System and method for adjusting filter height of a biotreatment system

Abstract

A bioreactor system for performing a biomanufacturing process is provided. The system includes a bioreactor vessel, an exhaust filter and an associated filter heater, and a height adjustment mechanism connected to the exhaust filter and the associated filter heater, and the bioreactor vessel. The exhaust filter is fluidly connected to a single-use bioreactor bag located within the bioreactor vessel via at least one tube, and a height adjustment mechanism adjusts the height of the exhaust filter and associated filter heater relative to the top surface of the single-use bioreactor bag. By adjusting the height of the exhaust filter and the associated filter heater, pipe kink is avoided, thereby ensuring that excessive pressurization of a single use bioreactor bag is avoided.

Description

TECHNICAL FIELD

[0001] Embodiments of the present invention generally relate to bioprocessing systems and methods, and more particularly to systems and methods for adjusting filter height and associated filter heat of a bioprocessing system. BACKGROUND

[0002] A wide variety of vessels, devices, components, and unit operations are known for performing biochemical and / or biological processes and / or manipulating the liquids and other products of such processes. To avoid the time, expense, and difficulty associated with sterilizing vessels used in biopharmaceutical manufacturing processes, single-use or disposable bioreactor bags and single-use mixer bags are used as such vessels. For example, 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.

[0003] Single-use or disposable containers are increasingly used in the biopharmaceutical industry. Such containers can be flexible or collapsible plastic bags supported by an outer rigid structure, such as a stainless steel shell or vessel. The use of sterilized disposable bags eliminates the time-consuming step of vessel cleaning and reduces the likelihood of contamination. The bag can be positioned within the rigid vessel and filled with the desired fluid for mixing. Depending on the fluid being processed, the system can include several fluid lines and different sensors, probes, and ports coupled with the bag for monitoring, analysis, sampling, and fluid transfer. For example, multiple ports can typically be located at the front of the bag and can be accessed through an opening in the sidewall of the vessel, which provides a connection point for sensors, probes, and / or fluid sampling lines. Additionally, 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 a harvest line to be connected to the bag for harvesting and draining the bag after the bioprocessing is complete.

[0004] Typically, an agitator assembly disposed within the bag is used to mix the fluids. Existing agitators are either top-driven (having a shaft extending downward into the bag with one or more impellers mounted on the shaft) or bottom-driven (having an impeller disposed in the bottom of the bag, which 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 the bag and a rotating magnetic agitator (also referred to as an "impeller" in this context) inside the bag. Movement of the magnetic drive head transfers torque and, thus, rotates the magnetic agitator, allowing the agitator to mix the fluids within the vessel. Magnetic coupling of the agitator inside the bag to a drive system or motor outside the bag and / or bioreactor vessel eliminates contamination issues, allows for a completely closed system, and prevents leaks. Because there is no need for the drive shaft to penetrate the bioreactor vessel wall to mechanically spin the agitator, a magnetically coupled system also eliminates the need for a seal between the drive shaft and the vessel.

[0005] During the cell culture process, the bag is inflated, and fluids and gases are introduced into the bag. Such gases may include air, CO2, oxygen, and N2. Additionally, culture medium may be added periodically (or continuously) throughout the culture process. Gases and fluids are also removed from the bag during the culture process. Typically, gases are removed through an exhaust line (e.g., a tube) connected to an exhaust filter attached to an external vessel at the top of the bag. A filter heater is typically wrapped around the filter to minimize condensation within the exhaust line, thereby reducing fouling of the exhaust filter. However, because the bag is inflated and gas is being added to the system, the amount of gas inflated varies over the course of the cell culture process. In the event that the bag is overinflated, the exhaust line is pushed upward. Because the exhaust filter is attached to an external vessel, the exhaust filter has a fixed height. This, in turn, causes the exhaust line to bend or otherwise kink, causing the bag pressure to rise above a safe level (i.e., because the exhaust line is at least partially blocked, preventing gas from leaving the bag at a sufficient rate). Currently, when this occurs, the culture must be stopped or paused, otherwise the bag will rupture due to over-pressurization. A new (or identical) vent filter can then be attached to the bag using a shorter vent line, and the culture process can then be resumed. However, these steps are cumbersome, require pausing the culture, which can harm cell viability, and require additional supplies (e.g., additional tubing, connectors, etc.).

[0006] In view of the above, a need exists for a mechanism to adjust the height of the exhaust filter and associated filter heater so that overinflation of the bag does not cause kinking in the exhaust line. Summary of the Invention

[0007] A first aspect of the invention relates to a method for adjusting a height of an exhaust filter and associated filter heater. The method comprises: attaching the exhaust filter and associated filter heater to a height adjustment mechanism; attaching the height adjustment mechanism to a bioreactor vessel; fluidly connecting the exhaust filter to a single-use bioreactor bag located within the bioreactor vessel via at least one tube; and adjusting a height of the exhaust filter and associated filter heater relative to a top surface of the single-use bioreactor bag. According to an embodiment, the step of adjusting occurs after inflating the single-use bioreactor bag, such that a distance between the exhaust filter and associated filter heater and the top surface of the single-use bioreactor bag increases, such that the at least one tube straightens. By straightening the tube, overpressure created in the single-use bioreactor bag due to kinking of the at least one tube is mitigated.

[0008] In an embodiment, the height adjustment mechanism comprises at least one track, and the adjusting comprises sliding the exhaust filter and associated filter heater along the track. The height adjustment mechanism further comprises: at least one clamp; and at least one plunger, such that the sliding the exhaust filter and associated filter heater along the track comprises: rotating the plunger in a first direction, such that the plunger unlocks from the track; and moving the exhaust filter and associated filter heater along the track. After the exhaust filter and associated filter heater are moved along the track, the method further comprises rotating the plunger in a second direction to lock the plunger within a slot of the track.

[0009] In a further embodiment, the height adjustment mechanism comprises: a lead screw located within a channel of the at least one track; and a knob located on a first end of the lead screw, wherein the sliding the exhaust filter and associated filter heater along the track comprises rotating the knob.

[0010] According to any embodiment, the height of the exhaust filter and associated filter heater relative to the top surface of the single-use bioreactor bag is automatically adjusted based on a height of the top surface of the single-use bioreactor bag or a pressure sensed within the single-use bioreactor bag. In one embodiment, the automatically adjusting comprises activating a motor when the sensed pressure exceeds a threshold value.

[0011] A second aspect of the present invention relates to a bioreactor system comprising: a bioreactor vessel; an exhaust filter and associated filter heater; and a height adjustment mechanism connected to the exhaust filter and associated filter heater and to the bioreactor vessel; wherein the exhaust filter is fluidically connected to a single-use bioreactor bag located within the bioreactor vessel via at least one tube; wherein the height adjustment mechanism adjusts the height of the exhaust filter and associated filter heater relative to a top surface of the single-use bioreactor bag.

[0012] In embodiments, the height adjustment mechanism comprises: at least one track, wherein the height of the exhaust filter and associated filter heater is adjusted by sliding along the at least one track. The height adjustment mechanism further comprises: at least one clamp; and at least one plunger, wherein rotation of the plunger in a first direction unlocks the plunger from the track such that the exhaust filter and associated filter heater can travel along the track. Rotation of the plunger in a second direction locks the plunger within a slot of the track such that the exhaust filter and associated filter heater cannot move along the track.

[0013] In further embodiments, the height adjustment mechanism further comprises: a lead screw located within a channel of the at least one track; and a knob located on a first end of the lead screw, wherein the height of the exhaust filter and associated filter heater is adjusted by rotating the knob. According to any embodiment, the system further comprises: at least one sensor configured to determine the height of the top surface or a sensed pressure within the single-use bioreactor bag; and a motor, wherein the height of the exhaust filter and associated filter heater is automatically adjusted by activating the motor when the sensed pressure or the height of the top surface exceeds a threshold value. BRIEF DESCRIPTION OF DRAWINGS

[0014] The present invention will be better understood by reading the following description of non-limiting embodiments, to be read in connection with the accompanying drawings, wherein: Figure 1 is a perspective view of a bioprocessing system according to an embodiment of the present invention.

[0015] Figure 2 is a perspective view of a component management apparatus of the bioprocessing system of Figure 1 is a perspective view of a component management apparatus of the bioprocessing system of

[0016] Figure 3A and Figure 3B show a height adjustment mechanism according to an embodiment of the present invention in an assembled view and in an exploded view, respectively.

[0017] Figures 4A-4DA method for adjusting the height of an exhaust filter and an associated filter heater according to an embodiment of the present invention is shown. Figures 3A-3B Operation of the height adjustment mechanism.

[0018] Figure 5 An alternative height adjustment mechanism is shown according to an embodiment of the present invention.

[0019] Figure 6A and Figure 6B Shown is how operation of the height adjustment mechanism straightens a kinked tube connected to an exhaust filter in accordance with an embodiment of the present invention. DETAILED DESCRIPTION

[0020] Hereinafter, reference will be made in detail to exemplary embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts.

[0021] As used herein, the terms "flexible" or "collapsible" refer to structures or materials that are pliable or capable of bending without breaking, and may also refer to compressible or expandable materials. An example of a flexible structure is a bag formed from polyethylene film. The terms "rigid" and "semi-rigid" are used interchangeably herein to describe a "non-collapsible" structure, that is, a structure that does not fold, collapse, or otherwise deform to substantially reduce its extended dimension under normal forces. Depending on the context, "semi-rigid" may also refer to a structure that is more flexible than a "rigid" element, such as a bendable tube or catheter, but still a structure that does not collapse longitudinally under normal conditions and forces.

[0022] As used herein, " vessel " means flexible bag, flexible container, semi-rigid container, rigid container or flexible or semi-rigid pipe, as the case may be. As used herein, " vessel " is intended to include bioreactor vessels with flexible or semi-rigid wall or wall portion, single-use flexible bag and other containers or conduits used conventionally in biological or biochemical treatment, including, for example, cell culture / purification system, mixing system, medium / buffer preparation system and filtration / purification system (for example, chromatography and tangential flow filter system) and their associated flow path. As used herein, term " bag " means, for example, as a flexible or semi-rigid container or vessel of a bioreactor or mixer for internal inclusions. As used herein, " consumable " or " consumable component " means a device or component intended to be regularly replaced due to wear or use.

[0023] Embodiments of the present invention provide a bioprocessing system, and in particular, an exhaust filter height adjustment mechanism for a bioreactor system. In one embodiment, the bioprocessing system includes: a vessel defining an interior space for receiving a flexible bioprocessing bag, the vessel having an access door in a side wall of the vessel providing access to the interior space; and a component management device mounted to the side wall of the vessel and having a mounting frame for mounting at least one consumable component of the bioprocessing system.

[0024] refer to Figure 1 , a bioprocessing system 10 (also referred to herein as a bioreactor system 10) is shown according to an embodiment of the present invention. The bioreactor system 10 includes a substantially rigid bioreactor vessel or support structure 12 mounted atop a base 14 having a plurality of legs 16. The vessel 12 can be formed, for example, of stainless steel, a polymer, a composite material, glass, or other metal, and can be cylindrical in shape, although other shapes can also be utilized without departing from the broader aspects of the present invention. The vessel 12 can be of any shape or size as long as it is capable of supporting a single-use flexible bioreactor bag in its interior space 18. For example, according to one embodiment of the present invention, the vessel 12 is capable of accepting and supporting a 10L-2000L flexible or collapsible bioprocessing bag.

[0025] The vessel 12 may include one or more viewing windows 20 that allow an operator to view the liquid level within the flexible bag positioned within the interior space 18, as well as a window 22 positioned at a lower region of the vessel 12. The window 22 allows access to the interior of the vessel 12 so that various sensors and probes (not shown) can be inserted and positioned within the flexible bag, and one or more fluid lines can be connected to the flexible bag so that fluids, gases, etc. can be added or withdrawn from the flexible bag. Sensors / probes and controllers used to monitor and control important process parameters include any one or more of the following, and combinations thereof: for example, temperature, pressure, pH, dissolved oxygen (DO), dissolved carbon dioxide (pCO2), mixing rate, and gas flow rate.

[0026] In embodiments, the vessel 12 includes an access door 24 hingedly or pivotally connected to a sidewall of the vessel 12, thereby permitting access to the interior space 18. The door 24 can include a handle 26 that facilitates movement of the door between an open position and a closed position. In embodiments, the door 24 can be configured and positioned such that, when the door 24 is in the closed position, a lower edge of the door 24 forms an upper edge or boundary of the window 22, and / or a side edge of the door 24 forms an edge or boundary of the window 20. By having the edges of the door 24 define one or more boundaries of the windows 22, 24, a continuous and unobstructed access opening in the sidewall of the vessel is formed by the opening 20, the opening 22, and the open door 24 (i.e., the opening in which the door is received) when the door 22 is in the open position. Thus, the area of the continuous access opening formed in the sidewall of the vessel 12 when the door is in the open position is equivalent to the combined area of the door 24, the window 22, and the window 24. This provides a greater gap and access to the interior space 18 than would otherwise be possible if the door and window were separated by a portion of the sidewall of the vessel 12.

[0027] Further reference is made to Figure 1 , the interior sidewall of the vessel 12 can include one or more vertical baffles 28 that project into the interior space 18. The baffles 28 can be generally triangular in cross-section, although shapes and configurations known in the art can also be utilized without departing from the broader aspects of the present invention. The baffles 28 are configured to contact and bias the flexible bag inward (when installed in the interior space 18) for purposes known in the art.

[0028] As further shown in Figure 1 and Figure 2 , the bioreactor system 10 also includes a component management apparatus 100. The apparatus 100 includes a frame 102 that is utilized to connect various components to the flexible bag. The frame 102 can take the form of a semicircle or curved track that generally mimics the outer diameter of the vessel 12. In particular, Figure 2 is shown how an exhaust filter with an associated filter heater 134 can be attached to the frame 102. As shown, each exhaust filter and associated filter heater 134 can be attached to a frame portion 124 via a height adjustment mechanism 140. In particular, as best shown in Figure 2 , FIG. 3, and Figure 5 , each exhaust filter and associated filter heater 134 is attached to the height adjustment mechanism 140, 150 via a fastener 146, which in turn is attached to the frame 102 via a fastener 139. As shown by these figures, the height adjustment mechanisms 140, 150 can be attached directly to the track Figure 5 ) or a protruding portion (e.g., flange) 124 of the frame 102.

[0029] As will be discussed in greater detail below, the height adjustment mechanisms 140, 150 are configured to adjust the height of the exhaust filter and associated filter heater 134 relative to the frame 102 and vessel 12 so that the distance between the exhaust filter and associated filter heater 134 and the single-use bag can be adjusted before, during, and / or after a cell culture process occurs within the single-use bag. Specifically, during the cell culture process, the exhaust filter and associated filter heater 134 are fluidly connected to the single-use bag via at least one tube so that gases introduced (and generated) during cell culture can exit the single-use bag. The height of the exhaust filter and associated filter heater 134 can be changed to accommodate changes in the inflation of the single-use bag due to changes in the amount of gas entering (or generated) the single-use bag. This ensures that the integrity of the fluid connection between the single-use bag and the exhaust filter is properly maintained.

[0030] According to an embodiment of the present invention, the height adjustment mechanism 140 includes a back plate 141 that is attached to an attachment plate 135 of the exhaust filter and associated filter heater 134 via fasteners 142. The height adjustment mechanism 140 further includes a rail 143 that is attached to the frame 102 via fasteners 139 and a clamp 146 that is attached to the back plate 141 via fasteners 146. Figures 3A-4B , the track 143 generally has an inverted "T" shape with the slot 144 located within its vertical section. The clamp 145 is shaped so that the vertical section of the track 143 can slide within a recess in the clamp 145. The height adjustment mechanism 140 further includes a plunger 147 that is inserted into a hole in the clamp 145. The length of the plunger 147 is such that it penetrates the clamp 145 and enters the slot 144. A nut 148 is screwed onto the plunger 148. The slot 144 includes an array of protrusions (e.g., teeth) 149 (as in FIG. Figure 4C and Figure 4D ), such that the plunger 147 can be seated within the recesses (i.e., circular cutouts) of the track 143. Thus, when the handle of the plunger 147 is rotated in a first direction (e.g., in a clockwise direction), the plunger 147 advances into the slot 144 and seats within one of the recesses (see, e.g., FIG. Figure 4D ), thereby locking the exhaust filter and associated filter heater 134 and preventing movement of the exhaust filter and associated filter heater 134 relative to the track 143. Similarly, when the handle of the plunger is rotated in a second direction (e.g., in a counterclockwise direction), the plunger 147 retracts out of the recess and track 143 (see, e.g., FIG. Figure 4C), thereby unlocking and allowing movement of the exhaust filter and associated filter heater 134 relative to the track 143.

[0031] With such a configuration of the components, the height adjustment mechanism 140 is able to adjust the height of the exhaust filter and associated filter heater 134. In particular, the exhaust filter and associated filter heater 134 is slidable along the length of the track 143. To accomplish this, and as shown, the user rotates the handle of the plunger 147 in a counter-clockwise direction (as indicated by the arrow in Figures 4A-4D Figure 4A This unlocks the height adjustment mechanism 140. The user can then slide the exhaust filter and associated filter heater 134 along the track 143 to a desired height (as indicated by the arrow in Figure 4B To prevent further movement of the exhaust filter and associated filter heater 134, the user then rotates the handle in a clockwise direction, which causes the plunger to seat within a desired indentation in the track 143, thereby locking the height of the exhaust filter and associated filter heater 134.

[0032] Figure 5 An alternative embodiment of a height adjustment mechanism 150 is shown. As shown, the height adjustment mechanism 150 also includes a track 155 having a generally inverted "T" shape. The lower portion of the track 155 is fastened to the frame 102 via the fastener 139, as previously discussed. The track 155 has a channel 152 formed along at least a portion of its length, with a lead screw 153 spanning the length of the channel 152. The top of the lead screw terminates at a knob 151 located on the top of the track 155. A back plate 154 fastened to the attachment plate 135 (and thereby to the exhaust filter and associated filter heater 134) has a portion that protrudes into the channel through which the lead screw 153 passes. In particular, a portion of the back plate 154 is configured to fit within the channel 153 and includes a bore therethrough through which the lead screw passes. In this way, the portion of the back plate 154 acts as a nut threaded onto the lead screw 153. To adjust the height of the exhaust filter and associated filter heater 134, the user rotates the knob 151. In particular, the user rotates the knob 151 in a first direction (e.g., in a clockwise direction), causing the lead screw 153 to also rotate in the first direction, which in turn causes the back plate 154 to move upwardly along the channel due to its threaded engagement with the lead screw 153. Similarly, by rotating the knob 151 in a second direction (e.g., in a counter-clockwise direction), the back plate 154 moves downwardly along the channel. In this way, the user can adjust the height of the exhaust filter and associated filter heater 134 through rotation of the knob 151.​

[0033] While the above embodiments illustrate height adjustment mechanisms for components having specific geometries / designs, the present invention is not so limited. For example, the T-shaped track may have other configurations (e.g., having a generally plate-like shape, a rod-like shape, etc.) as long as the track can be attached to the frame of the external vessel. Additionally, the length of the track may vary based on the specific application (i.e., the length required for height adjustment). According to one embodiment, the length of the tracks 143, 152 is approximately 50-200 mm, and in a preferred embodiment, the length is approximately 80 mm.

[0034] While two embodiments of height adjustment mechanisms 140, 150 have been described above, the present invention is not so limited, and other variations are within the scope of the present invention. For example, the height adjustment mechanism may include an array of hooks, ledges, or protrusions located at various heights along the track, with the attachment plate 135 including corresponding hooks or attachment points, such that the attachment plate 135 can be hung or otherwise attached to the track at various heights. Still further, the backplate 135 and the track may each be made of or otherwise include at least one magnet or ferromagnetic material, such that the two are magnetically attracted to each other. In this way, the backplate and track can be magnetically coupled at various heights along the track.

[0035] According to any embodiment of the present invention, the height adjustment of the exhaust filter and associated filter heater 134 can be automated. For example, a motor can be attached to knob 151 (or mounted directly to lead screw 153) and utilized to rotate knob 151 in the desired direction to move the exhaust filter and associated filter heater 134 up and down along track 155. Additionally, activation of the motor can be automated based on a feedback loop. For example, and as discussed above, when the tubing attached to the exhaust filter kinks, pressure builds within the single-use bag. This pressure increase can be measured by a pressure sensor within the single-use bag, and when the pressure exceeds a threshold, a signal can be generated, causing activation of the motor, which in turn rotates knob 151 (or lead screw 153) and raises the exhaust filter and associated filter heater 134. Additionally, the height of the top surface of the single-use bag may be monitored, for example, by means of an optical sensor, camera, etc., and when the top surface increases in height by a predetermined amount, a signal may be generated causing activation of a motor to raise the exhaust filter and associated filter heater 134.

[0036] Figure 5 A and Figure 5B shows the operation of the height adjustment mechanism 140, 150 to straighten the at least one tube connecting to the exhaust filter. As discussed above, as cell culture is occurring within the single-use bag 104, gases and fluids are added to the bag to facilitate the culture process. At various times during this process, the single-use bag 104 can become over-aerated. When such over-aeration occurs, the distance between the top surface of the single-use bag 104 and the bottom of the exhaust filter decreases, which causes the tube 106 fluidly connecting the bag to the filter to bend. If the over-aeration is of sufficient amount, the tube 106 will bend to the extent that a kink or blockage 108 is created in the tube 106 (see, e.g. Figure 5 A). This causes pressure to build up within the single-use bag 104, compromising the integrity of the bag. The present invention advantageously allows the user to relieve the kink or otherwise prevent the blockage by raising the height of the exhaust filter and associated filter heater (see, e.g. Figure 5 B). In other words, by raising the exhaust filter and associated filter heater 134 (see the arrow shown in Figure 5 B), the tube connecting the single-use bag to the exhaust filter is straightened via the presently disclosed height adjustment mechanism, thereby ensuring that gases flow outward from the bioreactor system 10 at the proper rate and preventing over-pressurization of the system.

[0037] It is noted that the above description describes a height adjustment mechanism to adjust the height of the exhaust filter and associated filter heater. However, the present invention is not limited to adjustment of such components, and the presently described height adjustment mechanism can be implemented to adjust the height of any component requiring adjustment of the bioreactor system.

[0038] As used herein, an element or step recited in the singular and preceded with the word "a" or "an" should be understood as not excluding plural of said elements or steps, unless explicitly stated that "only one" of them is to be incorporated. Further, an element preceded by the words "one or more" should be understood as possibly, but not necessarily comprising more than one of this element. Furthermore, to the extent that "comprising" is used in the description, it is always intended that applications include the equivalents of that which is claimed, as well as those items which do not materially affect the operation and use of the applications.

[0039] This written description uses examples to disclose several embodiments of the application (including the best mode), and also to enable one of ordinary skill in the art to practice embodiments of the application, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the application is defined by the claims, and can include other examples that occur to those of ordinary skill in the art. Such other examples are intended to fall within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.

Claims

1. A method for adjusting the height of an exhaust filter and an associated filter heater, comprising: attaching the exhaust filter and associated filter heater to a height adjustment mechanism; attaching the height adjustment mechanism to a bioreactor vessel; fluidly connecting the exhaust filter to a single-use bioreactor bag located within the bioreactor vessel via at least one tube; and The height of the exhaust filter and associated filter heater is adjusted relative to the top surface of the single-use bioreactor bag.

2. The method according to claim 1, further comprising: The single-use bioreactor bag is inflated, wherein the adjusting occurs after the single-use bioreactor bag is inflated.

3. The method according to claim 2, wherein: The distance between the exhaust filter and associated filter heater and the top surface of the single-use bioreactor bag is increased, causing the at least one tube to straighten, thereby alleviating overpressure generated in the single-use bioreactor bag due to kinking of the at least one tube.

4. The method according to any one of claims 1 to 3, wherein: The height adjustment mechanism comprises: At least one track, Wherein the adjusting comprises sliding the exhaust filter and associated filter heater along the track.

5. The method according to claim 4, wherein The height adjustment mechanism further comprises: at least one clamp; and at least one plunger, wherein sliding the exhaust filter and associated filter heater along the track comprises: rotating the plunger in a first direction such that the plunger is unlocked from the track, and The exhaust filter and associated filter heater are moved along the track.

6. The method according to claim 5, further comprising: After the exhaust filter and associated filter heater have moved along the track, the plunger is rotated in a second direction to lock the plunger within the slot of the track.

7. The method according to claim 4, wherein The height adjustment mechanism further comprises: a lead screw positioned within the channel of the at least one track; and A knob is located on the first end of the lead screw, wherein sliding the exhaust filter and associated filter heater along the track includes rotating the knob.

8. A method according to any one of the preceding claims, wherein The height of the exhaust filter and associated filter heater relative to the top surface of the single-use bioreactor bag is automatically adjusted based on the height of the top surface of the single-use bioreactor bag or the sensed pressure within the single-use bioreactor bag.

9. The method according to claim 8, wherein Automatically adjusting includes activating a motor when the sensed pressure exceeds a threshold.

10. A bioreactor system comprising: bioreactor vessels; exhaust filters and associated filter heaters; as well as a height adjustment mechanism connected to the exhaust filter and associated filter heater and the bioreactor vessel; wherein the exhaust filter is fluidly connected to a single-use bioreactor bag located within the bioreactor vessel via at least one tube, and Wherein the height adjustment mechanism adjusts the height of the exhaust filter and associated filter heater relative to the top surface of the single-use bioreactor bag.

11. The system according to claim 10, wherein: The height adjustment mechanism comprises: At least one track, Wherein the height of the exhaust filter and associated filter heater is adjusted by sliding along the at least one track.

12. The system according to claim 11, wherein The height adjustment mechanism further comprises: at least one clamp; and at least one plunger, wherein rotation of the plunger in a first direction unlocks the plunger from the track such that the exhaust filter and associated filter heater may travel along the track.

13. The system according to claim 12, wherein: Rotation of the plunger in a second direction locks the plunger within the slot in the track such that the exhaust filter and associated filter heater cannot move along the track.

14. The system according to claim 10, wherein: The height adjustment mechanism further comprises: a lead screw positioned within the channel of the at least one track; and A knob is located on the first end of the lead screw, wherein the height of the exhaust filter and associated filter heater is adjusted by rotating the knob.

15. The system of claim 14, further comprising: at least one sensor configured to determine the height of the top surface or the pressure sensed within the single-use bioreactor bag; as well as motor, Wherein, when the sensed pressure or the height of the top surface exceeds a threshold, the height of the exhaust filter and associated filter heater is automatically adjusted by activating the motor.

Images