will be hereinafter described. The apparatus <NUM> also includes a mounting frame <NUM> that is slidably connected to the support frame <NUM> and, particularly, the guide rail <NUM> thereof. The mounting frame <NUM> is moveable in a horizontal direction away from, and towards, a central axis of the bioreactor vessel, as indicated by arrow, C. In an embodiment, a locking pin <NUM> is utilized to selectively restrain (or allow) horizontal movement of the mounting frame <NUM>.

In use, when installing a flexible bioprocessing bag prior to bioprocessing, the tubing and component management apparatus <NUM> starts in an initial position where the linear actuator <NUM> is extended such that the mounting frame <NUM> is positioned above the top opening of the bioreactor vessel <NUM>, as shown in <FIG>. The linear actuator <NUM> is then utilized to lower the mounting frame <NUM> into the interior space <NUM>, as illustrated in <FIG>. The L-shaped support arm <NUM> of the support frame <NUM> is configured so that when in a lowered position, the mounting frame <NUM> is posited about waist-height off of the floor and ergonomically accessible to an operator. As further shown in <FIG>, the door <NUM> may then be opened, providing easy access to the interior space <NUM>. With reference to <FIG>, the locking pin <NUM> can then be withdrawn, enabling the mounting frame <NUM> to move horizontally along the guide rail <NUM>, to an extended position where the mounting frame <NUM> extends through the door opening and out of the interior space <NUM> of the vessel <NUM>. The locking pin <NUM> can be utilized to lock the mounting frame <NUM> in its extended position, as also shown in <FIG>.

In this position, the mounting frame <NUM> is easily accessible for the mounting of consumable components including, for example, filters <NUM>, filter heaters and the like to the mounting frame <NUM>, as well as for the routing and management of tubing, as illustrated in <FIG>. As also shown therein, the flexible bioprocessing bag <NUM> can easily be installed in the interior space <NUM> and supported by the mounting frame <NUM> through one or more hooks <NUM> coupled to the mounting frame <NUM> (similar to those described above in connection with <FIG>). Once all of the tubing has been organized, the bag <NUM> installed, and various other components mounted securely to the mounting frame <NUM>, the locking pin <NUM> is withdrawn and the mounting frame <NUM> is pushed back into position within the interior space <NUM> and the locking pin is inserted to retain the mounting frame <NUM> in such position. The door <NUM> is then closed, as shown in <FIG>. With reference to <FIG>, the linear actuator <NUM> is then utilized to move the mounting frame <NUM> and the attached components to an operational position at a required height above the bioreactor vessel <NUM> (i.e., generally outside of the interior space <NUM>).

Similar to the embodiments disclosed above, in an embodiment, the apparatus <NUM> may be controlled by the control unit (not shown) of the bioreactor system <NUM> so that the mounting plate <NUM> can be automatically moved to an installation position (where the mounting plate <NUM> is extended through the door opening), an operational position (above the bioreactor vessel <NUM>), or a deflating position (e.g., moving downwardly continuously or intermittently as the bag <NUM> is deflated) in dependence upon a selected mode of operation of the bioreactor vessel <NUM>.

In addition to obviating the need for ladders and multiple operators to install the bioprocessing bag and other consumables, the bioreactor system <NUM> obviates the need of an operator to reach or lean into the interior space within the bioreactor vessel to install such components. In particular, the tubing and component management apparatus <NUM> is able to move vertically to a position where it can be easily accessed via a door in the sidewall of the vessel, without ladders, and the sliding mounting frame can be extended from the bioreactor vessel in the horizontal direction to provide an even greater ease of installation for such consumable components. The invention therefore provides for easier and quicker installation, as well repeatability in the manner in which the bioprocessing bag is installed.

In an embodiment, the tubing and component management apparatus, rather than being mounted to the outside of the vessel as described above, may be integrated with one of the internal baffles (e.g., baffle <NUM> of vessel <NUM>). <FIG> illustrate one such implementation of a tubing and component management apparatus <NUM>. The apparatus <NUM> includes a base plate <NUM> configured for mounting to the interior sidewall of a bioreactor vessel in place of one of the baffles. For example, in an embodiment, as shown in <FIG>, the base plate <NUM> may include a plurality of flanges <NUM> having slots configured to receive threaded studs that protruding from the interior sidewall of a bioreactor vessel, for mounting of the base plate to the vessel using nuts that are received on the threaded studs.

The apparatus <NUM> further includes a linear motion rail <NUM> coupled to the base plate <NUM>, such as via bolts or other fasteners, a linear motion block <NUM> slidably coupled to the rail <NUM> for linear, vertical movement therealong, a carriage plate <NUM> coupled to the linear motion block <NUM>, and a mounting frame <NUM> coupled to the carriage plate <NUM>. As shown in <FIG> and <FIG>, a baffle cover <NUM> encloses the base plate <NUM>, the rail <NUM> and the sliding block <NUM> and defines a hollow interior space between the cover <NUM> and the base plate <NUM>. The baffle cover <NUM> is shaped so as to provide a substantially equivalent function and performance as typical baffles, and may be, for example, generally triangular in cross section. As best shown in <FIG> and <FIG>, the baffle cover <NUM> includes a slot <NUM> in an apex thereof, through which the carriage plate <NUM> extends. The hollow interior and the slot <NUM> allow for vertical movement of the sliding block <NUM>, carriage plate <NUM> and mounting frame <NUM> along the guide rail <NUM>, as disclosed hereinafter.

As illustrated in <FIG>, the apparatus <NUM> also includes a cable hoist <NUM> or other driving mechanism having a cable <NUM> connected to the carriage plate <NUM>. The cable hoist <NUM> may be hand driven or motor driven, and is actuatable to let out the cable <NUM> or retract the cable <NUM> to selectively raise or lower the sliding block <NUM>, and thus the carriage plate <NUM> and mounting frame <NUM>, along the rail <NUM>, to adjust a vertical position of the mounting frame <NUM>.

As shown in <FIG>, the mounting frame <NUM> may be generally annular or semi-annular in shape, although other shapes and configurations are also envisioned. The mounting frame <NUM> may include a plurality of filter holder devices <NUM> for receiving and retaining filters <NUM>, as well as bag hooks, tubing holders, and similar mounting mechanisms for mounting of an array of consumable components to the mounting frame <NUM>.

<FIG> is a top plan view illustrating an exemplary bioreactor vessel <NUM> with which the tubing and component management apparatus <NUM> may be utilized. As illustrated therein, the vessel includes a plurality of internal baffles <NUM>, <NUM>, <NUM>. In an embodiment, baffle <NUM>, opposite access door <NUM>, may be replaced by the tubing and component management apparatus <NUM>. The tubing and component management apparatus <NUM>, as disclosed above, may be easily secured to the vessel sidewall, as well as easily removed during transportation as well as in the field, for service. As illustrated in <FIG>, the top of the mounting frame <NUM> is free from any cables or structures, which makes it easier to install the filters.

Similar to the embodiments disclosed above, the apparatus <NUM> may be controlled by the control unit (not shown) of the bioreactor system so that the mounting frame can be automatically lowered to an installation position before commencement of a bioprocessing operation, and raised to an operational position upon commencement of such operation.

<FIG> depict another a bioreactor system <NUM> that is generally similar in configuration to the bioreactor system <NUM> of <FIG>, where like reference numerals designate like parts. As illustrated therein, the tubing and component management apparatus <NUM>, however, includes a slightly different mounting frame for the mounting of various consumable components, tubes, and the like. In particular, the apparatus <NUM>, at the top of the shaft <NUM> of the linear actuator <NUM> includes a connector box <NUM>, and a floating frame <NUM> connected to the connector box <NUM>. The floating frame <NUM> includes a lower frame member <NUM> that is semi-annular in shape and is configured to support at least one consumable component such as, for example, the flexible bioprocessing bag <NUM>. The floating frame <NUM> additional includes an upper frame member <NUM> that is likewise semi-annular in shape and is configured to support at least one consumable component such as, for example, filters <NUM> and a pinch valve assembly <NUM>. The floating frame <NUM>, and the frame members <NUM>, <NUM> thereof, are mounted so as to be moveable vertically into and out of the interior space <NUM> within the bioreactor vessel <NUM> in the manner described above.

In particular, in use, when installing a flexible bioprocessing bag <NUM> prior to bioprocessing, the tubing and component management apparatus <NUM> starts in an initial position where the linear actuator <NUM> is extended such that the floating frame <NUM> and the frame members <NUM>, <NUM> thereof are positioned above the top opening of the bioreactor vessel <NUM>, as shown in <FIG>. The linear actuator <NUM> is then utilized to lower the floating frame <NUM> into the interior space <NUM>, as illustrated in <FIG>. The door <NUM> can then be opened (although it envisioned that it can be opened prior to lowering the floating frame <NUM>).

In this position, the floating frame <NUM> is easily accessible through the door opening for the mounting of consumable components including, for example, filters <NUM>, filter heaters, the flexible bag <NUM>, and a pinch valve assembly <NUM> for tubing, and the like, to the upper and lower frame members <NUM>, <NUM>, as well as for the routing and management of tubing, as illustrated in <FIG>. As also shown therein, the flexible bioprocessing bag <NUM> can easily be installed in the interior space <NUM> and supported by the lower frame member <NUM>. Once all of the tubing has been organized, the bag <NUM> installed, and various other components mounted securely to the floating frame <NUM>, the door <NUM> is then closed, as shown in <FIG>. With reference to <FIG>, the linear actuator <NUM> is then utilized to move the floating frame <NUM> and the attached components to an operational position at a required height above the bioreactor vessel <NUM> (i.e., generally outside of the interior space <NUM>).

Similar to the embodiments disclosed above, in an embodiment, the apparatus <NUM> may be controlled by the control unit (not shown) of the bioreactor system <NUM> so that the floating frame <NUM> can be automatically moved to an installation position (where the floating frame is received within the interior space <NUM> at about waist-height of an operator), an operational position (above the bioreactor vessel <NUM>), or a deflating position (e.g., moving downwardly continuously or intermittently as the bag <NUM> is deflated) in dependence upon a selected mode of operation of the bioreactor vessel/bioprocessing system <NUM>.

The embodiments of the tubing and component management apparatus described herein provide for an ergonomic means of installing the flexible bioprocessing bag, filters, filter heaters, and other consumables, and for organizing the various tubes connected to the bag. In contrast to existing systems, installation of such components can be carried out at waist-height from the side of the bioreactor vessel <NUM>, obviating the need for multiple operators and stepladders.

As indicated above, in addition to present difficulties installing the flexible bioprocessing bag and other components at the top of the bioreactor vessel, properly seating the impeller base plate of the flexible bioprocessing bag on the bottom of the bioreactor vessel during installation of the flexible bag may also present challenges. Accordingly, embodiments of the invention, in addition to providing for tubing and component management for the top of the flexible bag (namely, for tubing and components mounted above the flexible bag at the top of the bioreactor vessel), also provide for management of components at the bottom of the flexible bag. In particular, embodiments of the invention are directed to locating, locking and retaining mechanisms for locking the impeller base plate within the recess (e.g., the impeller base plate recess <NUM> of <FIG>), in the bottom of the bioreactor vessel, and an indicating mechanism for indicating that the base plate is properly positioned within the recess.

With reference to <FIG>, a component management system <NUM> in the form of a locking mechanism for an impeller base plate <NUM> for a bioprocessing system is shown. The system <NUM> includes a base plate <NUM> which is attached to the bottom of a flexible, single-use bioprocessing bag (not shown) for use in stirred-tank bioreactor systems like that shown in <FIG>. The base plate <NUM> may be mounted within an opening of the bottom of the flexible bioprocessing bag such as by welding, although other means of attachment may also be utilized without departing from the broader aspects of the invention. As is known, the base plate is configured to be received in a corresponding base plate recess <NUM> in the bottom <NUM> of a bioreactor vessel. As is known, the base plate <NUM> serves as an interface between an impeller (not shown) mounted to the base plate <NUM> interior to the flexible bag, and a rotating magnetic drive head (not shown) outside of the bag beneath the base plate <NUM>. The base plate <NUM> may also include a harvest port <NUM> for the connection of drain tubing to drain the flexible bag, and a plurality of ports <NUM> for the mounting of a sparger to the base plate <NUM> interior to the flexible bag.

As shown in <FIG>, the base plate <NUM> also includes a locating mechanism in the form of a slot <NUM> that extends from the underside of the base plate <NUM>. The slot <NUM> is configured to receive a corresponding tongue <NUM> that projects into a rearward portion of the recess <NUM> from the vessel bottom <NUM>. In an embodiment, it is contemplated that components of the locating mechanism may be reversed, such that the base plate may have a tongue projection that is received in a corresponding slot or groove in the vessel bottom <NUM>.

With further reference to <FIG>, the base plate <NUM> also includes a latching mechanism on the underside thereof opposite the slot <NUM>. In an embodiment, the latching mechanism includes a pair of downwardly depending latches <NUM> that are configured to be received by a corresponding locking/latching mechanism in the vessel bottom <NUM>, namely, in latch openings <NUM> in the vessel bottom <NUM>. In an embodiment, the latches <NUM> are generally L-shaped and are resilient such that when the base plate <NUM> is rotated downwardly about the tongue <NUM>, the base plate <NUM> is snapped into seated position within the recess <NUM> and the latches <NUM> engage the vessel bottom <NUM> to lock the base plate <NUM> in position. The latches <NUM> may be accessed beneath the vessel and pinched inwardly to release the base plate <NUM> from the recess <NUM>. While <FIG> illustrates two latches <NUM>, more than two latches, or a single latch, may be utilized without departing from the broader aspects of the invention.

In use, the flexible bag is inserted into the bioreactor vessel and the base plate <NUM> is angled as illustrated in <FIG> such that the tongue <NUM> is received in the slot <NUM> of the base plate <NUM>. The front of the base plate <NUM> is then urged downwardly until the latches <NUM> are received in the recesses <NUM> and snap into place to retain the base plate <NUM> in the recess. This ensures the base plate is constrained in all three axes.

Turning now to <FIG> another component management system <NUM> in the form of a locking/latching mechanism for an impeller base plate, according to another embodiment of the invention is shown. The system <NUM> includes a base plate <NUM> which may be attached to the bottom of a flexible, single-use bioprocessing bag as described above, and which is configured to be received in a corresponding base plate recess in the bottom of a bioreactor vessel. As is known, the base plate <NUM> may include a harvest port <NUM> for the connection of drain tubing to drain the flexible bag, and a plurality of ports <NUM> for the mounting of a sparger to the base plate <NUM> interior to the flexible bag.

Similar to the base plate <NUM> of <FIG>, the base plate <NUM> includes a rear slot <NUM> that extends from the underside of the base plate <NUM>, and which is configured to receive a corresponding tongue (not shown) that projects into a rearward portion of the recess in the bottom of the bioreactor vessel. As best shown in <FIG>, the base plate <NUM> also includes a forward catch <NUM> that extends downwardly from an underside of the base plate <NUM>. In an embodiment, the catch <NUM> is generally U-shaped or L-shaped having a catch member <NUM> that lies in a plane generally parallel to a body of the base plate <NUM>.

As best shown in <FIG>, the system <NUM> also includes a latch mechanism <NUM> having a latch member <NUM> that is configured to engage the catch member <NUM> of the catch <NUM>. As illustrated therein, the latch member <NUM> is attached to the distal end of an elongate shaft <NUM>, opposite a handle <NUM>. The shaft <NUM> extends through a housing <NUM> and is connected to a spring, e.g., coil spring <NUM>, within the housing <NUM>. The spring <NUM> biases the latch member <NUM> away from the housing <NUM> and towards the catch member <NUM> on the underside of the base plate <NUM>, as discussed hereinafter. The housing <NUM> is configured for mounting to the exterior bottom of the bioreactor vessel adjacent to the base plate recess. For example, in an embodiment, the housing <NUM> may include mounting flanges <NUM> for attaching the housing <NUM> to the bottom of the bioreactor vessel using bolts or screws.

As best shown in <FIG>, in an embodiment, the latch member <NUM> may be offset from a longitudinal axis defined by the shaft <NUM>. As also shown therein, in an embodiment, the latch member <NUM> may have a sloped or angled contact surface <NUM>. This surface functions to translate a downward force exerted on the latch member <NUM> by the catch member <NUM> into a horizontal force that urges the shaft <NUM> rearwardly against the spring bias of the coil spring <NUM>, as discussed hereinafter.

In use, the flexible bag is inserted into the bioreactor vessel and the base plate <NUM> is angled such that the tongue that projects into the recess in the bottom of the bioreactor vessel is received in the slot <NUM> of the base plate <NUM>. The front of the base plate <NUM> is then urged downwardly until the bottom of the catch member <NUM> contacts the angled surface <NUM> of the latch member <NUM> of the latch mechanism <NUM>. Continued downward urging of the base plate <NUM> causes the catch member <NUM> to exert a force on the angled surface <NUM> of the latch member <NUM>, causing the latch member <NUM> and the shaft <NUM> to move rearwardly against the spring bias of the coil spring <NUM>. As the catch member <NUM> passes the lower edge of the angled surface <NUM>, the spring bias of the coil spring <NUM> causes the shaft <NUM> and latch member <NUM> to translate forwardly, in the direction of arrow, A, in <FIG>. In this position, the latch member <NUM> extends over the catch member <NUM>, locking the base plate <NUM> in position within the recess. This ensures the base plate is constrained in all three axes. In an embodiment, the handle <NUM> may include a visual feature such as visible demarcation lines or features to indicate a locked and unlocked state of the base plate <NUM>.

<FIG> and <FIG> are cross sectional views of the base plate <NUM> in locked position within a recess <NUM> in the bottom of a bioreactor vessel <NUM>. As shown, the tongue <NUM> in the bottom of the vessel <NUM> is received in the slot <NUM>, and the latch member <NUM> engages the catch <NUM> to retain the base plate <NUM> in the recess <NUM>.

During unloading of the flexible bag, an operator may simply pull on the handle <NUM> to move the shaft <NUM> and latch member <NUM> against the spring bias, to a position in which the latch member <NUM> does not engage the catch <NUM>. In this position, the base plate <NUM> may be freely rotated out of the recess and removed.

Turning now to <FIG> another component management system <NUM> in the form of a locking/latching mechanism and indicator for an impeller base plate, according to another embodiment of the invention is shown. The system <NUM> includes a base plate <NUM> which may be attached to the bottom of a flexible, single-use bioprocessing bag as described above, and which is configured to be received in a corresponding base plate recess in the bottom of a bioreactor vessel. As is known, the base plate <NUM> may include a harvest port <NUM> for the connection of drain tubing to drain the flexible bag, and a plurality of ports <NUM> for the mounting of a sparger to the base plate <NUM> interior to the flexible bag.

Similar to the base plate <NUM> of <FIG> and base plate <NUM> of <FIG>, the base plate <NUM> may include a rear slot (not shown) that extends from the underside of the base plate <NUM>, and which is configured to receive a corresponding tongue (not shown) that projects into a rearward portion of the recess in the bottom of the bioreactor vessel. As best shown in <FIG>, the base plate <NUM> also includes a forward catch <NUM> that extends downwardly from an underside of the base plate <NUM>. In an embodiment, the catch <NUM> is generally U-shaped or L-shaped having a catch member <NUM> that lies in a plane generally parallel to a body of the base plate <NUM>.

As best shown in <FIG>, the system <NUM> also includes a latch mechanism <NUM> having a latch member <NUM> that is configured to engage the catch member <NUM> of the catch <NUM>. As illustrated therein, the latch member <NUM> is attached to the distal end of a shaft <NUM>, opposite a handle <NUM>. The shaft <NUM> extends through a housing <NUM> and is connected to handle <NUM>. The housing <NUM> is configured for mounting to the exterior bottom of the bioreactor vessel adjacent to the base plate recess, as shown in <FIG>. For example, in an embodiment, the housing <NUM> may include mounting flanges for attaching the housing <NUM> to the bottom of the bioreactor vessel using bolts or screws.

As best shown in <FIG>, in an embodiment, the latch member <NUM> may be offset from a longitudinal axis defined by the shaft <NUM>. As also shown therein, in an embodiment, the latch member <NUM> may have a sloped or angled contact surface <NUM>. In order to lock the base plate <NUM> to the bottom of the bioreactor vessel, a user can rotate handle <NUM>, which cause shaft <NUM> to extend, resulting in latch member <NUM> engaging with catch member <NUM>, as best illustrated in <FIG>.

The mechanical locking system <NUM> for the impeller base plate as described above further includes an indicator mechanism <NUM>. As best shown in <FIG>, <FIG>, the indicator mechanism <NUM> includes a plunger <NUM> that extends through the bottom of the bioreactor vessel into the recess. The plunger <NUM> is attached to a rocker arm <NUM> that further extends into housing <NUM>. Located at the end of rocker arm <NUM> is an indicator <NUM>. As best shown in <FIG>, <FIG>, the indicator is a portion of rocker arm <NUM> or a pointer (or other visual indicating means) attached to an end of rocker arm <NUM> (e.g., a cone shaped attachment) along with an indicator panel that is attached to, or a portion of, housing <NUM>, as illustrated by <FIG>. The indicator panel provides two visual indication regions (i.e., a top portion and a bottom portion), corresponding to a proper positioning and an improper positioning of the base plate <NUM>. For example, the top portion may be colored green, while the bottom portion may be colored red.

In use, prior to attachment of the base plate <NUM> to the bottom of the bioreactor vessel, plunger <NUM> is in an extended position such that the top <NUM> of the plunger <NUM> protrudes into the recess in the bioreactor vessel. This is accomplished via a biasing mechanism <NUM> (e.g., a spring) located in a cutout in the bioreactor vessel. In this configuration, and when the base plate <NUM> is improperly positioned, rocker arm <NUM> slopes downwardly, such that the indicator <NUM> is located on the bottom portion of the indicator panel, as best illustrated by <FIG>. When the base plate <NUM> is properly positioned the plunger <NUM> is pushed down into the recess, which causes rocker arm <NUM> to pivot about a pivoting arm <NUM>, which raises the indicator <NUM> relative to the indicator panel, as best illustrated by <FIG>. In this way, the indicator <NUM> moves up and down on the indicator panel, providing an indication of whether the base plate <NUM> is properly positioned.

According to alternative embodiments, the indicator mechanism <NUM> includes a sensor associated with, or configured to replace, the plunger. The sensor is configured to indicate when the base plate is properly positioned. By way of example, the sensor can be a proximity sensor that emits a signal (e.g., light, electromagnetic radiation) that is configured to indicate when the base plate is properly position. By way of a further example, the sensor can be a mechanical sensor (e.g., a mechanical switch) that is depressed/actuated upon proper placement of the base plate. An output signal from sensor is configured to provide an indication (e.g., visual, tactile, or auditor) when proper placement occurs.

According to further alternative embodiments, the rocker arm is configured to move from a position in which it prevents the locking/latching mechanism from engaging the base plate to a position in which the locking/latching mechanism is free to engage the base plate, corresponding to an improper and proper position of the base plate within the recess, respectively. By way of example, the rocker arm may include a portion that is configured to abut a portion of the locking/latching mechanism of any of the aforementioned embodiments, such that when the base plate is improperly positioned the rocker arm prevents the locking mechanism from properly engaging the base plate (e.g., prevents handle <NUM> fully swinging into position). Only when the base plate is properly position, and thereby the rocker arm moves, is the locking mechanism allowed to engage the base plate.

It is noted that the location of plunger <NUM> (or sensor) within the recess of the bottom of the bioreactor vessel, according to embodiments, is generally centrally located. According to a preferred embodiment, and as illustrated by <FIG>, the plunger is located adjacent to a cutout in the bottom of the bioreactor vessel close to the center of recess. This is a preferred location, as it ensures that the plunger is only depressed when the base plate <NUM> is properly placed. If the plunger is peripherally placed there is a chance that it may be depressed even when the base plate <NUM> is improperly placed. Advantageously, indicator mechanism <NUM> provides a clear indication of whether the base plate is properly positioned within the recess. The indicator mechanism further addresses potential problems associated with the difficulties in knowing whether the base plate is properly positioned, even when the front or back of the base plate is latched within the recess.

The mechanical locking systems for the impeller base plate described herein provide a means for securely locking the impeller base plate in the recess of the bottom of the bioreactor vessel during installation of the flexible bag. In addition, the mechanisms hereinbefore described provide a tactile, visual or other indication that the base plate is in seated and locked position within the recess. As also described above, while securely locked to the vessel, the base plate can still be easily removed upon completion of a bioprocessing operation.

It is contemplated that the base plate locking system described herein in connection with <FIG> may be incorporated into any stirred tank bioreactor vessel known in the art. Still further, it is contemplated that the base plate locking systems of the invention may be incorporated into any the bioreactor vessels illustrated in <FIG>, which include a tubing and component management system, as described herein. In particular, in an embodiment, a bioreactor vessel may include one of, or both of, a base plate locking mechanism for securing the base plate to the bottom of the bioreactor vessel, and a tubing and component management system for arranging and securing consumable components above the flexible bag. The combination of the base plate locking mechanism and the tubing and component management system provides for a bioreactor vessel that facilitates installation of consumable components and provides for an ease of use heretofore not seen in the art.

In an embodiment, a bioreactor vessel is provided. The bioreactor vessel includes a bottom, a peripheral sidewall, the bottom and the peripheral sidewall defining an interior space for receiving a flexible bioprocessing bag, a recess in the bottom for receiving a base plate of the flexible bioprocessing bag, a locking mechanism configured to retain the base plate in the recess, and an indicator mechanism configured to indicate when the base plate is properly positioned in the recess. In an embodiment, the locking mechanism includes a latch, wherein the latch is moveable between an engagement position where the latch engages the base plate when the base plate is positioned in the recess in the bottom of the bioreactor vessel to retain the base plate in the recess, and a clearance position where the base plate can be withdrawn from the recess. In an embodiment, the latch is spring-biased toward the engagement position. In an embodiment, the locking mechanism includes a handle that is operable to move the latch from the engagement position to the clearance position. In an embodiment, the latch includes an angled upper surface configured to translate a downward force from the base plate into a lateral force for moving the latch to the clearance position against the spring-bias during installation of the base plate in the recess. In an embodiment, the indicator mechanism includes a plunger, a rocker arm, and an indicator. In an embodiment, the plunger initially protrudes into the recess. In an embodiment, when the base plate is properly placed in the recess, the indictor moves in a direction opposite to movement of the plunger via the rocker arm, which provides the indication of proper placement. In an embodiment, the bioreactor vessel includes a tongue extending into the recess opposite the locking mechanism, the tongue being configured to engage a slot in a rear area of the base plate. In an embodiment, the locking mechanism includes at least one aperture adjacent to the recess and configured to receive at least one corresponding latch of the base plate. In an embodiment, the at least one aperture is a pair of apertures. In another embodiment, a bioprocessing apparatus is provided. The apparatus includes a flexible bioprocessing bag, and a base plate positioned at a bottom of the flexible bioprocessing bag and being shaped so as to be received in a corresponding recess in a bottom of a bioreactor vessel. The base plate includes a locating mechanism adjacent to a rear edge of the base plate, for cooperating with a corresponding locating feature on the bottom of the bioreactor vessel adjacent to the recess to locate the base plate in the recess, and a locking mechanism extending downwardly from an underside of the base plate opposite the locating mechanism, for cooperating with a corresponding locking device of the bioreactor vessel for retaining the base plate in the recess. The locating mechanism is one of a slot and a tongue, and the corresponding locating feature is the other of a slot and a tongue, or equivalents thereof. In an embodiment, the locking mechanism is a catch lying in a plane generally parallel to, and spaced from, a body of the base plate, and the locking device includes a latch configured to engage the catch. In an embodiment, the locking mechanism is at least one latch member, and the locking device includes a recess configured to receive the at least one latch member. In an embodiment, the at least one latch member is generally L-shaped. In an embodiment, the at least one latch member is resilient.

In yet another embodiment, a bioprocessing system is provided. The bioprocessing system includes a bioreactor vessel having a bottom and a peripheral sidewall defining an interior space, a recess in the bottom, a locking mechanism adjacent to the recess, an indicator mechanism, and a flexible bioprocessing bag positionable within the interior space, the flexible bioprocessing bag including a base plate at a bottom of the flexible bioprocessing bag. The base plate is configured to be received in the recess in the bottom of the bioreactor vessel. The locking mechanism is configured to engage the base plate to retain the base plate in the recess. In an embodiment, the locking mechanism includes a latch, and the base plate includes a catch. The latch is moveable between an engagement position where the latch engages the catch when the base plate is positioned in the recess to retain the base plate in the recess, and a clearance position where the base plate can be withdrawn from the recess. In an embodiment, the latch is spring-biased toward the engagement position. In an embodiment, the locking mechanism includes a handle that is operable to move the latch from the engagement position to the clearance position. In an embodiment, the latch includes an angled upper surface configured to translate a downward force from the catch of the base plate into a lateral force for moving the latch to the clearance position against the spring-bias during installation of the base plate in the recess. In the embodiment of the invention, the system includes a tongue extending into the recess opposite the locking mechanism, the tongue being configured to engage a slot in a rear area of the base plate. In an embodiment, the locking mechanism includes at least one aperture adjacent to the recess and configured to receive at least one latch depending downwardly from the base plate opposite the slot. In an embodiment, the indicator mechanism includes a plunger, a rocker arm, and an indicator. In an embodiment, the plunger initially protrudes into the recess. In an embodiment, when the base plate is properly placed in the recess, the indictor moves in a direction opposite to movement of the plunger via the rocker arm, which provides the indication of proper placement.

In an embodiment, a bioprocessing system is provided. The bioprocessing system includes a vessel defining an interior space for receiving a flexible bioprocessing bag, the vessel having an access door in a sidewall of the vessel and providing access to the interior space, and a tubing and component management apparatus mounted to the sidewall of the vessel and having a mounting frame for mounting of at least one consumable component of the bioprocessing system. The mounting frame is moveable vertically into and out of the interior space. In an embodiment, the mounting frame is moveable between and installation position where the mounting frame is positioned within the interior space of the vessel at a height where the mounting frame is accessible through the access door, and an operational position where the mounting frame is positioned generally above a top of the bioreactor vessel. In an embodiment, the tubing and component management apparatus includes a lifting mechanism for moving the mounting frame vertically along a centerline of the vessel. In an embodiment, the mounting frame is slidable in a direction generally perpendicular to the centerline of the vessel between a stowed position where the mounting frame is positioned within the interior space, and an access position where the mounting frame extends through an access door opening when the access door is in an open position. In an embodiment, the tubing and component management apparatus includes a locking device for selectively locking the mounting frame in the stowed position and the access position. In an embodiment, the lifting mechanism is a linear actuator. In an embodiment, the tubing and component management apparatus includes a support member mounted to a sidewall of the vessel, a boom extending from the support member generally over the vessel, and a sleeve extending downwardly from the boom along a centerline of the vessel, wherein the mounting frame includes a shaft that is received within the sleeve. In an embodiment, the lifting mechanism includes a cable extending from the mounting frame, through the sleeve and along the boom, wherein the cable is selectively extendable and retractable to selectively lower and raise the mounting frame. In an embodiment, the lifting mechanism is integrated with an internal baffle of the vessel. In an embodiment, the tubing and component management apparatus includes a guide rail mounted to an internal sidewall of the vessel and a carriage plate slidably connected to the guide rail, wherein the mounting frame is connected to the carriage plate for vertical movement along the guide rail. In an embodiment, the tubing and component management apparatus includes a baffle cover defining the internal baffle, wherein the baffle cover includes a slot through which the carriage plate extends. In an embodiment, the vessel includes a window in a sidewall of the vessel. The access door is movable between a closed position and an open position. When in the closed position, an edge of the access door defines at least a portion of a boundary of the window. In an embodiment, the mounting frame includes at least one slot, aperture or bracket for receiving the at least one consumable component. In an embodiment, the at least one consumable component is a tube, a filter or a filter heater.

In another embodiment, a method for installing components of a bioprocessing system is provided. The method includes the steps of lowering a mounting frame into a vessel through a top opening of the vessel, opening an access door in a sidewall of the vessel to access the mounting frame, mounting at least one consumable component to the mounting frame, closing the access door, and raising the mounting frame to a position adjacent to a top of the vessel. In an embodiment, the method also includes the step of moving the mounting frame in a direction generally perpendicular to a centerline of the vessel to extend the mounting frame through the access door opening. In an embodiment, the steps of lowering the mounting frame and raising the mounting frame are carried out automatically by a control unit of the bioprocessing system. In an embodiment, the method also includes actuating a lift assembly to lower or raise the mounting frame.

In yet another embodiment, a bioprocessing system is provided. The bioprocessing system includes a vessel defining an interior space for receiving a flexible bioprocessing bag, the vessel having an access door in a sidewall of the vessel and providing access to the interior space through an access door opening, and a tubing and component management apparatus mounted to the sidewall of the vessel and having a mounting frame for mounting of at least one consumable component of the bioprocessing system. The mounting frame is moveable between and installation position where the mounting frame is positioned within the interior space of the vessel at a height where the mounting frame is accessible through the access door, and an operational position where the mounting frame is positioned generally above a top of the bioreactor vessel. The tubing and component management apparatus includes a lift mechanism for moving the mounting frame between the installation position and the operational position. In an embodiment, the mounting frame is slidable in a direction generally perpendicular to the centerline of the vessel between a stowed position where the mounting frame is positioned within the interior space, and an access position where the mounting frame extends through an access door opening when the access door is in an open position. In an embodiment, the tubing and component management apparatus is mounted to an internal side of the sidewall of the vessel. In an embodiment, the lift mechanism includes a linear actuator. In an embodiment, the vessel includes a window in a sidewall of the vessel, wherein the access door is movable between a closed position and an open position, and wherein when in the closed position, an edge of the access door defines at least a portion of a boundary of the window.

Claim 1:
A bioprocessing apparatus, comprising:
a flexible bioprocessing bag (<NUM>); and
a base plate (<NUM>, <NUM>, <NUM>) positioned at a bottom of the flexible bioprocessing bag (<NUM>) and being shaped so as to be received in a corresponding recess (<NUM>) in a bottom (<NUM>) of a bioreactor vessel (<NUM>, <NUM>), the base plate (<NUM>, <NUM>, <NUM>) including:
a locating mechanism (<NUM>) adjacent to a rear edge of the base plate (<NUM>, <NUM>, <NUM>), for cooperating with a corresponding locating feature (<NUM>) on the bottom (<NUM>) of the bioreactor vessel (<NUM>, <NUM>) adjacent to the recess (<NUM>) to locate the base plate (<NUM>, <NUM>, <NUM>) in the recess (<NUM>), characterised in that the locating mechanism (<NUM>) comprises one of a slot and a tongue and the corresponding locating feature (<NUM>) comprises the other of a slot and a tongue; and
a locking mechanism (<NUM>) extending downwardly from an underside of the base plate (<NUM>, <NUM>, <NUM>) opposite the locating mechanism (<NUM>), for cooperating with a corresponding locking device of the bioreactor vessel (<NUM>, <NUM>) for retaining the base plate (<NUM>, <NUM>, <NUM>) in the recess (<NUM>).