Temperature indicator for drug delivery device

Abstract

To provide drug delivery devices having temperature indicator assemblies to assist with drug administration.SOLUTION: A drug delivery device 100 includes a housing 102, a container 110 disposed in the housing, an activation mechanism 120, a needle assembly 130, and a temperature indicator 150. The housing defines an inner volume and includes at least one opening 104. The container contains a medicament 101 which is urged out of the container by the activation mechanism. The needle assembly has a needle and / or a cannula 132 to deliver the medicament from the container. The temperature indicator is operably coupled with an outer surface 110a of the container and is responsive to a change in temperature of the container.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 62 / 912,462, filed October 8, 2019, and U.S. Provisional Patent Application No. 62 / 936,082, filed November 15, 2019, the entire contents of each of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery devices, and more particularly to drug delivery devices having a temperature indicator assembly for assisting in drug administration. [Background technology]

[0003] Drug delivery devices, such as injectors, are used to deliver liquid medication to patients. When activated, the drug delivery device can expel a drug stored in an internal reservoir of a primary container through a needle, cannula, or other delivery member into the patient. Some drug delivery devices can be temporarily attached to a patient to deliver the drug over an extended period of time via an injection needle or other means. The drug delivery device can be adhesively attached to tissue in the patient's abdomen, thigh, arm, or other part of the patient's body.

[0004] Many medications require refrigeration to maintain stability and efficacy. Therefore, these medications are typically labeled to be kept cold during the manufacturing, transportation, and storage processes prior to patient and / or clinician use. These medications are often stored at temperatures ranging from approximately 2°C to approximately 8°C to accommodate a standard home refrigerator and must be thoroughly warmed before administration to minimize pain and ensure the delivery device functions properly and as intended. Patients may be hesitant to administer these medications due to warming techniques, which can pose a risk of administering a cold infusion or requiring extended delivery times if the patient fails to wait an appropriate amount of time after removing the device from refrigeration. These factors, which can increase the perceived duration of the infusion and user discomfort, may pose a risk of decreased adherence to treatment.

[0005] Patients desire both a comfortable and predictable injection experience. Administering an injection using a device of substantially similar temperature often results in a substantially similar experience. Particularly for drugs with highly temperature-dependent viscosity, a difference in drug temperature of about 5°C or more at the time of administration is likely to result in a discernible difference to the patient. This can lead to hesitation and uncertainty in administering the next dose. This, in turn, can lead to lower levels of adherence.

[0006] As described in more detail below, the present disclosure describes a system for a delivery device that embodies an advantageous alternative to existing systems and methods, which may address one or more of the problems or needs described herein as well as provide other benefits and advantages. Summary of the Invention [Means for solving the problem]

[0007] According to a first aspect, a drug delivery device includes a housing, a container disposed within the housing, an activation mechanism, a needle assembly, and a temperature indicator. The housing defines an interior volume and includes at least one opening. The container contains a medication that is expelled from the container by the activation mechanism. The needle assembly has a needle and / or cannula for delivering the medication from the container. The temperature indicator is operatively coupled to an exterior surface of the container and is responsive to temperature changes of the container. In some approaches, the temperature indicator is in the form of a reversible thermochromic sensor having a first operating temperature range.

[0008] In some examples, the drug delivery device may further include a window adapted to cover the at least one opening. The window may be a magnifying window. Further, in some examples, the window may be coupled to a temperature display.

[0009] In these and other examples, the drug delivery device may further include an insulating member disposed around an exterior sidewall of the temperature indicator, the insulating member thermally insulating the temperature indicator from the housing.

[0010] In some embodiments, the temperature indicator is made from a material having a high thermal conductivity. Additionally, the temperature indicator may be in the form of a label that at least partially surrounds the exterior surface of the container.

[0011] In some examples, the drug delivery device may include multiple temperature indicators, each of which may have a different operating temperature range.

[0012] In some forms, the drug delivery device may include a thermally conductive material disposed between the container and the temperature indicator.

[0013] According to a second aspect, a method of assembling a drug delivery device includes providing a housing defining an internal volume and including at least one opening. A container is at least partially disposed within the housing. The container has an exterior surface and contains a medicament. An activation mechanism and a needle assembly are also at least partially disposed within the housing. The activation mechanism is adapted to apply a force to expel the medicament from the container. The needle assembly is operatively coupled to the activation mechanism and includes a needle and / or cannula for delivering the medicament. A temperature sensor is thermally coupled to the exterior surface of the container. The temperature sensor is responsive to changes in temperature of the container.

[0014] The above needs are met, at least in part, by the provision of a temperature indicator for a drug delivery device as described in the detailed description below, particularly when studied in conjunction with the drawings.

[0015] The accompanying drawings illustrate embodiments in accordance with the present disclosure and are by way of example rather than limitation. [Brief explanation of the drawings]

[0016] [Figure 1] 1A-1D show schematic diagrams of exemplary configurations of drug delivery devices with temperature indicators according to various embodiments. [Figure 2] 2 shows a front view of the exemplary drug delivery device of FIG. 1 in accordance with various embodiments. [Figure 3] FIG. 1 shows a front view of a second exemplary drug delivery device according to various embodiments. [Figure 4] 3 shows a side elevation view of the exemplary drug delivery device of FIG. 2 in accordance with various embodiments. [Figure 5] 4 shows a cross-sectional view of the exemplary drug delivery device of FIGS. 2 and 3 taken along line AA' in accordance with various embodiments. [Figure 6] FIG. 10 shows a side elevation view of a third exemplary drug delivery device according to various embodiments. [Figure 7] 7 shows a cross-sectional view of the exemplary drug delivery device of FIG. 6 taken along line AA' in accordance with various embodiments. [Figure 8] 10 shows a cross-sectional view of a fourth exemplary drug delivery device according to various embodiments. [Figure 9] 10 shows a front view of a fifth exemplary drug delivery device according to various embodiments. [Figure 10] 10 shows a side elevation view of the exemplary drug delivery device of FIG. 9 in accordance with various embodiments. [Figure 11] 11 shows a cross-sectional view of the exemplary drug delivery device of FIGS. 9 and 10 taken along line AA' in accordance with various embodiments. [Figure 12] 10 shows a front view of a sixth exemplary drug delivery device according to various embodiments. [Figure 13] FIG. 10 shows a front view of a seventh exemplary drug delivery device according to various embodiments. [Figure 14] FIG. 10 shows a front view of an eighth exemplary drug delivery device in a first operating state according to various embodiments. [Figure 15] 15 shows a front view of the exemplary drug delivery device of FIG. 14 in a second operating state according to various embodiments. [Figure 16] 16 shows a front view of the exemplary drug delivery device of FIGS. 14 and 15 in a third operational state according to various embodiments. FIG. [Figure 17] FIG. 10 shows a front view of a ninth exemplary drug delivery device in a first operating state according to various embodiments. [Figure 18] FIG. 18 shows a front view of the exemplary drug delivery device of FIG. 17 in a second operational state according to various embodiments. [Figure 19] 18 shows a front view of the exemplary drug delivery device of FIGS. 16 and 17 in a third operational state according to various embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0017] Those skilled in the art will understand that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially feasible embodiments are often not shown in order to unduly distract from the illustrations of these various embodiments. Furthermore, it will be appreciated that certain acts and / or steps may be described or shown in a particular chronological order, although those skilled in the art will understand that such specificity with respect to order is not actually required. It will also be understood that the terms and phrases used herein have the ordinary technical meaning, as set forth above, that would be ascribed to such terms and phrases by those skilled in the art, unless a different specific meaning is explained herein.

[0018] The present disclosure generally relates to a temperature indicator for a drug delivery device that provides a visual indication to a user when the drug delivery device has reached a temperature suitable for drug administration. Injectable drugs are typically stored in a cooling device, such as a refrigerator, at a temperature ranging from about 2°C to about 8°C. Patients are encouraged to wait until the drug has increased in temperature before administering the drug to aid in administration comfort. The drug delivery device described herein, and more specifically, the temperature indicator, provides an accurate visual indication as to when the drug has reached a temperature suitable for injection.

[0019] Referring to the figure, a generic drug delivery device 100 in the form of an autoinjector is provided having a vertically oriented configuration in which some or all of the drug delivery components are disposed in a stacked relationship along a longitudinal axis L within a housing 102 of the drug delivery device 100. As a more specific example, the device 100 may be configured to operate and inject into a user with the device 100 oriented substantially perpendicular to the user's skin surface. The drug delivery device 100 may include the aforementioned housing 102 defining an interior volume 102a and at least one opening 104, a reservoir 110, an actuation mechanism 120, a needle assembly 130, and a temperature indicator 150, each of which is at least partially disposed within the interior volume 102a of the housing 102.

[0020] In some embodiments, including that shown in FIG. 1 , drug delivery device 100 may be configured as an auto-injector or pen injector. In other embodiments, drug delivery device 100 may be in the form of any other type of handheld device, including a combined handheld device, a wearable drug delivery device such as an on-body injector, or a portable infusion pump that may be removably coupled to a patient, or a combination thereof. Drug delivery device 100 may be operated to deliver a drug to a patient subcutaneously or transdermally. Drug delivery device 100 may be configured to automatically deliver a fixed or patient / operator-settable dose of a drug for a fixed and / or patient / operator-settable time period. Drug delivery device 100 may be intended for self-administration by a patient or, in some instances, may be used by a caregiver or healthcare provider formally trained to administer injections.

[0021] Container 110 includes an exterior surface 110a and an interior volume 112. Container 110 (which may be referred to in some instances as a primary container) further houses a piston 114 within its interior volume 112. Piston 114 is movably disposed within container 110 along a longitudinal axis "L" and has a first end 114a that includes an interior surface 115. The interior surface of container 110 and the interior surface 115 of piston 114 define a reservoir for containing drug or medicament 101. Generally, at least one opening 104 is aligned with container 110 to allow a user to view at least a portion of exterior surface 110a of container 110 before, during, and after drug administration to complete a visual inspection and / or determine the amount of drug and / or medicament 101 remaining.

[0022] The amount of drug 101 contained in the reservoir prior to delivery can be any amount within the range of about (e.g., ±10%) 0.5 to 20 mL, or any amount within the range of about (e.g., ±10%) 0.5 to 10 mL, or any amount within the range of about (e.g., ±10%) 1 to 10 mL, or any amount within the range of about (e.g., ±10%) 1 to 8 mL, or any amount within the range of about (e.g., ±10%) 1 to 5 mL, or any amount within the range of about (e.g., ±10%) 1 to 3.5 mL, or any amount within the range of about (e.g., ±10%) 1 to 3 mL, or any amount within the range of about (e.g., ±10%) 1 to 2.5 mL, or any amount within the range of about (e.g., ±10%) The reservoir may be any volume within the range of 1-2 mL, or any volume up to about (e.g., ±10%) 4 mL, or any volume up to about (e.g., ±10%) 3.5 mL, or any volume up to about (e.g., ±10%) 3 mL, or any volume up to about (e.g., ±10%) 2.5 mL, or any volume up to about (e.g., ±10%) 2 mL, or any volume up to about (e.g., ±10%) 1.5 mL, or any volume up to about (e.g., ±10%) 1 mL, or any volume up to about (e.g., ±10%) 2 mL, or any volume up to about (e.g., ±10%) 2.5 mL, or any volume up to about (e.g., ±10%) 3 mL. The reservoir may be fully or partially filled with the drug or agent 101. The drug or agent 101 may be one or more of the drugs listed below under the heading "Drug Information," such as, for example, granulocyte colony-stimulating factor (G-CSF), PCSK9 (proprotein convertase subtilisin / kexin type 9)-specific antibody, sclerostin antibody, or calcitonin gene-related peptide antibody (CGRP).

[0023] The actuation mechanism 120 is coupled to the piston rod 122 for driving the piston 114 within the container 110. The actuation mechanism 120 may be in the form of any number of suitable components capable of exerting a force to expel the drug or medication 101 from the container 110. In some examples, the actuation mechanism 120 may include a user input device 124, such as a button, that may be engageable by a user to initiate drug delivery. In some examples, the drug delivery device 100 may include a controller 126 in electrical and / or mechanical communication with the user input device 124 to control the operation of the actuation mechanism 120.

[0024] The needle assembly 130 is operatively coupled to an actuation mechanism 120 for inserting the needle and / or cannula 132 to deliver the drug or agent 101. More specifically, the needle assembly 130 includes the needle and / or cannula 132 oriented along a longitudinal axis L, a fluid path 134 fluidly coupling the reservoir to the needle and / or cannula 132, and an actuation assembly 136 configured to insert the needle and / or cannula 132 to a desired subcutaneous depth within the user. In some approaches, the actuation assembly 136 may be a retractable needle guard to expose the needle and / or cannula 132 or a drive mechanism to move the needle and / or cannula 132 longitudinally a desired distance.

[0025] In some examples, the actuation mechanism 120 may be configured to drive movement of both the piston 114 and the needle and / or cannula 132 by moving any combination of the reservoir 110, the flow path 134, and / or the needle and / or cannula 132. As generally configured, one or more of the components of the device 100, such as the drive mechanism 108 and the needle insertion mechanism 116, may be operable in response to actuation of a user input device 124 accessible outside the housing 102. Suitable actuation mechanisms 120 include, but are not limited to, a spring, a gas source, a phase change material, a motor, or other electromechanical system. As previously mentioned, the controller 126 may control the operation of one or more of the drug delivery components.

[0026] 1 depicts the components centrally disposed along the longitudinal axis L, it will be understood that one or more of the components can be disposed off-center from the longitudinal axis L within the housing 102 and still be considered to be in a stacked relationship. In one example, an autoinjector drug delivery device having drug delivery components in a stacked relationship corresponds to a reservoir 110 coaxially aligned with a needle and / or cannula 132. Examples of suitable autoinjector devices are described in U.S. Patent Application No. 62 / 447,174, filed January 17, 2017, which is incorporated herein by reference.

[0027] The temperature indicator 150 may be in the form of a reversible thermochromic sensor that changes its visual properties in response to temperature changes. More specifically, the temperature indicator 150 may be in the form of a liquid crystal and / or leuco dye element thermally coupled to the exterior surface 110a of the container 110. In some examples, the temperature indicator 150 may be in the form of a disc element directly attached and / or adhered to the exterior surface 110a of the container 110. In other examples, the temperature indicator 150 may be in the form of a label, strip, or painted element attached to the container 110. The temperature indicator 150 or label may be made from polypropylene, polyester, LD polyethylene, polyolefin, paper, vinyl, and / or combinations thereof. The temperature-responsive component may be a water-based ink, a solvent-based ink, or any combination thereof. Other suitable examples of materials are also possible. The temperature indicator 150 may be made from a material with high thermal conductivity and elastomeric properties so that it provides high thermal responsiveness through physical contact with the container 110.

[0028] In some examples, temperature indicator 150 may be responsive to a specified temperature range, such as, for example, an administration temperature of about 15°C to about 35°C, preferably about 22°C to about 28°C. Other suitable example temperature ranges are possible. In some examples, temperature indicator 150 may be a first color and / or pattern (e.g., substantially transparent) when exposed to a low temperature and transition to a second color and / or pattern (e.g., green) when exposed to a higher temperature appropriate for drug administration. In some examples, temperature indicator 150 may change color in the reverse manner.

[0029] 1 and 2, in a first embodiment of the drug delivery device 100, the temperature indicator 150 is coupled to and positioned on the exterior surface 110a of the container. The temperature indicator 150 is positioned with the opening 104 so that a user can look through the opening 104 and recognize the color of the temperature indicator 150 (as well as observe whether the drug or medication 101 contains particulates, discoloration, and / or abnormalities) and therefore recognize whether the drug or medication 101 is at the proper administration temperature. Such a configuration advantageously provides proximity to the drug or medication 101. More specifically, because the temperature indicator 150 is thermally coupled to the container 110, when the temperature of the container 110 increases due to removal from the refrigeration unit, the temperature indicator 150 reflects the increase in temperature by changing color.

[0030] A second embodiment of a drug delivery device 200 including a temperature display 250 is shown in Figures 3-5. It will be understood that the drug delivery device 200 shown in Figures 3-5 may include similar features to the drug delivery device 100, and therefore the elements shown in Figures 3-5 are designated by similar reference numerals to those shown in the embodiment shown in Figures 1 and 2, increased by 100. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to the drug delivery device 100 may be incorporated into the drug delivery device 200.

[0031] In this embodiment, the housing 202 includes a separate opening 204 for specifically viewing the temperature indicator 250. In other words, the housing 202 includes the aforementioned opening 204 that can be used to visually inspect the container 210 and the drug or medication 201 contained therein, as well as an additional opening 204' that is used to provide visual access to the temperature indicator 250. The opening 204' can be positioned approximately 90° from one or more openings 204, although other suitable positions are possible. Furthermore, it will be appreciated that the cross-sectional shape, size, and / or thickness of the temperature indicator 250 (and thus each opening 204') can be customized depending on the design of the drug delivery device 200 and the location of the container 210 within the housing 202.

[0032] During preparation of the drug delivery device 200, care must be taken to ensure that the visual indicator 250 is properly aligned with the opening 204'. By using a separate opening 204', the remaining opening or openings 204 may be visually unobstructed and accessible for inspection.

[0033] A third embodiment of a drug delivery device 300 including a temperature display 350 is shown in Figures 6 and 7. It will be understood that the drug delivery device 300 shown in Figures 6 and 7 may include similar features to drug delivery devices 100, 200, and therefore the elements shown in Figures 6 and 7 are designated by similar reference numerals to those shown in the embodiments shown in Figures 1-5, increased by 100 or 200. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to drug delivery device 100 and / or drug delivery device 200 may be incorporated into drug delivery device 300.

[0034] In this embodiment, the temperature display 350 further includes a thermal insulation layer 352 disposed along the sidewall 351 of the temperature display 350. The thermal insulation layer 352 provides thermal insulation from the housing 302 and helps to provide an isothermal path between the exterior surface 310a of the container 310 and the visually exposed surface of the temperature display 350. The thermal insulation layer 352 may be made from a number of materials capable of trapping single or multiple air pockets, such as, for example, woven fabric, fiberglass, fluoropolymer, foam, polyethylene, polypropylene, polystyrene, polyester, polyimide, poly(ethylene terephthalate), or polyolefin. Other suitable materials may also be used. As previously mentioned, the temperature display 350 may be made from a material having high thermal conductivity and elastomeric properties.

[0035] A fourth embodiment of a drug delivery device 400 including a temperature display 450 is shown in Figure 8. It will be understood that drug delivery device 400 shown in Figure 8 may include features similar to drug delivery devices 100, 200, and 300, and therefore elements shown in Figure 8 are designated by similar reference numerals to those shown in the embodiments shown in Figures 1-7, plus 100, 200, or 300. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to drug delivery device 100, drug delivery device 200, and / or drug delivery device 300 can be incorporated into drug delivery device 400.

[0036] In this embodiment, the temperature display 450 further includes a window member 456 made from a transparent and / or translucent material. In this example, the window member 456 is coupled to and abuts the temperature display 450. Any changes in color and / or pattern of the temperature display 450 can be seen through the window member 456. As mentioned above, the materials, shapes, and / or configurations of the temperature display 450 and the window member 456 can be selected to ensure that the temperature display 450 is in physical contact with the exterior surface 410a of the container 410.

[0037] A fifth embodiment of a drug delivery device 500 including a temperature display 550 is shown in Figures 9-11. It will be understood that drug delivery device 500 shown in Figures 9-11 may include features similar to drug delivery devices 100, 200, 300, and 400, and therefore the elements shown in Figures 9-11 are designated by similar reference numerals to those shown in the embodiments shown in Figures 1-8 plus 100, 200, 300, or 400. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to drug delivery device 100, drug delivery device 200, drug delivery device 300, and / or drug delivery device 400 may be incorporated into drug delivery device 500.

[0038] In this embodiment, the temperature display portion 550 further includes a window member 556 made from a transparent and / or translucent material. However, in this example, the window member 556 is positioned so as to be substantially flush with the housing 502 to reduce and / or eliminate a recess formed in the opening 504′. The window member 556 may be in the form of a magnifying window that can assist a user in viewing the temperature display portion 550 through the opening 504′. As mentioned above, the cross-sectional shape, size, and / or thickness of the temperature display portion 550, the window member 556, and their relative positions may be adjusted depending on the design of the drug delivery device 500.

[0039] A sixth embodiment of a drug delivery device 600 including a temperature indicator 650 is shown in Figure 12. It will be understood that drug delivery device 600 shown in Figure 12 may include features similar to drug delivery devices 100, 200, 300, 400, and 500, and therefore the elements shown in Figure 12 are designated by similar reference numerals to those shown in the embodiments shown in Figures 1-11 plus 100, 200, 300, 400, or 500. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to drug delivery device 100, drug delivery device 200, drug delivery device 300, drug delivery device 400, and / or drug delivery device 500 may be incorporated into drug delivery device 600.

[0040] In this embodiment, the temperature display 650 is in the form of a strip that completely surrounds a portion of the exterior surface 610a of the container 610. Thus, the container 610, and therefore the temperature display 650, need not be aligned with a particular opening 604 to allow a user to view the temperature display 650. Although not shown in FIG. 12 , the housing 602 may include additional openings for specifically viewing the temperature display 650.

[0041] A seventh embodiment of a drug delivery device 700 including a temperature display 750 is shown in Figure 13. It will be understood that drug delivery device 700 shown in Figure 13 may include features similar to drug delivery devices 100, 200, 300, 400, 500, and 600, and therefore the elements shown in Figure 13 are designated by similar reference numerals to those shown in the embodiments shown in Figures 1-12 plus 100, 200, 300, 400, 500, or 600. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to drug delivery device 100, drug delivery device 200, drug delivery device 300, drug delivery device 400, drug delivery device 500, and / or drug delivery device 600 may be incorporated into drug delivery device 700.

[0042] In this embodiment, the temperature indicator 750 is in the form of a label affixed to the exterior surface 710a of the container 710. Such a label may be affixed to the container 710 during the manufacturing process.

[0043] An eighth embodiment of a drug delivery device 800 including a temperature indicator 850 is shown in Figures 14-16. It will be understood that drug delivery device 800 shown in Figures 14-16 may include features similar to drug delivery devices 100, 200, 300, 400, 500, 600, and 700, and therefore the elements shown in Figures 14-16 are designated by similar reference numerals to those shown in the embodiment shown in Figures 1-13 plus 100, 200, 300, 400, 500, 600, or 700. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to drug delivery device 100, drug delivery device 200, drug delivery device 300, drug delivery device 400, drug delivery device 500, drug delivery device 600, and / or drug delivery device 700 may be incorporated into drug delivery device 800.

[0044] In this embodiment, the temperature display 850 is in the form of a progressive display. More specifically, in the illustrated example, the temperature display 850 includes a first temperature display 850a, a second temperature display 850b, and a third temperature display 850c. Each of the temperature display 850a, 850b, and 850c has a different temperature response range. More specifically, the first temperature display 850a is configured to function as a "control" that provides a visual indication of what the temperature display 850 will look like when changing to a second color or pattern. Thus, the first temperature display 850a may be configured not to respond to temperature changes that occur during typical use of the device 800.

[0045] Second temperature display 850b may be responsive to a second temperature range. For example, second temperature display 850b may change color and / or pattern when outer surface 810a of container 810 (and therefore drug or medication 801) is between about 10°C and about 16°C. Third temperature display 850c may be responsive to a third temperature range. For example, third temperature display 850c may change color and / or pattern when outer surface 810a of container 810 (and therefore drug or medication 801) is between about 18°C ​​and about 20°C.

[0046] Thus, as shown in FIG. 14, when the temperature of the drug delivery device 800 remains below about 9°C, only the first temperature indicator 850a exhibits a "change" in color and / or pattern. As shown in FIG. 15, when the drug delivery device 800 is warmed to a temperature of about 10°C to about 16°C, the second temperature indicator 850b changes to the same color and / or pattern as the first temperature indicator 850a. As shown in FIG. 16, when the drug delivery device 800 is warmed to a temperature of about 18°C ​​to about 20°C, the third temperature indicator 850c changes to the same color and / or pattern as the first temperature indicator 850a and the second temperature indicator 850b. In some examples, the first temperature indicator 850a may not be used.

[0047] A ninth embodiment of a drug delivery device 900 including a temperature indicator 950 is shown in Figures 17-19. It will be understood that drug delivery device 900 shown in Figures 17-19 may include features similar to drug delivery devices 100, 200, 300, 400, 500, 600, 700, and 800, and therefore, the elements shown in Figures 17-19 are designated by similar reference numerals to those shown in the embodiment shown in Figures 1-16 plus 100, 200, 300, 400, 500, 600, 700, or 800. Accordingly, these features will not be described in great detail. Furthermore, it will be recognized that any of the elements described with respect to drug delivery device 100, drug delivery device 200, drug delivery device 300, drug delivery device 400, drug delivery device 500, drug delivery device 600, drug delivery device 700, and / or drug delivery device 800 may be incorporated into drug delivery device 900.

[0048] In this embodiment, the temperature display 950 is also in the form of a progressive display. In this example, the first temperature display 950a, the second temperature display 950b, and the third temperature display 950c are elongated strips and / or labels wrapped around the exterior surface 910a of the container 910.

[0049] Because the temperature of the container may not necessarily be equal to the temperature of the housing, configured in this manner, the temperature display described can more accurately identify a temperature by thermally coupling the temperature display to the container as opposed to the housing. Additionally, this design reduces and / or eliminates the possibility of a user unintentionally touching the temperature display, which may result in an erroneous temperature reading.

[0050] It will be appreciated that the drug delivery device and temperature indicator may include any number of suitable alternatives. For example, although not shown, an alternative drug delivery device may incorporate a temperature indicator coupled to a conductive material that itself contacts the container. Such a configuration may facilitate implementation and use. In some examples, a thermally conductive material, which may be in the form of a metallic member, is molded into the device housing and connected to the container.

[0051] Additionally, in some examples, the temperature sensor may be positioned to be located at or near the piston to reduce any visual obstructions that may prevent the user from viewing the medication or agent within the container.

[0052] 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 in conjunction with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may refer to any type of pharmaceutical or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0053] The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is either filled or pre-filled with the drug for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0054] In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, a colony-stimulating factor 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-Met-G-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006, pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0055] In other embodiments, the drug delivery device may contain or be used in conjunction with an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates red blood cell production. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-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. Erythropoiesis-stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that 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. Erythropoiesis-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), and 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.

[0056] Among certain 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, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, and related proteins, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to their receptors. 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., especially dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g., the human form of epratuzumab (CAS Registry Number 501423-23-0). 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, particularly including but not limited to, human CD22-specific IgG antibodies, such as CD22-specific fully humanized antibodies; IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, and related proteins (also referred to as "B7RP-1," B7H2, ICOSL, B7h, and CD275), including but not limited to, those that inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1 on activated T cells, including but not limited to, a B7RP-specific fully human monoclonal IgG2 antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1; HuMax, e.g., 145c7 IL-15 specific antibodies, peptibodies, related proteins, etc., including, but not limited to, IL-15 antibodies and related proteins, particularly humanized monoclonal antibodies; human IFNIFN-γ-specific antibodies, peptibodies, related proteins, etc., including but not limited to, IFN-γ-specific antibodies, and fully human anti-IFN-γ antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, etc.; and those targeting the hepatocyte growth factor / scatter factor (HGF / SF:c-Met) axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize HGF / SF. including, 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-β-specific antibodies, peptibodies, related proteins, etc.; amyloid β protein-specific antibodies, peptibodies, related proteins, etc.; c-Kit-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind to X40L 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 (NESP), Epogen (R) (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-alpha4beta7mAb), 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 cancer or gastric cancer, Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), (panitumumab), Vectibix® (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-BlySmAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), 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 alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP IIb / IIia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Mvasi™ (bevacizumab-awwb), Rituxan® (rituximab, anti-CD20mAb), 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-alpha4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (the Fc portion of human IgG1 and the extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (VEGFR1 Ig domain fused to IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, 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), CNTO148 (golimumab, anti-TNFα mAb), HGS-ETR1 (mapatumumab, 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 mAb, anti-Clostridium difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (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 (HuMaxAnti-CD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF-Idiopathic Pulmonary Disease Stage 1 Follicular Genome (FG-3019), anti-CTLA4 mAb, anti-eotactic-signal 1 mAb (CAT-213), anti-FGF8 mAb, anti-GD2 mAb, anti-GM2 mAb, anti-GDF-8 receptor 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 (CNTO1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 receptor mAb, anti-Ig receptor mAb (MDX-018, CNTO95), anti-IP10 ulcerative colitis mAb (MDX-1100), BMS-66513, anti-mannos receptor / hCGβ mAb (MDX-1307), anti-metastatic 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 mAb (HGS-ETR2), anti-TWEAK mAb, anti-VEGFR / Flt-1 mAb, and anti-ZP3 mAb (HuMax-ZP3).

[0057] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, BPS804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing; or, in other embodiments, a monoclonal antibody (IgG) that binds 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 diphosphate, 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, OncoVEX GALV / 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), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may contain, or be used in conjunction with, Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules that target the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.Additionally, bispecific T cell engager (BiTE®) antibodies, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction 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 in conjunction with Avsola™ (infliximab-axxq), an anti-TNFα 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) undergoing hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP798 (rituximab), a biosimilar candidate for 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 inhibitor, such as a non-antibody VEGF inhibitor, and / or a VEGF trap, such as aflibercept (fused to Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2, Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP959 (eculizumab), a biosimilar candidate for 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 in conjunction with rozivacsp alfa (formerly AMG570), a novel bispecific antibody-peptide conjugate that simultaneously inhibits the activity of ICOSL and BAFF. In some embodiments, the drug delivery device may contain or be used in conjunction with omecamtiv mecarbil (a small molecule selective cardiac myosin activator) or a myotrope (which directly targets the cardiac contractile machinery) or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used in conjunction with sotorasib (formerly known as AMG510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used in conjunction 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 in conjunction with AMG714, a human monoclonal antibody that binds interleukin-15 (IL-15), or another product containing a human monoclonal antibody that binds interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used in conjunction with AMG890, a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP654 (a human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product containing a human IgG1 kappa antibody and / or that 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 another product containing Amjevita™ or Amgevita™ (formerly ABP501) (monoclonal antibody anti-TNF human IgG1), a biosimilar candidate for Humira®, or a human monoclonal antibody anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with another product containing AMG160 or a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG119 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 AMG119 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 in conjunction with another product containing AMG133, 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 in conjunction with another product containing AMG171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG199, or a half-life extended (HLE) bispecific T cell derivative construct (BiTE®). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG256, an anti-PD-1xIL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on 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 in conjunction with another product containing AMG330, an anti-CD33xanti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG404, 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 in conjunction with another product containing AMG427, a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3)xanti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG430 or another product containing an anti-Jagged-1 monoclonal antibody.In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG506, a multispecific FAPx4-1BB-targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG509, a bivalent T cell derivative designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG562, a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with efabaleukin alfa (formerly AMG592), or a product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG509, a bivalent T cell derivative designed using XmAb® 2+1 technology. The drug delivery device may contain or be used in conjunction with another product containing AMG596 or a CD3x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell derivative) molecule. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG673 or a half-life extended (HLE) anti-CD33x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG701 or a half-life extended (HLE) anti-B cell maturation antigen (BCMA)x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG757 or a half-life extended (HLE) anti-delta-like ligand 3 (DLL3)x anti-CD3 BiTE® (bispecific T cell derivative) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG910 or another product containing the half-life extended (HLE) epithelial cell tight junction protein claudin 18.2xCD3 BiTE® (bispecific T cell derivative) construct.

[0058] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited to the exemplary embodiments. The detailed description should be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0059] Those skilled in the art will appreciate that numerous modifications, variations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, variations, and combinations are to be construed as being within the scope of the inventive concept.

Claims

1. a housing defining an interior volume and including at least one opening; a container disposed at least partially within the housing, the container having an exterior surface and containing a medicament; an actuation mechanism at least partially disposed within the housing, the actuation mechanism adapted to exert a force to expel the medicament from the container; a needle assembly having a needle and / or cannula for delivering the medicament; a temperature indicator thermally coupled to the exterior surface of the container, the temperature indicator responsive to changes in the temperature of the container; 1. A drug delivery device comprising:

2. The drug delivery device of claim 1 , wherein the temperature indicator includes a reversible thermochromic sensor having a first operating temperature range.

3. The drug delivery device of claim 1 or 2, further comprising a window adapted to cover the at least one opening.

4. The drug delivery device of claim 3 , wherein the window comprises a magnifying window.

5. 5. The drug delivery device of claim 3, wherein the window is coupled to the temperature display.

6. The drug delivery device of any one of claims 1 to 5, further comprising an insulating member disposed around an outer side wall of the temperature display portion such that the insulating member thermally insulates the temperature display portion from the housing.

7. The drug delivery device according to any one of claims 1 to 6, wherein the temperature indicator is made of a material having high thermal conductivity.

8. The drug delivery device of any one of claims 1 to 7, wherein the temperature indicator is in the form of a label at least partially surrounding the exterior surface of the container.

9. The drug delivery device of any one of claims 1 to 8, further comprising a plurality of temperature display units, each of the plurality of temperature display units having a different operating temperature range.

10. The drug delivery device according to any one of claims 1 to 9, further comprising a thermally conductive material, the thermally conductive material being disposed between the container and the temperature display portion.

11. 1. A method of assembling a drug delivery device, comprising: providing a housing defining an interior volume and including at least one opening; disposing a container at least partially within the housing, the container having an exterior surface and containing a medicament; disposing an actuation mechanism at least partially within the housing, the actuation mechanism adapted to exert a force to expel the medication from the container; and at least partially disposing a needle assembly within the housing, the needle assembly having a needle and / or cannula for delivering the medicament; thermally coupling a temperature indicator to the exterior surface of the container, the temperature indicator responding to changes in temperature of the container; A method comprising:

12. 12. The method of claim 11, wherein the step of providing the temperature indicator comprises providing a reversible thermochromic sensor having a first operating temperature range.

13. 13. The method of claim 11 or 12, further comprising at least partially covering the at least one opening with a window.

14. The method of claim 13 , wherein the window comprises a magnifying glass window.

15. 15. The method of claim 13 or 14, wherein the window is coupled to the temperature display.

16. 16. The method of any one of claims 11 to 15, further comprising disposing an insulating member around an outer side wall of the temperature display such that the insulating member thermally insulates the temperature display from the housing.

17. The method according to any one of claims 11 to 16, wherein the temperature indicator is made from a material with high thermal conductivity.

18. A method according to any one of claims 11 to 17, wherein the temperature indicator is in the form of a label at least partially surrounding the exterior surface of the container.

19. 19. The method of any one of claims 11 to 18, further comprising operatively coupling a plurality of temperature indicators to the exterior surface of the container, each of the plurality of temperature indicators having a different operating temperature range.

20. The method of any one of claims 11 to 19, further comprising disposing a thermally conductive material between the container and the temperature indicator.

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