Syringe, assembly, and method of manufacture

Abstract

A syringe, an assembly for use in the filling process, and an associated method of manufacture are disclosed. The syringe may include a reservoir that is filled or configured to be filled with a preselected volume of drug (e.g., 3 mL of drug or a preselected volume that is about 3 mL of drug). The syringe may further include a wall that includes a cylindrical portion. The cylindrical portion of the wall may include (a) an inner diameter that is equal to or approximately equal to the standard inner diameter of a 5 mL syringe, or the standard outer diameter of a preselected volume or any other syringe volume that is not equal to 3 mL; and / or (b) an outer diameter that is equal to or approximately equal to the standard outer diameter of a 5 mL syringe, or the standard outer diameter of a preselected volume or any other syringe volume that is not equal to 3 mL.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 214,218, filed June 23, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to devices for injecting drugs into a patient, and to the manufacture of such devices. [Background technology]

[0003] Syringes are commonly used in the medical field to administer drugs to patients by injection, and also have other uses and purposes.Syringes are often produced in large quantities, and multiple suppliers are involved, each specializing in the manufacture or assembly of different parts or components of the syringe.For example, one supplier may manufacture the barrel and / or stopper of the syringe, and another supplier may manufacture the drug and / or, in the case of pre-filled syringes, fill the barrel with the drug, for example under aseptic conditions.

[0004] The industry has adopted standard syringe dimensions to facilitate coordination among various suppliers, among other reasons. This standardization has made syringe production more efficient, resulting in lower costs for patients. For example, certain standard syringe dimensions are specified in the International Organization for Standardization (ISO) 11040-4. As a result of this standardization, various syringe components are only readily available in certain dimensions. This in turn can impose constraints on manufacturers and designs of devices that are intended to incorporate syringes, for example. Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure illustrates syringes, assemblies, and associated manufacturing methods that embody advantageous alternatives to existing syringes, assemblies, and manufacturing methods, and that may address one or more of the problems or needs noted herein, as well as provide other benefits and advantages. [Means for solving the problem]

[0006] One aspect of the present disclosure provides a syringe including at least a reservoir and a wall. The wall may include at least a cylindrical portion. The reservoir may be filled or configured to be filled with a preselected volume of drug (e.g., a preselected volume of drug, such as 3 mL of drug or about 3 mL of drug). The cylindrical portion may include: (a) an inner diameter equal to or approximately equal to a standard inner diameter of a 5 mL syringe, or a standard outer diameter of a preselected volume or any other syringe volume not equal to 3 mL; and / or (b) an outer diameter equal to or approximately equal to a standard outer diameter of a 5 mL syringe, or a standard outer diameter of a preselected volume or any other syringe volume not equal to 3 mL. In some embodiments, ISO 11040-4 may represent the standard inner diameter of a 5 mL syringe, and / or the standard outer diameter of a 5 mL syringe.

[0007] The syringe may have a first length measured between a proximal inner surface of the wall and a proximal outer surface of the wall. The first length of the syringe may be less than the standard length of a 3 mL syringe or 72.2 mm, and / or the first length of the syringe may be equal to or approximately equal to the standard length of a 1 mL syringe or 54 mm. In some embodiments, ISO 11040-4 may refer to the standard length of a 3 mL syringe and / or the standard length of a 1 mL syringe.

[0008] Another aspect of the disclosure provides a method of manufacturing a syringe having a preselected volume (e.g., a preselected volume that is 3 mL). The method may include preparing or obtaining a specification for standard syringe dimensions, the specification indicating, for each of a plurality of syringe volumes, at least (a) one of a plurality of standard diameters and (b) one of a plurality of standard lengths. The specification for standard syringe dimensions may be included, for example, in ISO 11040-4. The method may further include selecting a standard diameter from among a plurality of standard diameters included in the specification, where the syringe volume indicated by the specification for the selected standard diameter is not equal to the preselected volume. In some embodiments, the syringe volume indicated by the specification for the selected standard diameter may be 5 mL.

[0009] A further aspect of the present disclosure provides an assembly for use in at least a filling process. The assembly may include a tub and a plurality of syringes each at least partially disposed in the tub. One or more of the syringes may include a preselected volume of 3 mL of drug, or a reservoir filled or configured to be filled with about 3 mL of drug. Additionally, one or more of the syringes may have a length that is shorter than the standard length for a 3 mL syringe. In some embodiments, the tub may have a height equal to or approximately equal to 3 inches or 76.2 mm.

[0010] The present disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. The omission of such elements in some of the drawings does not necessarily indicate the presence or absence of the particular elements in any of the illustrative embodiments, unless explicitly depicted in the corresponding written description. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0011] [Figure 1] This is a chart of standard dimensions for syringes as specified in ISO 11040-4. [Diagram 2] 1 is a perspective view of an exemplary syringe according to various embodiments. [Diagram 3] FIG. 3 is a side view of the syringe of FIG. 2. [Figure 4] FIG. 4 is a cross-sectional view along the longitudinal axis A of the syringe of FIG. [Diagram 5] FIG. 5 is a top view of the flange of the syringe of FIG. 4, with the stopper omitted. [Figure 6] FIG. 6 is a perspective view of a stopper of the syringe of FIGS. [Figure 7] FIG. 7 is a side view of the stopper of FIG. 6. [Figure 8] 8 is a cross-sectional view taken along the major axis A of the stopper of FIG. 7. FIG. [Figure 9] FIG. 1 is an exploded perspective view of an exemplary assembly for use in at least a filling process. [Figure 10] FIG. 10 is an unexploded perspective view of the assembly of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The present disclosure generally relates to the design and manufacture of syringes. The syringes disclosed herein may deviate in at least some respects from the standard dimensions (e.g., those specified in ISO 11040-4) used to manufacture syringes, for example, to achieve a desired syringe design, to fit existing manufacturing processes, and / or to satisfy externally imposed design constraints, such as volume and / or length requirements necessary to incorporate the syringe into an automated drug delivery device, such as an auto-injector and / or an internal injector, and / or ergonomic considerations. The manner in which the presently disclosed syringes deviate from the standard dimensions is strategically selected to minimize or eliminate any potential customization or modification to standard manufacturing equipment or practices employed in the manufacture of the presently disclosed syringes. This streamlines the manufacturing process of the presently disclosed syringes and potentially expands the pool of suppliers from which the parts necessary to manufacture the presently disclosed syringes can be sourced. For example, to achieve a syringe having a desired volume and / or desired length, the present disclosure describes selecting standard dimensions where standard syringe dimensional specifications, such as ISO 11040-4, are not related to the desired volume and / or desired length. This may enable, for example, the manufacture of a syringe of the desired volume and / or desired length utilizing standard tubing canes, which may be readily available from a variety of suppliers in standard diameters. These and other advantages and benefits will be apparent to those of skill in the art upon review of the present disclosure.

[0013] FIG. 1 shows a chart of standard dimensions for syringes as defined in ISO 11040-4. The entire contents of ISO 11040-4 are incorporated herein by reference. The chart in FIG. 1 defines various standard dimensions (measured in millimeters (mm)) for each of a number of nominal volumes (measured in milliliters (mL)) of a syringe. In this chart, D1 corresponds to the outer diameter of the barrel of the syringe (e.g., a glass barrel), D2 corresponds to the inner diameter of the barrel of the syringe, and L1 corresponds to the length of the barrel of the syringe. This chart indicates, for example, that a syringe with a nominal volume of 5 mL (sometimes referred to as a "5 mL syringe") should be manufactured with a barrel (e.g., a glass barrel) with a standard outer diameter D1 of 14.45 mm±0.1 mm, a standard inner diameter D2 of 11.85 mm±0.2 mm, and a length L1 of 66.7 mm±0.75 mm. As another example, the chart indicates that a syringe having a nominal capacity of 3 mL (sometimes referred to as a "3 mL syringe") should or must be manufactured with a barrel (e.g., a glass barrel) having a standard outer diameter D1 of 10.85 mm ± 0.1 mm, a standard inner diameter D2 of 8.65 mm ± 0.2 mm, and a length L1 of 72.2 ± 0.5 mm. As a further example, the chart indicates that a "long version" of a syringe having a nominal capacity of 1 mL (commonly referred to as a "1 mL syringe") should be manufactured with a barrel (e.g., a glass barrel) having a standard outer diameter D1 of 8.15 mm ± 0.1 mm, a standard inner diameter D2 of 6.35 mm ± 0.1 mm, and a length L1 of 54 mm ± 0.5 mm.

[0014] The inventors of the present disclosure have found that standard barrel lengths, for example as specified in ISO 11040-4, may not be desirable and / or acceptable for certain applications. For example, it may be medically necessary to inject a certain drug in a 3 mL dose, but a drug delivery device (e.g., an autoinjector or an internal injector) used with a syringe containing a 3 mL dose may not be configured to accommodate or otherwise accommodate a syringe having a barrel length L1 equal to or greater than 72.2±0.5 mm, the barrel length L1 specified in ISO 11040-4 for a 3 mL syringe. As a more specific example, a barrel length equal to or approximately equal to the barrel length L1 specified in ISO 11040-4 for a 1 mL syringe may be appropriate (e.g., from an engineering perspective) for a certain application requiring a 3 mL syringe. Rather than redesigning the drug delivery device to fit the barrel length L1 as specified in ISO 11040-4 for a 3 mL syringe, or designing a customized syringe that completely ignores the standard dimensions specified in ISO 11040-4, the inventors of the present application have selected various standard syringe dimensions to arrive at a novel combination of standard and / or non-standard syringe dimensions that advantageously meet the dimensional requirements of a particular application (e.g., an auto-injector, or an internal injector, or the use of the syringe in a manufacturing process), and further, any potential customization or modification to standard or existing manufacturing equipment or practices employed in the manufacture of the syringe is nevertheless minimized or eliminated. As an example, a 3 mL syringe according to one embodiment of the present disclosure may be manufactured with a standard outer diameter D1 and / or a standard inner diameter D2 as specified in ISO 11040-4 (or another specification for standard syringe dimensions) for a 5 mL syringe, and a barrel length L1 that is shorter than the standard barrel length L1 as specified in ISO 11040-4 (or another specification for standard syringe dimensions) for a 3 mL syringe (e.g., a barrel length L1 that is equal to or approximately equal to the standard barrel length L1 as specified in ISO 11040-4 (or another specification for standard syringe dimensions) for a 1 mL syringe).

[0015] 2-5 illustrate one embodiment of a syringe 10 constructed in accordance with the principles of the present disclosure. In general, the syringe 10 may be configured to deliver (e.g., inject) a drug (which may also be referred to herein as a medicine or formulation) to, for example, a patient. The drug may be, but is not limited to, various biological agents such as peptides, peptibodies, and / or antibodies. The present disclosure is not limited to a particular form or state of the drug, but the drug may be in a fluid or liquid form, a gelatinous form, and / or a powder form.

[0016] The syringe 10 may include a longitudinal axis A and a proximal end 12 and a distal end 14 disposed at respective locations along the longitudinal axis A. The proximal end 12 of the syringe 10 may include, for example, a barrel 16 (e.g., a body portion) and / or a flange 18. The distal end 14 of the syringe 10 may include, for example, a neck 20, a needle 22, and / or a removable sterility barrier 24. The syringe 10 may include a wall 26 that defines any one or any combination of the barrel 16, the flange 18, and the neck 20. By way of example, the wall 26 may include a cylindrical portion 28 that defines at least a portion or all of the barrel 16. The syringe 10 may further include a stopper 32 (also referred to as a "plunger" or "plunger stopper" depending on the context) disposed partially or entirely within the barrel 16.

[0017] 4, the interior space of barrel 16 may include at least a first portion P1, a second portion P2, a third portion P3, and / or a fourth portion P4, each of which may correspond to a three-dimensional space having a preselected length measured along the longitudinal axis A and / or a three-dimensional space necessary to perform a desired function. As an example, the first portion P1 may correspond to a portion of the internal space of the barrel 16 that is proximal to the stopper 32; the second portion P2 may correspond to a portion of the internal space of the barrel 16 that is occupied by the stopper 32 prior to use of the syringe 10; the third portion P3 may correspond to a portion of the internal space of the barrel 16 that is distal to the stopper 32 and provides a gap (e.g., an air gap) between the stopper 32 and the medicament when the syringe 10 is placed in an upright orientation prior to use; and / or the fourth portion P4 may correspond to a portion of the internal space of the barrel 16 that is partially or completely filled with the medicament when the syringe 10 is placed in an upright orientation prior to use.

[0018] The syringe 10 may further include a reservoir 30 that is partially or completely filled or configured to be filled with a preselected volume (e.g., a predetermined volume, an intended volume, and / or a maximum intended volume) of a drug. As an example, the reservoir 30 may correspond to at least a portion of the interior space of the barrel 16 and / or at least a portion of the interior space of the neck 20. As a more specific example, the reservoir 30 may correspond to a fourth portion P4 of the interior space of the barrel 16. As an even more specific example, the preselected volume of the reservoir 30 and / or the preselected volume of the drug in the reservoir 30 may correspond to the volume of at least the fourth portion P4 of the interior space of the barrel 16. As another example, the preselected volume of the reservoir 30 and / or the preselected volume of the drug in the reservoir 30 may correspond to the sum of the volume of the fourth portion P4 of the interior space of the barrel 16 and the volume of the interior space of the neck 20.

[0019] The reservoir 30 of the syringe 10 may be defined in part or in whole by a distal surface of the stopper 32 , an inner surface of the barrel 16 (eg, an inner surface of the cylindrical portion 28 of the wall 26 ), and / or the neck 20 .

[0020] The reservoir 30 may be partially or completely filled with a drug. In some embodiments, the reservoir 30 may be pre-filled with a drug, for example by the manufacturer, while in other embodiments, the reservoir 30 may be provided empty, requiring a downstream manufacturer or user to fill the reservoir 30 with a drug. The preselected volume of the reservoir 30 and / or the preselected volume of the drug within the reservoir 30 may be equal to or approximately (e.g., ±10% or ±5%) equal to any of the "nominal volumes" included in the chart of FIG. 1. As an example, the reservoir 30 and / or the drug therein may have a preselected volume equal to or approximately (e.g., ±10% or ±5%) equal to 3 mL.

[0021] The wall 26 of the syringe 10 may be partially or entirely made of a rigid or semi-rigid material including, for example, glass, plastic (eg, polypropylene), and / or any other suitable material or combination of materials.

[0022] The stopper 32 may be movably disposed within the barrel 16 such that the stopper 32 is movable at least distally along the longitudinal axis A from an initial position adjacent the proximal end of the barrel 16 to at least an end-of-administration or end-of-delivery position adjacent the distal end of the barrel 16. Distal movement of the stopper 32 may expel the drug from the syringe 10 through the needle 22. Proximal movement of the stopper 32 along the longitudinal axis A may also be possible, at least in some embodiments. The stopper 32 may be constructed of an elastomeric material, such as rubber, or any other suitable material. In some embodiments, the stopper 32 may be partially or entirely coated with a fluoropolymer film (e.g., FluroTec® barrier film). The stopper 32 may, for example, slidably and / or sealably contact an inner surface of the barrel 16 such that leakage of the drug in the reservoir 30 past the stopper 32 is prevented or inhibited when the stopper 32 is moved distally. As an example, the stopper 32 may form a liquid-tight and / or gas-tight seal with the inner surface of the cylinder 28 of the wall 26 .

[0023] The stopper 32 may include a generally cylindrical body portion 38 and one or more ribs 40a-d extending radially outward from the body portion 38, as shown in FIGS. 6-8. At least an outwardly facing surface of one or more of the ribs 40a-d may contact the inner surface of the barrel 16. Each of the ribs 40a-d may partially or entirely surround the body portion 38 of the stopper 32. The ribs 40a-d may be spaced apart from one another along a direction parallel to the longitudinal axis A. The cylindrical body portion 38 may include a cavity or opening to facilitate coupling of the stopper 32 to, for example, a plunger rod. As shown in FIG. 8, the cavity may be surrounded by a threaded inner surface 42 of the stopper 32. As an example, the threaded inner surface 42 may be configured to be threadably coupled to a threaded outer surface of a plunger rod.

[0024] The proximal end of the barrel 16 may include a proximal shank opening 34 that allows a plunger rod or other actuation element to extend into the barrel 16 and couple with the stopper 32 and / or move the stopper 32 relative to the wall 26. The neck 20 may include a distal shank opening 36 configured to provide a fluid connection with a drug in the reservoir 30. As an example, the needle 22 may be coupled to the distal end of the neck 20 and / or may be in fluid communication with the reservoir 30 via the distal shank opening 36. As a more specific example, the needle 22 may be secured (e.g., glued and / or staked) to the portion of the wall 26 that defines the neck 20 such that the needle 22 cannot move relative to the wall 26. The distal end of the needle 22 may include a sharp tip or other sharp feature that allows the distal end of the needle 22 to pierce and / or penetrate the skin, subcutaneous tissue, and / or other tissue of a patient. The needle 22 may be hollow and / or may include an axial passage parallel and / or coaxial with the longitudinal axis A of the syringe 10. At the distal end of the needle 22, one or more openings may be formed to allow the drug to flow out of the needle 22 to the patient during use of the syringe 10. The needle 22 may be made of metal and / or any other suitable rigid material. In alternative embodiments, the needle 22 may be omitted (such that the syringe 10 is considered, for example, a needleless syringe) or may not at least be directly connected to the wall 26 of the syringe 10. In certain such alternative embodiments, the neck 20 may be connected to and / or form a nozzle or other fluid line member (e.g., a luer lock fitting). In embodiments in which the needle 22 is omitted, the neck 20 may also be omitted and the opening in the distal axis of the barrel 16 may be covered with a septum or other structure that may provide selective fluid communication with the reservoir 30.

[0025] 4, the removable sterility barrier 24 may be coupled to the neck 20 and / or cover the distal end of the needle 22. The removable sterility barrier 24 may be configured to form an air-tight and / or liquid-tight seal with the neck 20 to provide a sterile or otherwise clean environment for storing the needle 22 prior to use of the syringe 10. Immediately or substantially immediately prior to use of the syringe 10, the removable sterility barrier 24 may be removed (e.g., by a user) from the neck 20 to expose the distal end of the needle 22. By way of example, the removable sterility barrier 24 may be a rigid needle shield (RNS) or a non-rigid needle shield (nRNS).

[0026] Dimensions of syringe 10 will now be described with reference to FIGS. 4-8. Cylindrical portion 28 of wall 26 of syringe 10 may have an outer diameter D1 and an inner diameter D2. By way of example, outer diameter D1 and / or inner diameter D2 of cylindrical portion 28 of wall 26 may be constant or substantially constant along longitudinal axis A. Part or all of barrel 16 may also have outer diameter D1 and / or inner diameter D2. In terms of what is being measured, outer diameter D1 and inner diameter D2 may correspond, respectively, to the outer diameter D1 and inner diameter D2 defined in ISO 11040-4 (discussed above in connection with FIG. 1). Flange 18 may have an outer diameter D3.

[0027] The syringe 10 may further include various lengths, some or all of which may be measured in a direction parallel or substantially parallel to the longitudinal axis A. As shown in FIG. 4, the syringe 10 may have a length L1 (sometimes referred to as a "barrel length") measured between a proximal outer surface of the wall 26 and a proximal portion of an inner surface of the wall 26. In some embodiments, the length L1 may correspond to the length of the cylindrical portion 28 of the wall 26 and / or the length of the barrel 16. With respect to what is measured by the length L1, the length L1 may correspond to the length L1 defined by ISO 11040-4 (discussed above in connection with FIG. 1). Additionally, the syringe 10 may have a length L2 measured between a proximal outer surface of the wall 26 and a distal outer surface of the wall 26. The latter may correspond to a distal outer surface of the neck 20 of the syringe 10 in some embodiments. Syringe 10 may further include a length L3 measured between the proximal outer surface of wall 26 and the distal surface of needle 22. In addition, syringe 10 may include a length L4 measured between the proximal outer surface of wall 26 and the distal outer surface of removable sterile barrier 24. Syringe 10 may also include a length L5 measured between the proximal outer surface of removable sterile barrier 24 and the distal outer surface of removable sterile barrier 24.

[0028] 7, the stopper 32 may include an outer diameter D4. By way of example, the outer diameter D4 may correspond to an outer diameter of one or more of the ribs 40a-d of the stopper 32. Additionally, the stopper 32 may have a length L6. As shown in FIG. 8, the length L6 may be measured between a distal outer surface of the stopper 32 and a proximal outer surface of the stopper 32.

[0029] One or more of the diameters D1-D4, one or more of the lengths L1-L6, and / or other dimensional values ​​of the syringe 10 may be selected to provide novel combinations of dimensions that achieve multiple objectives and / or balance competing needs. For example, the dimensions may be selected to provide a syringe having a design that: (a) is configured to store a preselected (e.g., predetermined, target, desired, etc.) volume of drug; (b) has ergonomic advantages; (c) can be manufactured using standard (or near-standard) manufacturing methods and / or equipment; (d) can be manufactured from standard tubing cane (e.g., standard glass tubing cane); (e) can be shipped in a standard syringe tub; (f) meets the structural and / or functional requirements of a drug delivery device, such as an autoinjector or an internal injector; and / or (g) minimizes deviations from standard syringe dimensions, such as those specified in ISO 11040-4.

[0030] As an example, in a scenario where the syringe 10 has a preselected volume (e.g., due to a required dose of a drug to be administered by the syringe 10), a method of manufacturing the syringe 10 according to embodiments of the present disclosure may include one or more of the following steps: First, a standard syringe dimension specification may be prepared or obtained for each of a plurality of syringe volumes, indicating any one or any combination of the following: a standard outer diameter D1, a standard inner diameter D2, and a standard length L1. The standard syringe dimension specification may be found, for example, in ISO 11040-4. Next, another standard dimension may be selected whose standard outer diameter D1, standard inner diameter D2, standard length L1, and / or specification does not associate with the preselected volume, but does associate with a syringe volume that is not, for example, equal to the preselected volume. For example, if the preselected volume is 3 mL, then a standard outer diameter D1 and / or standard inner diameter D2 whose specification associates with a 5 mL syringe may be selected. By doing so, one may have the flexibility to select a length L1 of the syringe 10 that is shorter or longer than a standard length L1 that specifications associate with a 3 mL syringe, for example, without compromising the ability to manufacture the syringe 10 from standard tubing cane (e.g., standard tubing cane traditionally used to manufacture 5 mL syringes). For example, one may select a length L1 that is equal to or approximately (e.g., ±10% or ±5%) equal to a standard length L1 that specifications associate with a 1 mL syringe. As another example, one may calculate the selected length L1 according to a mathematical formula, where the selected length L1 is:

number

[0031] As another example, syringe 10 may be designed to contain any one or any combination of the following: (a) reservoir 30 contains or is configured to contain 3 mL of drug or approximately (e.g., ±10% or ±5%) 3 mL of drug, such that, at least in some contexts, syringe 10 is considered to be a "3 mL syringe"; (b) wall 26 and / or cylindrical portion 28 of barrel 16 have an outer diameter D1 equal to or greater than 14.45 mm. (c) the wall 26 and / or the cylindrical portion 28 of the barrel 16 have an inner diameter D2 equal to or approximately equal to (e.g., ±10%, ±5%, or ±0.1 mm) 11.85 mm; (d) the flange 18 has an outer diameter D3 equal to or approximately equal to (e.g., ±10%, ±5%, or ±0.35 mm) 18 mm; (e) the wall 26 and / or the cylindrical portion 28 of the barrel 16 have a length L1 equal to or approximately equal to (e.g., ±10%, ±5%, or ±0.35 mm) 54 mm or 35.7 (f) the wall 26 has a length L2 equal to or approximately equal to (e.g., ±10%, ±5%, or ±0.5 mm) 62.3 mm; (g) the length L3 is equal to or approximately equal to (e.g., ±10%, ±5%, or ±1 mm) 75 mm; (h) the length L4 is equal to or approximately equal to (e.g., ±10%, ±5%, or ±1 mm) 80 mm; (i) the length L5 is equal to or approximately equal to (e.g., ±10%, ±5%, or ±1 mm) 20 mm; (j) the stopper 32 has a length L6 equal to or approximately equal to (e.g., ±10%, ±5%, or ±0.3 mm) 10 mm; and / or (k) the stopper 32 has an outer diameter D4 equal to or approximately equal to (e.g., ±10%, ±5%, or ±0.1 mm) 12.4 mm, with or without any coating on the outside of the stopper 32. Any one or any combination of the dimensions (a)-(k) mentioned in the preceding sentence may be preselected.

[0032] By manufacturing a syringe 10 with an outer diameter D1 and / or an inner diameter D2 that is larger than, for example, those specified in ISO 11040-4 for a given volume, it may be possible for the syringe 10 to have a length L1 that is smaller than, for example, those specified in ISO 11040-4 for a given volume. As a result, it may be possible to select a length L1 of the syringe 10 that is suitable for use with a standard syringe tub, such as a syringe tub with a height H equal to or approximately (e.g., ±10% or ±5%) equal to 3 inches (i.e., 76.2 mm). This may enable or facilitate processing of the syringe 10 at many or most existing filling sites or other existing manufacturing facilities, since, for example, standard filling machines and / or other standard manufacturing equipment used in such facilities may be equipped to handle standard syringe tubs, such as a syringe tub with a height H of, for example, 3 inches. As an example, a 3 mL version of syringe 10, if designed to include a standard outer diameter D1 and / or a standard inner diameter D2 as specified in ISO 11040-4, for example, for a 5 mL syringe, as discussed above, may have a length L1 equal to or approximately equal to (e.g., ±10%, ±5%, or ±0.5 mm) 54 mm, and as a result of this length L1, it may be shipped, stored, and / or processed with other similarly sized syringes in a syringe tub having a height H of 3 inches.

[0033] 9-10 show an example of an assembly 50 including a plurality of syringes 10 and a syringe tub 52. The syringe tub 52 may have a plurality of wells for receiving the respective syringes 10 and / or may orient the syringes such that the longitudinal axes A1 of the syringes 10 are parallel or substantially parallel to one another and / or vertical. As an example, the assembly 50 may include a tray 54, the periphery of which rests on a shelf located at the top end of the syringe tub 52, and the tray 54 includes a plurality of openings that define wells. At least a portion of the distal end 14 of each syringe 10 may be inserted into a respective one of the wells, as shown in FIGS. 9-10. At least a portion of the proximal end 16 of each syringe 10 (e.g., flange 18) may be disposed above the tray 54 and / or above an opening in the top of the syringe tub 52, as shown in FIG. 10. As a result, the opening 34 in the proximal shaft of each syringe 10 may be accessible from above, thereby allowing, for example, a fluid dispenser of a filling machine to fill the barrel 16 of the syringe 10 with a drug from above. Although the syringe tub 52 shown in Figures 9-10 is configured to accommodate 36 syringes 10, other configurations of the syringe tub 52 may be configured to accommodate any suitable number of syringes 10. In some embodiments, the entire assembly 50, or at least a portion thereof, may be enclosed within medical grade (e.g., sterile) packaging.

[0034] The syringe tub 52 may have a generally rectangular, square, or any other suitable shape when viewed from above. Additionally, the syringe tub 52 may have a height H, for example, measured between the bottom and top surfaces of the syringe tub 52. By way of example, the height H may be equal to or approximately equal to (e.g., ±10% or ±5%) 3 inches. As discussed above, such height H may be compatible with a wide variety of standard filling machines and / or other standard equipment used in the manufacture of syringes.

[0035] Syringes and methods of manufacturing syringes of the present disclosure are not limited to selecting the particular combinations of dimensions explicitly described herein, and syringes according to the present disclosure may be designed and / or manufactured to include any desired combination of standard syringe dimensions (including, for example, standard syringe dimensions defined in ISO 11040-4) and / or non-standard syringe dimensions.

[0036] Syringes according to the present disclosure may be used in any suitable application and / or may be incorporated into (e.g., placed within) any suitable device. As an example, syringe 10 may be incorporated into a drug delivery device, such as an autoinjector or an internal injector. As a more specific example, the syringe 10 may be incorporated into any of the auto-injectors and other drug delivery devices described in U.S. Patent Application No. 17 / 036,690, filed September 29, 2020, U.S. Patent Application No. 17 / 035,851, filed September 29, 2020, U.S. Patent Application No. 17 / 035,927, filed September 29, 2020, U.S. Patent Application No. 17 / 036,129, filed September 29, 2020, U.S. Patent Application No. 17 / 036,217, filed September 29, 2020, U.S. Provisional Application No. 63 / 159,317, filed March 10, 2021, and U.S. Provisional Application No. 63 / 159,356, filed March 10, 2021, the entire contents of each of which are incorporated by reference.

[0037] All features described in this application, including the specification, claims, abstract, and drawings, and all steps in any method or process described in this application may be combined in any combination, except combinations in which one or more of those features and / or steps are mutually exclusive.

[0038] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used with drugs, including but not limited to the drugs identified below and their generic and biosimilar equivalents. The term drug, as used herein, may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. The drugs may be in liquid form, lyophilized form, or reconstituted from a lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0039] The drug will be contained within a reservoir. In some cases, the reservoir is a primary container into which the drug is either filled or pre-filled for treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0040] In some embodiments, the reservoir of the drug delivery device may be loaded with or the device may be used in conjunction with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0041] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoietin. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin stimulating proteins include erythropoietin, and variants, analogs, or derivatives thereof, which bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0042] Among the specific exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; and proteins that specifically bind to the receptors for IL-4 and / or IL-13. interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., particularly dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, For example, human CD22-specific antibodies, including but not limited to, humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, specifically including but not limited to, human CD22-specific IgG antibodies, such as the human CD22-specific fully humanized antibody of epratuzumab (CAS Registry Number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 anti B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (also referred to as "B7RP-1" and B7H2, ICOSL, B7h, and CD275), including but not limited to fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, which inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins and the like, particularly humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, e.g., 145c7;IFN gamma specific antibodies, peptibodies, related proteins, etc., including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, etc., as well as other TALL specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, etc.; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc., including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc.; TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-beta specific antibodies, peptibodies, related proteins, etc.; amyloid-beta protein specific antibodies, peptibodies, related proteins, etc.; and proteins that bind to c-Kit and / or other stem cell factor receptors. c-Kit specific antibodies, peptibodies, related proteins, etc.; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis stimulating protein quality control (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered trademark (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alpha); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb);Tarceva® (erlotinib);Roferon-A®-(interferon alpha-2a);Simulect® (basiliximab);Prexige® (lumiracoxib);Synagis® (palivizumab);145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507);Tysabri® (natalizumab, anti-α4 integrin mAb);Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb);ABthrax®;Xolair® (omalizumab);ETI211 (anti-MRSA mAb);IL-1 trap (Fc portion of human IgG1 and extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, an anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388; anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;Anti-GDF-8 human mAb (MYO-029);Anti-GM-CSF receptor mAb (CAM-3001);Anti-HepC mAb (HuMax HepC);Anti-IFNα mAb (MEDI-545, MDX-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb; (HuMax-ZP3).

[0043] In some embodiments, the drug delivery device may contain or be used in conjunction with sclerostin antibodies, including but not limited to romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib niphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), including but not limited to TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraine headaches. Antagonistic antibodies against the human calcitonin gene-related peptide (CGRP) receptor, including but not limited to erenumab, and bispecific antibody molecules targeting the human CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell engager (BiTE®) molecules, such as but not limited to BLINCYTO® (blinatumomab), may be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ large molecule agonist, such as but not limited to apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with Avsola™ (infliximab-axxq), an anti-TNF alpha monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), a new bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtib mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the contractile machinery of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS. G12C Small molecule inhibitors, or KRAS G12CIt may contain or be used with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product that contains a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199, or another product containing a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256, or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330, or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain or be used with AMG 427, or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506, or another product containing a multispecific FAP x 4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509, or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology. In some embodiments. In some embodiments, the drug delivery device may contain or be used with AMG 562, or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with ephavalukin alpha (formerly AMG 592), or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596, or another product containing a CD3xEpidermal Growth Factor Receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673, or another product containing a half-life extended (HLE) anti-CD33xanti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0044] The drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. The detailed description should be construed as merely an example, and does not describe all possible embodiments of the present disclosure. Various alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0045] Those skilled in the art will understand that various modifications, alterations, and combinations may be made to the above-described embodiments without departing from the spirit and scope of the present invention disclosed herein, and such modifications, alterations, and combinations are to be construed as being within the scope of the concept of the present invention.

Claims

1. A syringe, a reservoir having a nominal volume of 3 mL or about 3 mL; A wall including a cylindrical portion, the cylindrical portion comprising: An inner diameter equal to or approximately equal to the standard inner diameter of a 5 mL syringe, and Outer diameter equal to or approximately equal to the standard outer diameter of a 5 mL syringe At least one of the following: Wall and A syringe comprising:

2. The syringe according to claim 1, wherein ISO 11040-4 indicates a standard inner diameter of the 5 mL syringe and / or a standard outer diameter of the 5 mL syringe.

3. 3. The syringe of claim 1 or 2, wherein the inner diameter of the cylindrical portion of the wall is equal to or approximately equal to 11.85 mm and / or the outer diameter of the cylindrical portion of the wall is equal to or approximately equal to 14.45 mm.

4. 3. The syringe of claim 1 or 2, wherein the syringe has a first length measured between a proximal inner surface of the wall and a proximal outer surface of the wall.

5. The first length of the syringe is: (a) is less than the standard length of a 3 mL syringe or is less than 72.2 mm, and ISO 11040-4 indicates the standard length of said 3 mL syringe; or (b) equal to or approximately equal to the standard length of a 1 mL syringe or 54 mm, ISO 11040-4 indicating the standard length of said 1 mL syringe; The syringe according to claim 4, wherein

6. 3. The syringe of claim 1 or 2, wherein the syringe has a second length measured between a distal outer surface of the wall and a proximal outer surface of the wall, the second length being equal to or approximately equal to 62.3 mm.

7. The syringe of claim 1, wherein the syringe has a needle and the syringe has a third length measured between a distal outer surface of the needle and a proximal outer surface of the wall, the third length being equal to or approximately equal to 75 mm.

8. A syringe as described in claim 7, further comprising a removable sterile barrier covering at least a portion of the needle, the syringe having a fourth length measured between a distal outer surface of the removable sterile barrier and a proximal outer surface of the wall, the fourth length being equal to or approximately equal to 80 mm.

9. 8. The syringe of claim 7, wherein the syringe has a fifth length measured between a distal outer surface of the removable sterility barrier and a proximal outer surface of the removable sterility barrier, the fifth length being equal to or approximately equal to 25.1 mm.

10. The syringe of claim 1, further comprising a stopper at least partially disposed within the cylindrical portion of the wall, a sixth length measured between a distal surface of the stopper and a proximal surface of the stopper, the sixth length being equal to or approximately equal to 10 mm.

11. A method for producing a syringe having a nominal capacity, comprising the steps of: preparing or obtaining a standard syringe dimension specification, the specification indicating, for each of a plurality of syringe capacities, at least (a) one of a plurality of standard diameters, and (b) one of a plurality of standard lengths; selecting a standard diameter from among the plurality of standard diameters included in the specification, wherein the syringe capacity indicated by the specification for the selected standard diameter is not equal to the nominal capacity; The method includes:

12. 12. The method of claim 11, wherein the nominal volume is 3 mL.

13. 13. The method of claim 11 or 12, wherein the syringe capacity indicated by the specifications for the selected standard diameter is (a) 5 mL; and / or (b) greater than the nominal capacity.

14. The method further comprising selecting a length for the syringe, wherein the selected length (a) is not equal to the standard length indicated by the specification for the nominal capacity; (b) is shorter than the standard length indicated by the specification for the nominal capacity; (c) is equal to or approximately equal to the standard length indicated by the specification for a 1 mL syringe; and / or (d) is calculated according to a mathematical formula, wherein the selected length is: [0010] The method of claim 11 , wherein the ΔT is equal to or approximately equal to

15. The method of claim 11 or 12, wherein the standard syringe dimensional specifications include ISO 11040-4.

16. 13. The method of claim 11 or 12, wherein the plurality of standard diameters corresponds to a plurality of standard outer diameters of the syringe and / or a plurality of standard inner diameters of the syringe.

17. 1. An assembly for use in at least a filling process, said assembly comprising: A tub-type container; and a plurality of syringes each disposed at least partially within the tub, one or more of the syringes comprising: A needle inserted into the syringe; a reservoir filled or configured to be filled with a 3 mL dose of a drug or about a 3 mL dose of said drug; Shorter length compared to standard length for 3mL syringes An assembly comprising:

18. 18. The assembly of claim 17, wherein the tub has a height equal to or approximately equal to 3 inches or 76.2 mm.

19. 19. The assembly of claim 17 or 18, wherein one or more of the syringes have an outer and / or inner diameter equal to or approximately equal to the standard outer diameter of a 5 mL syringe.

20. 19. The assembly of claim 17 or 18, wherein one or more of the syringes have a length equal to or approximately equal to a standard length of a 1 mL syringe.

21. A syringe comprising: a reservoir filled or configured to be filled with a 3 mL dose of a drug or about a 3 mL dose of said drug; A wall including a cylindrical portion, the cylindrical portion comprising: An inner diameter equal to or approximately equal to the standard inner diameter of a 5 mL syringe, and Outer diameter equal to or approximately equal to the standard outer diameter of a 5 mL syringe a wall having at least one of: A flange at the proximal end of the syringe and Equipped with The outer diameter of the flange of the syringe is 18 mm ± 0.9 mm.

22. The syringe of claim 21, wherein a distal end of the syringe includes a needle.

23. The syringe of claim 21, wherein ISO 11040-4 indicates the standard inner diameter of a 5 mL syringe and / or the standard outer diameter of a 5 mL syringe.

24. A syringe as described in claim 21, wherein the inner diameter of the cylindrical portion of the wall is equal to or approximately equal to 11.85 mm, and / or the outer diameter of the cylindrical portion of the wall is equal to or approximately equal to 14.45 mm.

25. A syringe comprising: a reservoir filled or configured to be filled with a 3 mL dose of a drug or about a 3 mL dose of said drug; A wall including a cylindrical portion, the cylindrical portion comprising: An inner diameter equal to or approximately equal to the standard inner diameter of a 5 mL syringe, and Outer diameter equal to or approximately equal to the standard outer diameter of a 5 mL syringe A wall and A syringe comprising:

Images