Bioprocess cart

Abstract

A bioprocess cart (1) has a mobile chassis formed by a support frame (2) mounted on castors (3). A first or upper bioreactor bag holder (5) and a second or lower bioreactor bag holder (6) are mounted on the support frame (2) on an upper platform (7) and a lower platform (8) respectively of the support frame (2). Each bioreactor bag holder (5, 6) is mounted by associated load cells (9) on the associated platform (7, 8). Display monitors (10) for displaying the weight of contents of the bag holders (5, 6) are mounted at one end of the cart (1).

Description

[0001] “Bioprocess Cart”

[0002] Introduction

[0003] This invention relates to a mobile bioprocess cart for flexible and selective use with bioprocess systems.

[0004] Summary of the Invention

[0005] According to the invention, there is provided a mobile cart for use with a bioprocessing system, comprising a mobile chassis, at least two bioreactor bag holders mounted on the chassis for reception of bioreactor bags of different volumes, each bag holder having an associated weighing apparatus for weighing the contents of a bag mounted on the bag holder.

[0006] In another embodiment, bag holders for reception of bioreactor bags of different volumes are provided.

[0007] In another embodiment, each weighing apparatus is connected to a display monitor mounted on the cart.

[0008] In another embodiment, the weighing apparatus is a load cell.

[0009] In another embodiment, the mobile chassis comprises a support frame mounted on castors, the support frame having an upper platform and a lower platform which are vertically spaced-apart on the support frame, an upper bioreactor bag holder mounted by associated upper bioreactor bag holder load cells on the upper platform and a lower bioreactor bag holder mounted by associated lower bioreactor bag holder load cells on the lower platform, said load cells being connected to associated display monitors mounted on the support frame for displaying the weight of contents within each bioreactor bag holder, each bioreactor bag holder having an outlet port at a bottom of the bioreactor bag holder for reception and through passage of an outlet of a bioreactor bag when the bioreactor bag is mounted within the bioreactor bag holder.

[0010] In another embodiment, the support frame has an outwardly projecting work table at aside of the support frame.

[0011] In another embodiment, a rail is mounted on the support frame below the work table and a pair of spaced-apart clamps are mounted on the rail for releasably mounting an inline filter on the cart in use.

[0012] In another embodiment, a pair of spaced-apart hooks for power cable storage are mounted on the support frame below the work table.

[0013] In another embodiment, the cart has levelling apparatus.

[0014] In another embodiment, the levelling apparatus comprises a set of levelling feet mounted on the cart and being movable between a retracted stored position on the cart and an extended position for engagement with a support surface upon which the cart is sitting in use.

[0015] In another embodiment, each of the levelling feet threadedly engages the cart for movement between the stored position and the extended position.

[0016] In another embodiment, the bag holder has a base with upstanding side walls, the base being tapered inwardly and downwardly from the side walls to funnel towards an outlet port at a bottom of the base.

[0017] In another embodiment, a folded lip is provided at a top of each side wall.

[0018] In another embodiment, an access opening is provided in a front side wall of the bag holder.

[0019] In another embodiment, the access opening is closed by a hinged door mounted on the front side wall of the bag holder.

[0020] In another embodiment, one or more level viewing slots are provided in the front side wall of the bag holder.

[0021] In another embodiment, two bag holders are nestable together, comprising an outer bag holder and an inner demountable bag holder which is nestable with the outer bag holder.In another embodiment, the inner demountable bag holder has a hanger lip projecting outwardly at a top of the front side wall of the inner bag holder which is engagable with a top of the front side wall of the outer bag holder to hang the inner bag holder on the front side wall of the outer bag holder, within the outer bag holder.

[0022] In another embodiment, a demountable bioreactor bag holder is provided for demountable nesting within the upper bioreactor bag holder, the demountable bioreactor bag holder has a hanger rail projecting outwardly at a top of a side wall of the demountable bag holder for engagement with and suspension from a top of a side wall of the upper bioreactor bag holder, the demountable bioreactor bag holder having an outlet port in a base of the demountable bioreactor bag holder which aligns with the outlet port of the upper bioreactor bag holder when the demountable bioreactor bag holder is mounted within the upper bioreactor bag holder.

[0023] One or more advantages may be offered by at least one embodiment of the disclosure in addition to or instead of other advantage(s) either explicitly or implicitly provided herein. In one aspect, the disclosure may be durable, corrosion-resistant, and easy to clean when comprising, by way of the non-limiting example, 304-grade stainless steel. In another aspect, the disclosure may allow customizable configurations with single or multi-tier setups tailored to users’ needs. In another aspect, the disclosure may be compatible, and therefore work with, off-the-shelf BioProcess Containers (BPC). In another aspect, the disclosure may allow multivolume capacity wherein each holder may utilize, by way of non-limiting examples, 50 Liter, 100 Liter, and 200 Liter BPCs. In another aspect, the disclosure may include smooth surfaces which are easy to clean and / or reduce contamination risk and wherein surface p-in Ra can be certified to the user’s specific requirements. In another aspect, the disclosure may include rounded corners which remove risk of damage to the BPCs during handling. In another aspect, the disclosure may include heavy-duty casters for easy movement between areas. In another aspect, the disclosure may include integrated load cells for accurate weight measurement and process control. In another aspect, the disclosure may allow force calibration to ensure precise pressure monitoring. In another aspect, the disclosure may include port access for convenient top and bottom access for liquid handling. In another aspect, the disclosure may permit for customization options including, but not limited to, temperature transmitters and filter brackets. In another aspect, the disclosure mayinclude be durable and GMP-compatible so as to be designed for biopharma processes. In another aspect, the disclosure may permit for multi-solution handling for managing media, buffers, and additives. In another aspect, the disclosure may permit for supply chain flexibility by way of compatibility with multiple off-the-shelf bag suppliers globally. In another aspect, the disclosure may be easy to clean so as to reduce contamination risks. In another aspect, the disclosure may include enhanced mobility so as to streamline workflow. In another aspect, the disclosure may include accurate monitoring by way of load cells and temperature transmitters for precise control. In another aspect, the disclosure may permit sustainability by way of zero water usage during operation.

[0024] Brief Description of the Drawings

[0025] The invention will be more clearly understood by the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which:

[0026] Fig. 1 is a perspective view of a mobile bioprocess cart according to the invention;

[0027] Fig. 2 is a front elevational view of the bioprocess cart;

[0028] Fig. 3 is a right side elevational view of the bioprocess cart;

[0029] Fig. 4 is a plan view of the bioprocess cart;

[0030] Fig. 5 is a detail perspective view showing portion of the bioprocess cart, indicated as detail A in Fig. 1;

[0031] Fig. 6 is a perspective view of a bioreactor bag holder forming portion of the bioprocess cart;

[0032] Fig. 7 is a front elevational view of the bag holder shown in Fig. 6;

[0033] Fig. 8 is a plan view of the bag holder shown in Fig. 6;Fig. 9 is a detail perspective view showing portion of the bag holder of Fig. 6, indicated as detail D in Fig. 6;

[0034] Fig. 10 is a perspective view of another bag holder forming portion of the bioprocess cart;

[0035] Fig; 11 is a front elevational view of the bag holder of Fig. 10; and

[0036] Fig. 12 is a plan view of the bag holder of Fig. 10.

[0037] Detailed

[0038]

[0039] of the Preferred Embodiments

[0040] Reference will now be made in detail to several embodiments of the disclosure that are illustrated in the accompanying drawings. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts.

[0041] While features of various embodiments are separately described herein, it is understood that such features may be combinable to support other additional embodiments.

[0042] Components described herein may be composed of one or more suitable materials. Components described herein may be manufactured via methods, processes, and techniques understood in the art, including, but not limited to, machining, molding, forming, or three-dimensional printing.

[0043] The drawing figures are not necessarily drawn to scale, but instead are drawn to provide a better understanding of the components thereof, and are not intended to be limiting in scope, but to provide exemplary illustrations.

[0044] Referring to the drawings, there is illustrated a mobile bioprocess cart according to the invention, indicated generally by the reference numeral 1. The bioprocess cart 1 has a mobile chassis formed by a support frame 2 mounted on castors 3. A first or upper bioreactor bag holder 5 and a second or lower bioreactor bag holder 6 are mounted on the support frame 2 on an upper platform 7 and a lower platform 8 respectively of the support frame 2. Each bioreactor bag holder 5, 6 is mounted by associated load cells 9 on the associated platform 7, 8. Display monitors 10 fordisplaying the weight of contents of the bag holders 5, 6 are mounted at one end of the cart 1.

[0045] The support frame 2 has four upright corner posts 12 which support the upper platform 7 and lower platform 8 therebetween and vertically spaced-apart. Castors 3 project downwardly from an underside of the lower platform 8. Each castor wheel may be lockable.

[0046] An adjustable levelling foot 14 is mounted at a bottom of each corner post 12 and each foot 14 comprises a ground-engaging disc 15 mounted at a bottom of a threaded rod 16 which screws up into the associated corner post 12 on which the foot 14 is mounted. Screwing each rod 16 into or out of the associated corner post 12 facilitates levelling and stabilising of the cart 1 when the cart 1 is stopped.

[0047] A handrail 17 is mounted between corner posts 12 at one side of the cart 1. At an opposite side of the cart 1, the display monitors 10 are mounted on the corner posts 12 above a work table 18 which projects outwardly from the corner posts 12. The work table 18 can conveniently be used to support a fluid transfer pump such as a peristaltic pump, for example. Below the work table 18, a rail 19 extends between the corner posts 12. Upon the rail 19 is mounted a pair of spaced-apart clamps 20 for releasably mounting an inline filter on the cart 1. A pair of spaced-apart hooks 21 for power cable storage is provided on one of the corner posts 12.

[0048] The upper bioreactor bag holder 5 has a base 24 with upstanding side walls comprising a front wall 25, rear wall 26 and end walls 27 extending between the front wall 25 and rear wall 26. The base 24 is tapered inwardly and downwardly from the side walls 25, 26, 27 to funnel towards an outlet port 28 at a bottom of the base 24. It will be noted that an out-turned folded lip 29 at an upper end of each side wall 25, 26, 27 increases the stiffness of the side wall 25, 26, 27.

[0049] A 50 litre, 100 litre or a 200 litre bioreactor bag can be mounted within the upper bag holder 5 with an outlet of the bioreactor bag positioned and aligned with the outlet port 28 and extending through the outlet port 28. Corner brackets 36 with through holes 37 at a top of the upper bioreactor bag holder 5 can be used if desired to additionally support the bioreactor bag within the upper bioreactor bag holder 5.An access opening 30 is provided in the front wall 25 which is closed by a door 31 mounted by hinges 32 on the front wall 25 at one side of the access opening 30 and having spring-loaded latches 33 to releasably secure the door 31 in the closed position. A pair of elongate vertical level viewing slots 34 extend upwardly on the front wall 25 at one side of the door 31 for viewing the level of liquid in a bioreactor bag housed within the upper bioreactor bag holder 5 in use.

[0050] Referring in particular to Fig. 6 to Fig. 9, the lower bioreactor bag holder 6 is shown. This is largely similar to the upper bioreactor bag holder 5. The lower bioreactor bag holder 6 has a base 40 with upstanding side walls comprising a front wall 41, rear wall 42 and end walls 43 extending between the front wall 41 and the rear wall 42. The base 40 is tapered inwardly and downwardly from the side walls 41, 42, 43 to funnel towards an outlet port 44 at a bottom of the base 40. Out-turned folded lips 45 at an upper end of each side wall 41 , 42, 43 provide additional strength and stiffness to the side walls 41, 42, 43. A door 50 is provided in the front wall 41 closing an access opening therein and mounted on hinges 51 and closed by spring loaded door latches 52, 53. Elongate vertical viewing slots 55 are provided in the front wall 41 at one side of the door 50 for monitoring the level of liquid in a bioreactor bag mounted within the lower bioreactor bag holder 6.

[0051] A 50 litre, 100 litre or a 200 litre bioreactor bag can be mounted within the lower bioreactor bag holder 6 with an outlet of the bioreactor bag positioned and aligned with the outlet port 44 and extending through the outlet port 44.

[0052] Referring in particular to Fig. 10 to Fig. 12, there is shown a third or inner demountable bioreactor bag holder 60 which is demountably nestable within the upper bioreactor bag holder 5. The inner bioreactor bag holder 60 comprises a rectangular base 61 with upstanding side walls comprising a front wall 62, rear wall 63 and end walls 64 extending between the front wall 62 and the rear wall 63. A viewing window and access opening 66 is provided in the front wall 62. This access opening 66 can be used to insert a bioreactor bag into the inner bioreactor bag holder 60 and subsequently remove the bioreactor bag. It can also be used to view the contents of the bioreactor bag during use to monitor fluid level. An outlet port 67 in the base 61 aligns with the outlet port 28 in the upper bag holder 5. A hanger rail 68 projects outwardly at a top of the front wall 62 to allow the inner bag holder 60 to be suspended on the front wall 25 of the upper bioreactor bag holder 5 nesting withinthe upper bioreactor bag holder 5, as shown in Fig. 1. When nested within the upper bag holder 5, the inner bag holder 60 is for supporting a 50 litre bioreactor bag.

[0053] The bioprocess cart 1 of the invention is preferably constructed from stainless steel.

[0054] In use, the cart 1 can be wheeled to a desired position of use in a bioprocess system as required. The castors 3 are locked and the levelling feet 12 adjusted as necessary to level and stabilise the cart 1. Bioreactor bags mounted in one or two of the bioreactor bag holders 5,6,60 are connected into the bioprocess system and can be used to transfer fluids between the bioprocess system and the bioreactor bags, either delivering fluid into the bioprocess system or extracting fluid from the bioprocess system. A hose (not shown) is connected directly to an outlet of the bioreactor bag, said hose passing through the outlet port 28, 44, 67 of the bioreactor bag holder 5, 6, 60, being led through a peristaltic pump on the work table 18 and connected to the bioprocess system.

[0055] Advantageously, the mobile bioprocess cart 1 of the invention provides a multifunctional, sustainable, flexible, reliable and easy to use mobile solution for executing multiple single-use unit operations in upstream and downstream applications while maintaining the integrity and sterility of process liquids for aseptic storage, transport, dispensing and sampling with faster turnaround. For single use bioprocessing liquid handling needs, the accurate combined functions of the bioprocess cart 1 make it an ideal choice for lowering cost of ownership for bioprocess equipment overall and improving workflow by eliminating equipment with limited functionality.

[0056] The bioprocess cart 1 also provides weighing capability with waterless calibration for ROI and environmental responsibility once location is secured with stabilizers 14 for compliance. Further, use of three different size bags 50L, 100L or 200L is possible, for accurate fluid volume requirements, lowering plastic and solutions waste and accommodating off-the-shelf bags.

[0057] It will be noted also that the bioprocess cart 1 provides dual bioreactor bag holders 5,6,60 which provides the capability to handle more than one process fluid if necessary or desirable. Plug and play Precia Molen load cells 9 with display monitors 10 give accurate fill-volume status for each bioreactor bag holder 5,6,60 and isconfigured for force calibration for sustainable use. No water is used for calibration. Weighing capability can be deployed anywhere on any flat surface once stabilized and can be validated with traceable waterless calibration for FDA compliance. Two on-board filter brackets 20 accept 10 to 30 inch capsule filters and together with an integrated transfer pump can execute a host of upstream and downstream processes from seed vessel support, perfusion, production vessels additions, harvesting, clarification / filtration, pooling, sampling and transport. The bioprocess cart 1 performs its bioprocess functions and can be easily wheeled out eliminating the need for permanent floor space. Power panel plugs in and provides additional remote outlet for additional equipment.

[0058] For more functionality and integration, the bioprocess cart 1 may include jacketed temperature control with on-board TCU (temperature control unit), recirculation pump, additional filter brackets, tubing brackets and sensors for temperature, pH or conductivity with transmitters outputs, flowmeter / accumulator.

[0059] Key Benefits:

[0060] • 304-Grade Stainless Steel: Durable, corrosion-resistant,

[0061] and easy to clean.

[0062] • Customizable Configurations: Single or multi-tier setups

[0063] tailored to users needs.

[0064] • BPC Compatibility: Works with off-the-shelf BioProcess

[0065] Containers (BPCs).

[0066] • Multivolume capacity: Each holder can utilize 50L, 100L

[0067] and 200L BPCs.

[0068] • Smooth Surfaces: Easy to clean, reducing contamination

[0069] risk; surface p-in Ra can be certified to the users specific

[0070] requirements.

[0071] • Rounded Corners: All edges and corners are rounded to

[0072] remove risk of damage to the BPCs during handling.

[0073] • Heavy-Duty Casters: For easy movement between areas.

[0074] • Integrated Load Cells: For accurate weight measurement

[0075] and process control.

[0076] • Force Calibration: Ensures precise pressure monitoring.

[0077] • Port Access: Convenient top and bottom access for liquid

[0078] handling.• Customization Options: Includes temperature

[0079] transmitters, filter brackets, and more.

[0080] Benefits:

[0081] • Durable & GMP-Compatible: Designed for biopharma

[0082] processes.

[0083] • Multi-Solution Handling: Manages media, buffers, and

[0084] additives.

[0085] • Supply Chain Flexibility: Compatible with multiple off-the-shelf

[0086] bag suppliers globally.

[0087] • Easy to Clean: Reduces contamination risks.

[0088] • Enhanced Mobility: Streamlines workflow.

[0089] • Accurate Monitoring: Load cells and temperature

[0090] transmitters for precise control.

[0091] • Sustainable: Zero water usage during operation.

[0092] Applications:

[0093] • Storing and Handling process liquids

[0094] • Feeding and Perfusion

[0095] • Buffer and Additive management

[0096] • Harvesting and Clarification

[0097] • Viral Inactivation

[0098] • Filtration and Transfer

[0099] One or more embodiments of the disclosure may facilitate application(s) including but not limited to storing and handling process liquids, feeding and perfusion, buffer and additive management, harvesting and clarification, viral inactivation, and filtration and transfer.

[0100] While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are shown in the drawings and are described in detail herein. It should be understood, however, there is no intention to limit the disclosure to the specific embodiments disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, combinations, and equivalents falling into the spirit and scope of the disclosure.The terms “comprise” and “include”, and any variations thereof required for grammatical reasons, are to be considered as interchangeable and accorded the widest possible interpretation.

[0101] The invention is not limited to the embodiments hereinbefore described but may be varied in both construction and detail within the scope of the appended claims.

[0102] I

Claims

CLAIMS1. A mobile bioprocess cart (1 ) for use with a bioprocess system, comprising:a mobile chassis (2),the mobile chassis comprising a support frame (2) mounted on castors (3),the support frame (2) having an upper platform (7) and a lower platform (8) which are vertically spaced-apart on the support frame (2),an upper bioreactor bag holder (5) mounted by associated upper bioreactor bag holder load cells (9) on the upper platform (7) and a lower bioreactor bag holder (6) mounted by associated lower bioreactor bag holder load cells (9) on the lower platform (8), said load cells (9) being connected to associated display monitors (10) mounted on the support frame (2) for displaying the weight of contents within each bioreactor bag holder (5, 6),each bioreactor bag holder (5, 6) having an outlet port (28, 44) at a bottom of the bioreactor bag holder (5, 6) for reception and through passage of an outlet of a bioreactor bag when the bioreactor bag is mounted within the bioreactor bag holder (5, 6).

2. The mobile bioprocess cart (1 ) as claimed in claim 1 , wherein the support frame (2) has an outwardly projecting work table (18) at a side of the support frame (2).

3. The mobile bioprocess cart (1) as claimed in claim 2, wherein a rail (19) is mounted on the support frame (2) below the work table (18) and a pair of spaced-apart clamps (20) are mounted on the rail (19) for releasably mounting an inline filter on the bioprocess cart (1) in use.

4. The mobile bioprocess cart (1) as claimed in claim 1 or claim 2, wherein a pair of spaced-apart hooks (21 ) for power cable storage are mounted on the support frame (2) below the work table (18).

5. The mobile bioprocess cart (1) as claimed in any one of the preceding claims, wherein bag holders for reception of bioreactor bags of different volumes are provided.

6. The mobile bioprocess cart (1) as claimed in any preceding claim, wherein the cart has levelling apparatus (14).

7. The mobile bioprocess cart (1) as claimed in claim 6, wherein the levelling apparatus comprises a set of levelling feet (14) mounted on the cart (1) and being movable between a retracted stored position on the cart (1) and an extended position for engagement with a support surface upon which the cart (1) is sitting in use.

8. The mobile bioprocess cart (1) as claimed in claim 7, wherein each of the levelling feet (14) threadedly engages the cart (1) for movement between the stored position and the extended position.

9. The mobile bioprocess cart (1) as claimed in any preceding claim, wherein each bioprocess bag holder (5, 6) has a base (24, 40) with upstanding side walls (25, 26, 27, 41, 42, 43), the base (24, 40) being tapered inwardly and downwardly from the side walls (25, 26, 27, 41 , 42, 43) to funnel towards the outlet port (28, 44) at a bottom of the base (24, 40).

10. The mobile bioprocess cart (1) as claimed in claim 9, wherein a folded lip (29, 45) is provided at a top of each side wall (25, 26, 27, 41, 42, 43) of the bag holder (5, 6).

11. The mobile bioprocess cart (1) as claimed in claim 9 or claim 10, wherein an access opening (30) is provided in a front side wall (25, 41) of the bag holder (5, 6).

12. The mobile bioprocess cart (1) as claimed in claim 11, wherein the access opening (30) is closed by a hinged door (31, 50) mounted on the front side wall (25, 41) of the bag holder (5, 6).

13. The mobile bioprocess cart (1 ) as claimed in any one of claims 9 to 12, wherein one or more level viewing slots (34, 55) are provided in the front side wall (25, 41) of the bag holder (5, 6).

14. The mobile bioprocess cart (1) as claimed in any one of the preceding claims, wherein a demountable bioreactor bag holder (60) is provided for demountable nesting within the upper bioreactor bag holder (5), the demountable bioreactor bag holder (60) having a hanger rail (68) projecting outwardly at a top of a side wall (62) of the demountable bag holder (60) for engagement with and suspension from a top of a side wall (25) of the upper bioreactor bag holder (5), the demountable bioreactor bag holder (60) having an outlet port (67) in a base (61) of the demountable bioreactor bag holder (60) which aligns with the outlet port (28) of the upper bag holder (5) when the demountable bag holder (60) is mounted within the upper bioreactor bag holder (5).

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