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Title:
CHROMATOGRAPHY COLUMN STAND
Document Type and Number:
WIPO Patent Application WO/2024/081766
Kind Code:
A1
Abstract:
A chromatography column stand includes a floor portion, a wall portion, an internal volume, and a base portion. The floor portion supports a chromatography column. The wall portion extends from a first side of the floor portion around a periphery of the floor portion, and has an internal surface. The internal volume is defined by the internal surface of the wall portion and the first side of the floor portion. The base portion extends from an external surface of the stand. The wall portion and the base portion maintain the chromatography column in an upright position when the chromatography column is disposed within the internal volume.

Inventors:
HOLTZ BAILEY (US)
Application Number:
PCT/US2023/076660
Publication Date:
April 18, 2024
Filing Date:
October 12, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
ALDEVRON L L C (US)
International Classes:
G01N30/60; B01D15/22
Domestic Patent References:
WO2022167869A22022-08-11
Foreign References:
CN106984066A2017-07-28
US10391422B22019-08-27
US20160152660A12016-06-02
Attorney, Agent or Firm:
HARRIGAN, Jeffrey, C. et al. (US)
Download PDF:
Claims:
CLAIMS

1. A chromatography column stand, comprising: a floor portion configured to support a chromatography column; a wall portion extending from a first side of the floor portion around a periphery of the floor portion, the wall portion having an internal surface; an internal volume defined by the internal surface of the wall portion and the first side of the floor portion; and a base portion extending from an external surface of the chromatography column stand, wherein the wall portion and the base portion are configured to maintain an upright position of the chromatography column when the chromatography column is disposed within the internal volume.

2. The chromatography column stand of claim 1, wherein the floor portion is further configured to reduce a risk of damage to the chromatography column when the chromatography column is supported by the floor portion.

3. The chromatography column stand of any one of the preceding claims, wherein the external surface is an external surface of the wall portion and/or the floor portion.

4. The chromatography column stand of any one of the preceding claims, wherein the floor portion comprises a plurality of floor elements extending across a first end of the internal volume.

5. The chromatography column stand of any one of the preceding claims, wherein the floor portion comprises a structural material and a cushioning material.

6. The chromatography column stand of any one of the preceding claims, wherein the wall portion comprises an annular cylinder.

7. The chromatography column stand of any one of the preceding claims, wherein the base portion comprises an annular disc having a diameter greater than a diameter of the wall portion.

8. The chromatography column stand of any one of the preceding claims, wherein the base portion comprises a plurality of braces.

9. The chromatography column stand of claim 8, wherein each brace of the plurality of braces comprises an angle bracket.

10. The chromatography column stand of any one of the preceding claims, wherein the base portion comprises three or four legs, the legs being spaced at equal intervals around a periphery of the stand.

11. The chromatography column stand of any one of the preceding claims, wherein the wall portion is formed from polyvinyl chloride (PVC), polypropylene, acrylonitrile butadiene styrene (ABS), polylactic acid (PL A), polyethylene terephthalate (PET), polycarbonate (PC), or polyether ether ketone (PEEK).

12. The chromatography column stand of any one of the preceding claims, wherein the internal volume is sized and shaped to receive a chromatography column having an inner diameter of about 10 centimeters (cm), about 14 cm, or about 20 cm.

13. The chromatography column stand of any one of the preceding claims, further comprising a removable sleeve insertable into the internal volume.

14. The chromatography column stand of any one of the preceding claims, wherein the removable sleeve is sized and shaped to receive a chromatography column having an inner diameter of about 10 cm or about 14 cm.

15. The chromatography column stand of any one of the preceding claims, wherein a height of the wall portion is about 20 cm.

16. The chromatography column stand of any one of the preceding claims, wherein the wall portion and the base portion are configured to maintain the upright position of the chromatography column having a height of about 50 cm.

17. The chromatography column stand of any one of the preceding claims, wherein the wall portion and the base portion are configured to maintain the upright position of the chromatography column having an inner diameter of about 10 cm, about 14 cm, or about 20 cm.

18. A method of performing maintenance on a chromatography apparatus, the method comprising: removing a chromatography column from the chromatography apparatus; placing the chromatography column in a chromatography column stand, the chromatography column stand comprising: a floor portion, a wall portion extending from a first side of the floor portion around a periphery of the floor portion, the wall portion having an internal surface, an internal volume defined by the internal surface of the wall portion and the first side of the floor portion, and a base portion extending from an external surface of the chromatography column stand; performing one or more maintenance operations on the chromatography apparatus; removing the chromatography column from the chromatography column stand; and replacing the chromatography column in the chromatography apparatus.

19. The method of claim 18, further comprising placing a removable sleeve in the internal volume of the chromatography column stand, wherein placing the chromatography column in the chromatography column stand comprises placing the chromatography column in the annular sleeve.

20. The method of claim 18, further comprising placing the chromatography column into a removable sleeve, wherein placing the chromatography column in the chromatography column stand comprises placing the chromatography column and the annular sleeve together into the internal volume of the chromatography column stand.

21. The method of any of claims 18-20, wherein placing the chromatography column in the chromatography column stand comprises standing the chromatography column in an upright position within the internal volume of the chromatography column.

22. The method of any of claims 18-21, wherein placing the chromatography column in the chromatography column stand comprises reducing a risk of damage to the chromatography column.

23. The method of claim 22, wherein reducing a risk of damage to the chromatography column comprises placing the chromatography column on a cushioned portion of the floor portion and/or maintaining an upright position of the chromatography column within the internal volume.

24. The method of any of claims 18-23, wherein removing the chromatography column from the chromatography apparatus comprises removing the chromatography column having a height of about 50 centimeters (cm).

25. The method of any of claims 18-24, wherein removing the chromatography column from the chromatography apparatus comprises removing the chromatography column having an inner diameter of about 10 cm, about 14 cm, or about 20 cm.

Description:
CHROMATOGRAPHY COLUMN STAND

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application Serial No.: 63/415,766, filed October 13, 2022, and entitled “CHROMATOGRAPHY COLUMN STAND,” which is incorporated by reference in its entirety for all purposes.

FIELD

[0002] Disclosed embodiments are related to chromatography column stands.

BACKGROUND

[0003] Chromatography is a method of separating the components of a fluid mixture. Chromatography is widely used for processing and analyzing mixtures of molecules, such as biological molecules, including proteins and nucleic acids, and chemical molecules. Several types of chromatography methods are known, including column chromatography. Column chromatography may require a fluid mixture of molecules (referred to as a mobile phase) to be passed through a solid material within a column, tube, or similar vessel (the solid material being referred to as a stationary phase). The components of the mobile phase may pass through the stationary phase at different rates, causing the mixture of molecules to separate as the mixture passes through the column.

SUMMARY

[0004] In some embodiments, a chromatography column stand may comprise a floor portion, a wall portion, an internal volume, and a base portion. The floor portion may be configured to support a chromatography column. The wall portion may extend from a first side of the floor portion around a periphery of the floor portion, and the wall portion may have an internal surface. The internal volume may be defined by the internal surface of the wall portion and the first side of the floor portion. The base portion may extend from an external surface of the chromatography column stand. The wall portion and the base portion may be configured to maintain an upright position of the chromatography column when the chromatography column is disposed within the internal volume. [0005] In other embodiments, a method of performing maintenance on a chromatography apparatus may comprise removing a chromatography column from the chromatography apparatus and placing the chromatography column in a chromatography column stand. In some embodiments, the chromatography column stand may comprise a floor portion, a wall portion, an internal volume, and a base portion. The wall portion may extend from a first side of the floor portion around a periphery of the floor portion, and the wall portion may have an internal surface. The internal volume may be defined by the internal surface of the wall portion. The base portion may extend from an external surface of the chromatography column stand. In some embodiments, the method may further comprise performing one or more maintenance operations on the chromatography apparatus, removing the chromatography column from the chromatography column stand, and replacing the chromatography column in the chromatography apparatus.

[0006] It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various nonlimiting embodiments when considered in conjunction with the accompanying figures.

BRIEF DESCRIPTION OF DRAWINGS

[0007] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0008] Fig. l is a perspective view of one embodiment of a chromatography column stand having two bands securing three braces to the stand;

[0009] Fig. 2 is a perspective view of another embodiment of a chromatography column stand having fasteners securing three braces to the stand;

[0010] Fig. 3A is a cross-sectional view of a chromatography column stand according to a further embodiment;

[0011] Fig. 3B is a cross-sectional view of the chromatography column stand of Fig. 3 A, including a removable sleeve; [0012] Fig. 4A is a top view of another embodiment of a chromatography column stand having three legs and a plurality of floor elements;

[0013] Fig. 4B is a top view of the chromatography column of Fig. 4A, including a removable sleeve;

[0014] Fig. 5 is a top view of another embodiment of a chromatography column stand having four braces;

[0015] Fig. 6 is a top view of another embodiment of a chromatography column stand having a single brace and a single, grid-shaped floor element;

[0016] Fig. 7 is a top view of a chromatography column stand having six legs and a floor portion comprising a wire mesh according to another embodiment; and [0017] Fig. 8 is a flow chart depicting a method of performing maintenance on a chromatography apparatus using a chromatography column stand according to one embodiment.

DETAILED DESCRIPTION

[0018] As noted above, in some column chromatography processes, a fluid mixture (or mobile phase) may be passed through a column, tube, or other hollow, vessel that is at least partially filled or packed with a solid material (or stationary phase), such as beads or particles. An apparatus or system for performing column chromatography may therefore include one or more chromatography columns for carrying out one or more chromatography processes. Such a chromatography apparatus may need to be at least partially disassembled at various times, for example to perform maintenance or cleaning operations on the apparatus. Disassembly of the apparatus may require removal of the one or more chromatography columns.

[0019] In some applications, a chromatography column may be at least partially constructed from glass or a similar material which may be prone to cracking, chipping, scratching, or other damage if the column is mishandled. Accordingly, removal of a column from an apparatus during maintenance or other disassembly operations may create a risk of damaging the column. Additionally, the risk of damage may be increased in some applications requiring larger or heavier columns. For example, in some applications, a column may have a length or height of about 50 centimeters (cm) or more, an inner diameter of about 20 cm or more, and/or a weight of about 75 pounds or more. Furthermore, because some chromatography processes may be carried out under pressure (i.e., the column may be pressurized internally), even minor damage may render the column inoperable. Therefore, it may be desirable to minimize or reduce the risk of damage to chromatography columns, particularly when the column is removed from a chromatography apparatus during maintenance or disassembly of the apparatus.

[0020] The risk of damage may be slightly reduced through careful handling of the column. For example, the column may be either stood vertically or laid horizontally on a flat surface (e.g., a floor or a table). However, significant risk of damage remains when the column is disposed in either of these orientations. A column which has been stood vertically on the floor may tip over, causing the column to crash onto the floor and break. A column which has been laid horizontally may easily roll across the floor, creating a risk of damage through contact with other objects in the vicinity. In either orientation, the column may further constitute a significant tripping hazard if placed on the floor, creating risk of injury to persons nearby in addition to the risk of damage to the column.

[0021] In view of the above, the inventors have recognized and appreciated the benefits of a chromatography column stand capable of supporting a chromatography column. In some embodiments, the chromatography column stand may reduce a risk of damage to the chromatography column, for example by maintaining or being configured to maintain an upright position of the chromatography column. In some embodiments, the chromatography column stand may reduce or be configured to reduce a risk that the chromatography column will tilt or tip from the upright position.

[0022] In some embodiments, a chromatography column stand may include a floor portion, a wall portion, and an internal volume at least partially defined by the floor portion and the wall portion. The internal volume may be sized and shaped to receive a chromatography column and may be at least partially defined within or defined by the wall portion. The floor portion may define a first end of the internal volume or may be disposed at the first end to prevent a chromatography column disposed within the internal volume from passing through the first end. Accordingly, the floor portion of the chromatography column stand may prevent the chromatography column from contacting a floor or ground on which the chromatography column stand may be disposed. Additionally, the floor portion may be configured to support at least a portion of a weight of the chromatography column. [0023] The chromatography column stand may further include a base portion extending from an external surface of the chromatography column stand, which may be an external surface of the wall portion and/or the floor portion. The base portion may provide stability to the stand and to a chromatography column disposed within the stand. The base portion may comprise one or more braces extending from the chromatography column stand, the braces being sized, proportioned, and/or otherwise configured to maintain an upright position of a chromatography column by preventing the chromatography column stand from tipping or tilting.

[0024] In some applications, it may be desirable for a single chromatography column stand to be configured to accommodate chromatography columns having different dimensions. For example, it may be desirable for a chromatography column stand to accommodate both a first chromatography column having an inner diameter of 20 cm and a second chromatography column having an inner diameter of 10 cm. However, in some embodiments, a wall portion of a chromatography column may be formed as a rigid component that may not be adjustable in size to accommodate chromatography columns having various diameters.

[0025] In view of the above, the inventors have recognized and appreciated the benefits of a chromatography column stand including a removable sleeve that may be inserted into the internal volume of the chromatography column stand. In some embodiments, the removable sleeve may be formed as an annular cylinder. An annular removable sleeve may have an outer diameter which may be the same or substantially the same as an inner diameter of the internal volume of the chromatography column stand, such that the sleeve may be substantially prevented from translating horizontally (i.e., in-plane with a floor or surface on which the stand may be disposed), tipping, and/or tilting within the internal volume. The annular removable sleeve may additionally have an inner diameter that may be smaller than the inner diameter of the wall portion of the chromatography column stand. The inner diameter of the annular removable sleeve may define an internal sleeve volume. The internal sleeve volume may be smaller than the internal volume of the chromatography column stand. Accordingly, insertion of the annular removable sleeve into the internal volume of a chromatography column stand may allow the chromatography column stand to receive, stabilize, and/or maintain an upright position of a chromatography column having a smaller diameter or size than a chromatography column for which the wall portion may be sized or configured.

[0026] Additionally, because some chromatography columns may have a significant weight and may be formed from a fragile material (e.g., glass or borosilicate glass), the weight of the chromatography column may be sufficient to damage the column material if the column is rested on a material that is significantly harder and/or stronger than the column material. In one non -limiting example, a glass chromatography column may weigh around 75 pounds. Such a column may experience chipping or cracking if placed in a chromatography column stand having a floor portion consisting of a hard metal such as steel. Accordingly, inclusion of a compliant or cushioning material (e.g., rubber, polymer, etc.) in the chromatography column stand or a floor portion thereof may reduce the risk of damage associated with the contact between a chromatography column and the stand or the floor portion. However, a floor portion consisting of a cushioning material alone may lack the strength and rigidity desired to support the weight of a chromatography column.

[0027] In view of the above, the inventors have recognized and appreciated the benefits of a chromatography column stand having a floor portion that is configured to reduce a risk of damage to the chromatography column when the chromatography column is supported by the floor portion. For example, in some embodiments, a chromatography column stand may comprise a floor portion which includes both a structural material and a cushioning material. The structural material may be a hard, stiff, or rigid material such as a metal, plastic, ceramic, composite, or other material suitable for supporting at least some of the weight of the chromatography column. The cushioning material may be a rubber, elastomer, polymer, or other material suitable for providing a non-damaging interface between a chromatography column and the chromatography column stand or the structural material. In some embodiments, the floor portion may comprise a structural material with a layer of cushioning material disposed on the structural material.

[0028] Further, in some embodiments, the cushioning material may be removable from the structural material, from the floor portion, or from the chromatography column stand. For example, cushioning material may be provided as a separate component that may be selectively placed on or removed from a structural material. In one non-limiting example, a floor portion may comprise a plurality of rods formed from a structural material. A sheath of cushioning material may be placed on one or more of the rods before a column is placed in the stand, and the sheath may be removed after the column is removed. This arrangement may facilitate maintenance or cleaning of the chromatography column stand and/or the floor portion. It will be appreciated that although removable cushioning material has been described here in the context of a floor portion comprising rods, the removable cushioning material may be employed in any other embodiment as well, as the disclosure is not limited in this regard.

[0029] Additionally, in some applications, a chromatography process or maintenance procedure may require that a chromatography column be filled with water or other fluids. As a result, the chromatography column may be wet when it is removed from the chromatography apparatus. In view of the above, the inventors have recognized and appreciated the benefits of a chromatography column stand comprising one or more materials that are resistant to corrosion, oxidation, rust, or other damage that may result when the chromatography column stand, or a component thereof, is exposed to water or fluids. For example, a layer of cushioning material disposed on a structural material of a floor portion may provide a water- or fluid-resistant characteristic to the structural material, thereby extending the useful life of the floor portion or the chromatography column stand. Additionally or alternatively, the wall portion, base portion, or any other component of the chromatography column stand may be formed from a plastic, composite, or other water- or fluid-resistant material.

[0030] In some embodiments, a chromatography column stand may include a floor portion, a wall portion, an internal volume, and a base portion. The floor portion may be configured to support a chromatography column. In some embodiments, the floor portion may be configured to support the column when the column is disposed in an upright position within the internal volume. In some embodiments, the floor portion may be formed as a solid and substantially planar floor surface extending across a first end of the internal volume. In some embodiments, and in order to facilitate drainage of water or fluids from a chromatography column as described above, the floor portion may include one or more floor elements extending across a portion of the first end to establish a floor plane on which a chromatography column may be supported. The floor portion may be formed from any material having the appropriate strength and rigidity for supporting a chromatography column, including any appropriate metal, plastic (e.g., polyvinyl chloride (PVC), polypropylene, acrylonitrile butadiene styrene (ABS), polylactic acid (PL A), polyethylene terephthalate (PET), polycarbonate (PC), polyether ether ketone (PEEK), or others), rubber, natural or synthetic polymer, composite materials, or any other appropriate material or combination of materials.

[0031] However, as discussed above, it will be appreciated that some materials having the appropriate strength and rigidity for supporting a chromatography column may additionally have a hardness that may create a risk of damaging the glass column. Accordingly, in some embodiments, the floor portion may additionally provide a cushioned support for a chromatography column. For example, in some embodiments, the floor portion may include a structural material, such as a metal or a plastic, as well as a cushioning material, such as a rubber or a polymer. In such embodiments, the cushioning material may reduce a risk of damage to the chromatography column that may result from contact between the chromatography column and the floor portion. In some such embodiments, a floor portion may comprise a rubber-coated metal or similar material or combination of materials.

[0032] A wall portion may be disposed around a periphery of the floor portion. The wall portion may extend from a first side of the floor portion, such that the wall portion may be configured to maintain an upright position of the chromatography column when the chromatography column is disposed within the internal volume. For example, the wall portion may extend from the floor portion to a distance or height sufficient to prevent a chromatography column from tipping over when the chromatography column is rested on the floor portion. In some embodiments, the wall portion may be formed as an annular cylinder having an internal surface and an external surface. The wall portion may be formed from any appropriately rigid material, including any appropriate plastic (e.g., polyvinyl chloride (PVC), polypropylene, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), polyethylene terephthalate (PET), polycarbonate (PC), polyether ether ketone (PEEK), or others), metal (e.g., aluminum, steel, nickel alloys, zinc alloys, or any other appropriate metal or alloy), composite material, or any combination thereof. Additionally, the wall portion may be formed by any appropriate manufacturing process, including additive manufacturing processes, subtractive manufacturing processes, molding processes (e.g., injection molding, extrusion molding), casting processes, or any combination thereof.

[0033] An internal volume may be defined by an internal surface of a wall portion and a first side of a floor portion. The internal volume may be sized, shaped, and/or configured to receive at least a portion of a chromatography column. In some embodiments, the internal volume may be substantially cylindrical, having a diameter defined by a diameter of the internal surface of the wall portion. In other embodiments, the internal volume may be formed in any appropriate geometry, including geometries having a cross-section with any appropriate number of sides. For example, in various embodiments, an internal volume may have a triangular cross-section, a square or rectangular cross-section, a pentagonal, hexagonal, or octagonal cross-section, or any other regular or irregular cross-section that may be suitable for maintaining an upright position of a chromatography column disposed in the internal volume. It will be appreciated that, for internal volumes having non-circular crosssections, the wall portion may be shaped appropriately to form the non-circular cross-section of the internal volume. In some embodiments, the height of the internal volume or wall portion may be measured from a floor plane of a floor portion to a point of a wall portion that is furthest from the floor plane or floor portion.

[0034] In some embodiments, a height of the internal volume or wall portion may be selected based on a length, a height, a weight, a diameter, a center of gravity, or other parameters of a chromatography column that is intended to be supported by the chromatography column stand. In some embodiments, a height of an internal volume or wall portion may be about a quarter, a third, a half, or two thirds of a length or height of a chromatography column. In some embodiments, a height of an internal volume or wall portion may be selected to maintain the upright position of, or to prevent the tipping or tilting of, a chromatography column having a height of 50 centimeters (cm), 75 cm, 95 cm, or any other appropriate height.

[0035] Accordingly, in some embodiments, the height of the internal volume or wall portion may be greater than or equal to 10 cm, 12.5 cm, 15 cm, 17.5 cm, 20 cm, 30 cm, or any other appropriate height. Additionally, the height of the internal volume or wall portion may be less than or equal to 45 cm, 35 cm, 30 cm, 25 cm, 22.5 cm, 20 cm, or any other appropriate height. Combinations of the foregoing are contemplated, including, for example, greater than or equal to 10 cm and less than or equal to 45 cm, greater than or equal to 17.5 cm and less than or equal to 22.5 cm, or any other appropriate combination of the foregoing. Of course, while particular ranges for the height are provided, it will be appreciated that other ranges both greater than and less than those noted above are also contemplated as the disclosure is not limited in this fashion. [0036] Additionally, in some embodiments, a diameter of the internal volume or wall portion may be selected based on a length, a height, a weight, a diameter, a center of gravity, or other parameters of a chromatography column that is intended to be supported by the chromatography column stand. In some embodiments, a diameter of an internal volume or wall portion may be about the same as or only slightly greater than an outer diameter of a chromatography column that is intended to be supported, such that the chromatography column may be prevented from translating horizontally (i.e., in-plane with a floor or surface on which the stand may be disposed), tipping, or tilting within the internal volume or wall portion. In some embodiments, a diameter of an internal volume or wall portion may be selected to maintain the upright position of, or to prevent the translation, tipping, or tilting of, a chromatography column having an inner diameter of 10 cm and/or an outer diameter of 12 cm, an inner diameter of 14 cm and/or an outer diameter of 16 cm, an inner diameter of 20 cm and/or an outer diameter of 22 cm, an inner diameter of 30 cm and/or an outer diameter of 32 cm, or any other appropriate diameter or combination of diameters. In some embodiments, the diameter of the internal volume or wall portion may be between around 2 cm and around 5 cm greater than an outer diameter of the chromatography column to be supported, although it will be appreciated that this relationship may not be required in all embodiments.

[0037] Accordingly, in some embodiments, the diameter of the internal volume or wall portion may be greater than or equal to 14 cm, 18 cm, 24 cm, 34 cm, or any other appropriate diameter. Additionally, the diameter of the internal volume or wall portion may be less than or equal to 17 cm, 21 cm, 27 cm, 37 cm, or any other appropriate diameter. Combinations of the foregoing are contemplated, including, for example, greater than or equal to 14 cm and less than or equal to 37 cm, greater than or equal to 14 cm and less than or equal to 17 cm, greater than or equal to 18 cm and less than or equal to 21 cm, greater than or equal to 24 cm and less than or equal to 27 cm, or any other appropriate combination of the foregoing. Of course, while particular ranges for the diameter of the internal volume are provided, it will be appreciated that other ranges both greater than and less than those noted above are also contemplated as the disclosure is not limited in this fashion.

[0038] A base portion of a chromatography column stand may be configured to provide stability to the stand and to a chromatography column disposed within the stand. For example, the base portion may be configured to maintain an upright position of the chromatography column when the chromatography column is disposed within the internal volume. In some embodiments, the base portion may extend from an external surface of the chromatography column stand. Additionally, in some embodiments, the base portion may include at least one brace disposed at a periphery of the stand, a periphery of the floor portion, and/or a periphery of the wall portion. Each of the plurality of braces may extend out from or be disposed on an external surface of the wall portion and/or the base portion and may extend radially out from a center axis of the chromatography column stand. In various embodiments, the one or more braces may comprise one brace, three braces, four braces, five braces, six braces, or any appropriate number of braces. In some embodiments with multiple braces, the braces may be spaced at equal intervals around the periphery of the stand. In some embodiments having a single brace, the single brace may comprise an annulus, a disc, or an annular disc having a diameter greater than a diameter of a wall portion, the disc extending radially out from the external surface of the wall portion. The base portion, or components thereof, may be formed from any appropriately rigid material, including any appropriate plastic (e.g., polyvinyl chloride (PVC), polypropylene, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), polyethylene terephthalate (PET), polycarbonate (PC), polyether ether ketone (PEEK), or others), metal (e.g., aluminum, steel, nickel alloys, zinc alloys, or any other appropriate metal or alloy), composite material, or any combination thereof. Additionally, the base portion portion may be formed by any appropriate manufacturing process, including additive manufacturing processes, subtractive manufacturing processes, molding processes (e.g., injection molding, extrusion molding), casting processes, or any combination thereof.

[0039] In various embodiments, the base portion, the wall portion, and the floor portion may be formed as any number of separate components and assembled into a chromatography column stand, or the stand may be manufactured as a single piece. For example, in some embodiments, the chromatography column stand may be formed as a single piece by an additive manufacturing process. In other embodiments, the floor portion and the wall portion may be formed separately. For example, in some embodiments, the floor portion may comprise a plurality of floor elements comprising rubber-coated rods and the wall portion may include through-holes sized and shaped to receive the plurality rubber-coated rods. In some such embodiments, the rubber-coated rods may be inserted into the through- holes of the wall portion. Additionally or alternatively, in some embodiments, one or more braces of the base portion may be secured to an external surface of the wall portion and/or the base portion. For example, in some embodiments, each of the one or more braces may comprise an L-bracket or an angle bracket. Further, in some embodiments, the one or more braces may be secured to an external surface of the wall portion using one or more bands or fasteners, as will be described below. In other embodiments, one or more braces may be integrally formed as a single piece with the wall portion and/or the floor portion.

[0040] Turning to the figures, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and/or in any desired combination as the disclosure is not limited to only the specific embodiments described herein.

[0041] Fig. 1 depicts one embodiment of a chromatography column stand 100 supporting a chromatography column 200 in an upright position as shown. The stand 100 may comprise a base portion 102, a wall portion 104, and a floor portion 106. An internal volume of the chromatography column stand 100 may be defined by the floor portion 106 and the wall portion 104. In the embodiment depicted, the stand 100 may have a tubular or hollow cylindrical shape to accommodate a tubular or hollow cylindrical chromatography column 200 within a cylindrical internal volume of the stand 100. In some embodiments and as shown, the stand 100 and the internal volume thereof may be coaxial along a central axis A-A of the stand 100. Additionally, the internal volume may be sized and shaped such that a chromatography column 200 may be placed in an upright position in the internal volume to be coaxial with the stand and/or the internal volume along the central axis A-A. In some embodiments, the wall portion 104 may form an annular cylinder having a first end 126 and a second end 128. At the first end 126, the floor portion may extend across the internal volume formed within the wall portion in order to prevent the column 200 from passing through the first end 126 and to support at least a portion of a weight of the chromatography column 200. At the second end 128, the wall portion 104 may be open to receive the chromatography column 200 within the internal volume. As will be described in more detail with reference to Fig. 3, the wall portion 104 may extend to a height above the floor portion 106 that is selected to maintain an upright position of the chromatography column 200 when the column is disposed within the internal volume. For example, the wall portion 104 may extend to a height that is selected to prevent the chromatography column 200 from tipping or tilting within the internal volume. Additionally, as described above, a diameter of the wall portion 104 may be selected such that the wall portion may be configured to prevent the column 200 from translating horizontally (i.e., in-plane with a floor or surface on which the stand may be disposed), tipping, or tilting within the internal volume.

[0042] A base portion 102 of the stand 100 may be configured to stabilize the stand and/or a chromatography column 200 disposed within an internal volume of the stand 100. The base portion may be configured to prevent the chromatography column and/or the chromatography column stand disposed therein from tipping or tilting, thereby reducing a risk of damage to the chromatography column. For example, in the depicted embodiment, the base portion may include three braces (in the perspective view of Fig. 1, the stand may obstruct a view of one of the three braces, leaving only braces 102A, 102B visible). In some embodiments, a brace may comprise an L-bracket or other angle bracket. Each of the braces 102A, 102B may comprise a first leg 114A and a second leg 114B. The first and second leg 114A, 114B may be joined at about a right angle, although other angles may be selected as appropriate in other embodiments. The first leg 114A may be disposed along an external surface of the wall portion, and the second leg 114B may extend radially out from the central axis A-A at about a 90° angle from the first leg.

[0043] In some embodiments, the first leg 114A of each brace 102 may be secured to the wall portion 104. For example, in the embodiment of Fig. 1, the first leg 114A of each brace 102A, 102B may be secured to the wall portion 104 using one or more bands 108. A band 108 may extend around the first leg 114A of each brace 102 and around the wall portion 104 to secure each brace 102A, 102B to the wall portion 104. A band 108 may provide a compressive force acting inwardly towards the central axis A-A and/or towards a wall portion 104 in order to secure the braces against the wall portion 104. In embodiments which include bands, any appropriate number of bands may be included. For example, in the embodiment shown, two bands 108 are included to secure the three braces against the wall portion. However, it will be appreciated that other embodiments may include only one band, three bands, or any appropriate numbers of bands as the disclosure is not limited in this regard. In various embodiments, a band 108 may comprise an elastic band of an appropriate strength, or a band may comprise metallic components including springs, hose clamps, worm gear clamps, or any other appropriate mechanism.

[0044] In other embodiments, a brace may be secured to a wall portion 104 without the use of a band 108. For example, in the embodiment of Fig. 2, the braces 102A, 102B may be secured to the wall portion 104 using one or more fasteners 116. In various embodiments, the fasteners 116 may be any appropriate permanent or non-permanent fasteners, including threaded fasteners (e.g., bolts, screws, or threaded studs) or unthreaded fasteners (e.g., pins, nails, rods, rivets). In addition to bands and fasteners, it will be appreciated that a brace may be secured to a wall portion in any other appropriate manner, as the disclosure in not limited in this regard. For example, in various embodiments, a brace may be secured to a wall portion using any appropriate joining technique or mechanism, including welds, adhesives, epoxies, snap fittings, press fittings, lap fittings, or any other appropriate technique or mechanism.

[0045] In still other embodiments, a base portion may be integrally formed as a single piece with the wall portion and/or the floor portion, rather than as separate components which are assembled together. Additionally, while embodiments have been discussed and depicted with the base portion having a number of discrete legs to stabilize the stand and/or column, other embodiments may include a base portion having only a single brace. For example, the cross-sectional view of Fig. 3 A depicts an embodiment in which the base portion comprises a single brace 102 extending radially at a 90° angle from an external surface 122 of the wall portion 104. In this embodiment, the brace 102 and the wall portion 104 may be formed as a single component. Further, the brace 102 may comprise an annular disc extending radially out from the external surface 122, or away from a central axis A- A of the stand 100.

Although Fig. 3 A is described as including a brace shaped as an annular disc, it will be appreciated that a single brace may be implemented using any appropriate geometry, including a rectilinear brace or a brace having any appropriate regular, irregular, symmetric, or asymmetric geometry.

[0046] Without wishing to be bound by theory, it will be appreciated that the stability provided by the base portion may depend at least partially on a length of the base portion. In particular, the stability provided by a base portion may depend at least partially on a length of the base portion as measured radially out from the central axis A-A or from the external surface 122 of the wall portion. For example, as shown in Fig. 3 A, the length /., measured from the external surface 122, may be selected to provide stability to the stand 100 and/or the column 200 when the column 200 is disposed in the stand. Accordingly, it will be appreciated that the length L may be selected based at least in part on certain dimensions or parameters of the chromatography column stand and/or of the chromatography column which is intended to be supported. In some embodiments, the length L may be selected based at least in part on a height He or a diameter of the chromatography column 200 (for example, an outer diameter De of the chromatography column 200), or on a wall diameter Dw of the chromatography column stand. For example, the length L may be between about 0.5 times the wall diameter Dw and about 1.5 times the wall diameter Dw (i . e. , 0.5Dw< L < 1.5Dw), although it will be appreciated that longer and shorter lengths are also contemplated. Additionally or alternatively, the length L may be selected based at least in part on a weight of the column 200, or on any other appropriate parameter of the chromatography column or the stand, such as a weight distribution along a length or height of the column.

[0047] In view of the above, in various embodiments, a length L of a brace or a base portion may be greater than or equal to 5 cm, 7 cm, 9 cm, 12 cm, 14 cm, 18 cm, 21 cm, 24 cm, 27 cm, 36 cm, or any other appropriate length. Additionally, the length of the brace or base portion may be less than or equal to 50 cm, 40.5 cm, 31.5 cm, 27 cm, 25.5 cm, 21 cm, 17 cm, 13.5 cm, 10.5 cm, 8.5 cm, or any other appropriate length. Combinations of the foregoing are contemplated, including, for example, greater than or equal to 5 cm and less than or equal to 50 cm; greater than or equal to 7 cm and less than or equal to 25.5 cm; greater than or equal to 9 cm and less than or equal to 31.5 cm; greater than or equal to 12 cm and less than or equal to 40.5 cm; or any other appropriate combination of the foregoing. Of course, while particular ranges for the length are provided, it will be appreciated that other ranges both greater than and less than those noted above are also contemplated as the disclosure is not limited in this fashion.

[0048] Additionally, without wishing to be bound by theory, it will be appreciated that the stability provided by the wall portion 104 may depend at least partially on a height of the wall portion. Accordingly, a height of a wall portion of a chromatography column stand may be selected based at least in part on certain dimensions or parameters of the chromatography column which is intended to be supported. For example, as shown in Fig.

3 A, the wall height Hw may be selected based at least in part on a height He or a diameter of the chromatography column 200 (for example, the outer diameter De of the chromatography column 200). Additionally or alternatively, the wall height Hw may be selected based at least in part on a weight of the column 200, or on any other appropriate parameter of the chromatography column or the stand, such as a weight distribution along a length of the column. [0049] Similarly, without wishing to be bound by theory, it will be appreciated that the stability provided by the wall portion 104 may depend at least partially on a diameter of the wall portion. It will be noted that the diameter of the wall portion 104 may determine the diameter of the internal volume 118, as well as the degree to which a chromatography column 200 disposed within the internal volume 118 may translate, tilt, or tip. Accordingly, a diameter of a wall portion of a chromatography column stand may be selected based at least in part on certain dimensions or parameters of the chromatography column which is intended to be supported. For example, as best depicted in Fig. 3B, the wall diameter Dw may be selected based at least in part on an outer diameter De of the chromatography column 200. Additionally or alternatively, the wall diameter Dw may be selected based at least in part on a weight of the column 200, or on any other appropriate parameter of the chromatography column or the stand, such as a weight distribution along a length of the column.

[0050] Also shown in Fig. 3B, in some embodiments a chromatography column stand may be configured to accommodate chromatography columns of multiple different diameters. For example, a stand may be configured to receive and support either a first chromatography column having a first outer diameter or a second chromatography column having a second outer diameter, the second outer diameter being smaller than the first outer diameter. In some such embodiments, and as shown in Fig. 3B, the chromatography column stand may include a removable sleeve 110. In some embodiments, the removable sleeve 110 may be formed as an annular cylinder having an inner diameter and an outer diameter. In various embodiments, a removable sleeve may be formed from any appropriately rigid material, including any appropriate plastic (e.g., polyvinyl chloride (PVC), polypropylene, acrylonitrile butadiene styrene (ABS), polylactic acid (PL A), polyethylene terephthalate (PET), polycarbonate (PC), poly ether ether ketone (PEEK), or others), metal (e.g., aluminum, steel, nickel alloys, zinc alloys, or any other appropriate metal or alloy), composite material, or any combination thereof. Additionally, the removable sleeve may be formed by any appropriate manufacturing process, including additive manufacturing processes, subtractive manufacturing processes, molding processes (e.g., injection molding, extrusion molding), casting processes, or any combination thereof.

[0051] As shown in Fig. 3B, the outer diameter of the removable sleeve 110 may correspond to an inner diameter Dw of the wall portion 104, such that the removable sleeve 110 may fit securely within the internal volume 118 without translating horizontally therein. Additionally, the removable sleeve may have an inner diameter which may correspond to an outer diameter De of a second chromatography column 202, which may have a smaller outer diameter than the chromatography column 200 of Fig. 3 A. In some embodiments and as shown, a height Hs of the removable sleeve may correspond to a height of the wall portion Hw, such that the removable sleeve 110 and the wall portion 104 may terminate at about the same distance or height from the floor portion 106. However, it will be appreciated that in other embodiments, the height of the removable sleeve Hs may be greater than or less than the height of the wall portion Hw, as the disclosure is not limited in this regard.

[0052] The top view of Fig. 4 A depicts a floor portion 106 of one embodiment of a chromatography column stand 100 according to the present disclosure. In the embodiment of Fig. 4A, the chromatography column stand 100 comprises three braces 102A, 102B, 102C, each brace having a first leg 114A and a second leg 114B, as described above. In the embodiment of Fig. 4A, the floor portion 106 may comprise a plurality of floor elements 112. In some embodiments, the floor portion and/or the plurality of floor elements 112 may be configured to support at least a portion of a weight of a chromatography column without damaging the chromatography column. Each of the floor elements 112 may extend across the first end of the internal volume 118 (see Fig. 1 for a depiction of the first end 126).

[0053] As described above, the floor elements 112 may be any appropriate material or combination of materials. For example, in some embodiments, each of the floor elements 112 may comprise one or more rods formed from a metal, plastic, composite, or other structural material, and one or more rod may optionally have a layer or coating of rubber, polymer, or other cushioning material disposed on an external surface of the rod. It will be appreciated that a rod may have any appropriate cross-section. For example, in various embodiments, a rod may have a circular cross-section, an annular cross-section (i.e., a pipe), an elliptical cross-section, a square or rectangular cross-section, a polygonal cross-section, a T- or X- shaped cross-section, or any other regular or irregular cross-section. It will further be appreciated that, in some embodiments, the rods or floor elements may have varying lengths, as the distance required to span the first end of the wall portion may vary according to the positioning of a given rod or floor element. For example, in Fig. 4A, a length of a floor element 112 disposed along a center line C-C of the first end may be greater than a length of a floor element spaced apart from the center line C-C. [0054] In some embodiments, each rod or floor element may have a cross-sectional width or a diameter selected to support a weight of a chromatography column. For example, in some embodiments, a cross-sectional width or a diameter of a rod or floor element may be greater than or equal to 0.125 inches, 0.25 inches, 0.375 inches, 0.5 inches, 0.625 inches, 0.75 inches, or any other appropriate width or diameter. Additionally, the cross-sectional width or the diameter of the rod or floor element may be less than or equal to 0.5 inches, 0.625 inches, 0.75 inches, 0.875 inches, 1.0 inch, 1.5 inches, 2.0 inches, or any other appropriate width or diameter. Combinations of the foregoing are contemplated, including, for example, greater than or equal to 0.125 inches and less than or equal to 2.0 inches, greater than or equal to 0.375 inches and less than or equal to 0.625 inches, or any other appropriate combination of the foregoing. Of course, while particular ranges for the width or diameter of a rod or floor element are provided, it will be appreciated that other ranges both greater than and less than those noted above are also contemplated as the disclosure is not limited in this fashion.

[0055] In various embodiments, the floor elements 112 may be secured to or formed integrally with the wall portion 104 and/or the base portion. For example, in some embodiments, each floor element 112 may inserted into through-holes formed on opposing sides of the first end of the wall portion 104. Alternatively, in some embodiments, the wall portion 104 may be formed as a single piece including the floor elements 112, for example using an additive manufacturing process or a molding process (e.g., injection molding).

[0056] Although Fig. 4A depicts an embodiment having five floor elements, it will be appreciated that any number of floor elements may be included in a floor portion, as the disclosure is not limited in this regard. In other embodiments, a floor portion may include one, two, three, four, five, six, or any other suitable number of floor elements. Additionally, although Fig. 4A depicts an embodiment in which the floor elements are disposed parallel to one another, it will be appreciated that two or more floor elements may be disposed across the first end of the internal volume with any appropriate angle between them.

[0057] Fig. 4B depicts the embodiment of Fig. 4A with a removable sleeve 110 inserted into the internal volume 118. The annular removable sleeve 110 may have an outer diameter corresponding to the wall diameter Dw and an inner sleeve diameter Ds corresponding to a chromatography column having a diameter significantly smaller than the wall diameter Dw. Accordingly, the annular removable sleeve 110 may be configured to allow the chromatography column stand 100 to receive a chromatography column having a diameter which is significantly smaller than the wall diameter Dw. For example, in some embodiments, a wall diameter Dw of about 26 cm may be selected to accommodate a chromatography column having an inner diameter of 20 cm and/or an outer diameter of 22 cm. In such embodiments, a removable annular removable sleeve 110 having an inner sleeve diameter Ds of 19 cm may be inserted into the internal volume 118 in order to accommodate a chromatography column having an inner diameter of 14 cm and/or an outer diameter of 16 cm.

[0058] Also shown in Fig. 4B, in some embodiments, a brace 102 A, 102B, or 102C of a base portion may have a width W, measured in a direction transverse to a measurement of the length L described above. Without wishing to be bound by theory, it will be appreciated that the stability provided by the base portion may depend at least partially on the width W. For example, as shown in Fig. 4B, the width W may be selected to provide stability to the stand 100 and/or the column 200 when the column 200 is disposed in the stand. Accordingly, it will be appreciated that the width W may be selected based at least in part on certain dimensions or parameters of the chromatography column stand and/or of the chromatography column which is intended to be supported. For example, the width W may be selected based at least in part on a height He or an outer diameter De of the chromatography column 200 (see Fig. 3 A). Additionally or alternatively, the width W may be selected based at least in part on a weight of the column 200, or on any other appropriate parameter of the chromatography column or the stand, such as a weight distribution along a length or height of the column. Additionally or alternatively, the width W may further be selected based at least in part on a number of braces of the base portion. For example, in an embodiment having a base portion with four braces, it may be desirable to select a greater width W than an embodiment having a base portion with twelve braces in order for both embodiments to provide the same stability to the same chromatography column. Additionally, it will be appreciated that the width W may be uniform for all braces, or the width W may be non- uniform. In some embodiments, the width IF of a given brace may be selected based at least in part on a spacing of the braces. For example, in embodiments where braces are spaced equally, the width W may be uniform for all braces. Alternatively, in embodiments where braces are unequally spaced, it may be desirable to select a greater width W in areas where the braces are spaced further apart than in areas where the braces are spaced closer together. [0059] In view of the above, in some embodiments, a width IK of a brace or a base portion may be greater than or equal to 0.5 cm, 1 cm, 1.5 cm, 2 cm, 5 cm, or any other appropriate width. Additionally, the width of the brace or base portion may be less than or equal to 15 cm, 10 cm, 7.5 cm, 5 cm, 2.5 cm, or any other appropriate width. Combinations of the foregoing are contemplated, including, for example, greater than or equal to 0.5 cm and less than or equal to 15 cm, greater than or equal to 1.5 cm and less than or equal to 2.5 cm, or any other appropriate combination of the foregoing. Of course, while particular ranges for the width are provided, it will be appreciated that other ranges both greater than and less than those noted above are also contemplated as the disclosure is not limited in this fashion.

[0060] Fig. 5 depicts an embodiment similar to the embodiment of Fig. 4A, with three differences to illustrate a few of the variations contemplated by the present disclosure. First, the floor portion may comprise eleven floor elements 112, and each floor element may be relatively narrow and more closely spaced when compared to the embodiment of Fig. 4A. Second, the base portion may comprise four braces 102A-D. Third, each of the braces 102A- D may have a greater width W than the width shown in the embodiment of Fig. 4 A.

[0061] Fig. 6 depicts an embodiment in which the base portion may comprise only a single brace 102, the brace 102 comprising an annular disc extending from the wall portion 104. Additionally, in the embodiment of Fig. 6, the floor portion 106 may comprise a single floor element 112. In some embodiments and as shown, the floor element 112 may comprise a grid structure. Although the embodiment of Fig. 6 may include a floor portion having a grid formed by a single floor element, it will be appreciated that in other embodiments, the floor portion may have a grid formed from multiple floor elements. Additionally, although the embodiment of Fig. 6 may include a single floor element which is formed as a grid structure, it will be appreciated that in other embodiments, a floor portion may include a single floor element formed in any appropriate geometry. For example, in some embodiments, a single floor element may comprise a rod as described above. In other embodiments, a single floor element may comprise a coil, or any other appropriate geometry.

[0062] In the embodiment of Fig. 7, the floor portion 106 may comprise a wire mesh extending across the first end of the internal volume. The wire mesh may include wires formed from a structural material as discussed above, including any appropriate metal, such as steel or stainless steel. The wires may be formed in any appropriate gauge, thickness, or spacing. Optionally, the wire mesh may further comprise a cushioning material disposed on the wires. For example, in some embodiments, a wire mesh may comprise a stainless steel mesh coated with a rubber, plastic, elastomer, or polymer coating. Additionally, the embodiment of Fig. 7 depicts a base portion having six braces 102A-F.

[0063] Fig. 8 illustrates a method performing maintenance on a chromatography apparatus using a chromatography column stand according to the present disclosure. At step 810, a chromatography column may be removed from the chromatography apparatus. This step may include removing a chromatography column having an inner diameter of about 10 cm, about 14 cm, about 20 cm, about 30 cm, or any other appropriate diameter. Additionally or alternatively, removing a chromatography column from a chromatography apparatus may include removing a chromatography column having a height of about 50 cm, 75 cm, 100 cm, or any other appropriate height. While chromatography columns having a height greater than 100 cm are commercially available, and while chromatography column stands for columns greater than 100 cm are within the scope of this disclosure, it will be understood by practitioners in the art that, when larger sized chromatography columns are required, columns of increased diameter may, in some instances, be preferred over columns of increased height due to the potential impracticalities of handling very tall, heavy chromatography columns.

[0064] At step 820, a removable sleeve may be optionally placed into a chromatography column stand. This step may comprise placing the removable sleeve into an internal volume of the chromatography column stand. Alternatively, the chromatography column may optionally be placed into a removable sleeve, and the chromatography column and the removable sleeve may be placed together into the chromatography column stand or an internal volume thereof.

[0065] At step 830, the chromatography column may be placed into the chromatography column stand. In embodiments in which the removable sleeve is placed into the chromatography column stand, the chromatography column may be placed into the removable sleeve. In some embodiments, the chromatography column may be placed in an upright position into the chromatography column stand, an internal volume of the stand, or a removable sleeve disposed in the stand or the internal volume.

[0066] At step 840, a maintenance operation may be performed on the chromatography apparatus while the chromatography column is removed from the apparatus. Maintenance operations may include: cleaning, disassembling, or otherwise accessing one or more portions or components of the chromatography apparatus, including the chromatography column; changing one or more filters of the chromatography apparatus, including one ore more mesh filters; adjusting one or more wheels of the chromatography apparatus, including one or more caster wheels, or adjusting one or more feet or supports of the chromatography apparatus; or any other appropriate maintenance operations which may be performed on a chromatography apparatus.

[0067] At step 850, the chromatography column may be removed from the chromatography column stand. In embodiments in which the removable sleeve is placed into the chromatography column stand, the chromatography column may be removed from the removable sleeve. At step 860, the chromatography column may be replaced within the chromatography apparatus.

[0068] While several embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those of skill in the art. Accordingly, the foregoing description and drawings are by way of example only. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teaching(s) of the present disclosure is/are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure. 1