Packaging systems for medical devices

Abstract

Packaging systems for medical devices such as drug delivery devices are disclosed. The packaging system may include a carton and a tray disposed or configured to be disposed at least partially in the carton. The tray may include a cavity configured to receive at least a portion of the drug delivery device or other medical device. All of or substantially all of the carton and / or the tray may be recyclable, biobased, biodegradable, and / or paper-based.

Description

PACKAGING SYSTEMS FOR MEDICAL DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] Priority is claimed to United States Provisional Patent Application No. 63 / 585,573, filed September 26, 2023, the entire contents of which are hereby incorporated by reference herein.FIELD OF DISCLOSURE

[0002] The present disclosure generally relates to packaging systems for the storage, transport, and marketing of medical devices. More particularly, the present application relates to packaging systems for drug delivery devices including, for example, autoinjectors.BACKGROUND

[0003] Drug delivery devices and other medical devices often come in specialized packaging which a user or other individual must remove prior to use of the device. Such devices typically must adhere to regulatory standards pertaining to, for example, sterility, labeling, and usability. The packaging may contribute to meeting these standards and therefore facilitate safe and effective use of the device. For instance, the packaging may be designed to protect the medical device from external hazards during distribution and storage. The packaging may also be used to provide or contain informational materials to assist a user in, for example, identifying and operating the medical device.

[0004] Typically, a user will discard or dispose of the packaging after removing the medical device, which creates waste. The environmental impact of this waste is of growing concern as medical devices become more prevalent. Moreover, many existing packaging systems for medical devices are made of materials which are not recyclable, including, for example, certain plastics.

[0005] To address one or one of the needs and challenges mentioned herein and other related needs and challenges, the present disclosure set forth advantageous packaging systems for drug delivery devices and other medical devices.SUMMARY

[0006] One aspect of the present disclosure provides a packaging system for one or more medical devices such as one or more drug delivery devices. The packaging system may include a carton and a tray disposed or configured to be disposed at least partially in the carton. The tray may include a cavity configured to receive at least a portion of the drug delivery device or other medical device. All of or substantially all of the carton and / or the tray may be recyclable, biobased, biodegradable, and / or paper-based.

[0007] Another aspect of the present disclosure provides a packaging system for one or more medical devices such as one or more drug delivery devices, wherein the packaging system includes a paper-based tray. The paper-based tray may include a cavity configured to receive at least a portion of the drug delivery device. The cavity may include a first portion having a first width and configured to receive a distal end of the drug delivery device. The cavity may further include a second portion having a second width and configured to receive a proximal end of the drug delivery device. The cavity may additionally include a third portion having a third width and disposed between the first portion of the cavity and the second portion of the cavity. The third width of the third portion of the cavity may be larger than the first width of the first portion of the cavity and / or the second width of the second portion of the cavity.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily drawn to scale.

[0009] Fig. 1 is a is a perspective view of a packaging system in a partially disassembled state in accordance with various embodiments.

[0010] Fig. 2 is top perspective view of the tray and drug delivery device of the packaging system in Fig. 1.

[0011] Fig. 3 is an enlarged view of a proximal or rear portion of Fig. 2, with the tray being depicted in a cross-sectional view taken along a longitudinal axis A and the drug delivery device being shown in a perspective view.

[0012] Fig. 4 is a perspective view of the tray in Fig. 1.

[0013] Fig. 5 is a top plan view of the top end of the tray in Fig. 1.

[0014] Fig. 6 is a side plan view of the front end of the tray in Fig. 1.

[0015] Fig. 7 is a side plan view of a lateral side of the tray in Fig. 1.

[0016] Fig. 8 is perspective view of another embodiment of a tray in accordance with the present disclosure.

[0017] Fig. 9 is a top plan view of the top end of the tray in Fig. 8.

[0018] Fig. 10 is a side plan view of the front end of the tray in Fig. 8.

[0019] Fig. 11 is a side plan view of a lateral side of the tray in Fig. 8.DETAILED DESCRIPTION

[0020] The present disclosure generally pertains to packaging systems for drug delivery devices such as autoinjectors and other medical devices. The packaging systems disclosed herein are designed and configured to limit their environmental impact and provide other benefits and advantages. In some embodiments, the packaging systems may be constructed in whole or in part of one or more recyclable materials, including, for example, one or more biodegradable and / or biobased materials.Employing such materials may improve the environmental compatibility and / or sustainability of the presently disclosed packaging systems, including, for example, by reducing or eliminating the waste generated when the packaging system is discarded postuse. Further described are features for securing the drug delivery device within packaging system and which may facilitate the use of one or more recyclable materials. These and other benefits and advantages will be apparent to one of ordinary skill in the art reviewing the present disclosure.

[0021] Fig. 1 illustrates a packaging system 10 according to an embodiment of the present disclosure. The packaging system 10 may include a carton 11, a tray 12, an information holder 14, and a drug delivery device 16. Fig. 1 depicts the packaging system 10 in a partially disassembled state, with a lid 18 of the carton 11 in an open position and with the information holder 14 having been removed from the carton 11. When the packaging system 10 is in an assembled state, the information holder 14 may be disposed inside of the carton 11 and surround the tray 12, and the lid 18 may be positioned in a closed position covering an opening 20 in the top of the carton 12. In alternative embodiments, the information holder 14 and / or drug delivery device 16 may omitted.

[0022] The drug delivery device 16 illustrated in Fig. 1 is an autoinjector. However, the drug delivery device 16 may take other forms in other embodiments including, for example, a syringe, a pre-filled syringe, a pen injector, an on-body injector, and / or an infusion pump. Generally, the drug delivery device 16 may be configured to automate and / or simplify various aspects of injecting a drug into a patient. The drug may be, but is not limited to, various biologies such as peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, although the present disclosure is not limited to a particular state.

[0023] Various implementations and configurations of the drug delivery device 16 are possible. The present embodiment of the drug delivery device 16 is configured as multiple-use reusable injector. In other embodiments, the drug delivery device 16 may be configured as a single-use, disposable injector. The drug delivery device 16 may be operable for self-administration by a patient or for administration by caregiver or a formally trained healthcare provider (e.g., a doctor or nurse). In some embodiments, the drug delivery device 16 may be held in the hand of a user over the duration of drug delivery.

[0024] The drug delivery device 16 may include a drive configured to provide the force needed to move one or more components of the drug delivery device 16. In some embodiments, the drive may be configured to move a plunger to expel a drug from a container into the patient via a needle or other delivery member. Additionally or alternatively, the drive may be configured to move the needle or other delivery member from an initial position inside of the drug delivery device 16 to anextended position outside of the drug delivery device 16 for insertion into the patient’s skin or other tissue. The drive may be electrical, mechanical, electromechanical, chemical, or any combination thereof. The drive may be configured to store energy, and, upon or in response to activation of the drive by the user, release or output that energy to move the plunger, drug storage container, and / or other component(s) of the drug delivery device 16. For example, the drive may include an electric motor and / or battery configured to store electrical energy. As another example, the drive may include one or more springs (e.g., a helical compression spring, a helical extension spring, a helical torsion spring, a spiral torsion spring, etc.) configured to store mechanical energy.

[0025] The drug delivery device 16 may have a generally elongate shape extending along a longitudinal axis A between a distal end 22 and a proximal end 24. The distal end 22 may be configured to be pressed or held against the patient’s skin at an injection site during drug delivery and include at least one opening configured to permit a needle or other delivery member to extend outside of the drug delivery device 16 for insertion into the patient during drug delivery. The proximal end 24 may be dimensioned and / or shaped to allow a person to grasp the proximal end 24 in a single one of his or her hands during, for example, removal of the drug delivery device 16 from the tray 12 and / or operation of the drug delivery device 16.

[0026] The drug delivery device 16 may include a housing 26 which may define at least a portion of the exterior of the drug delivery device 16 and which may be configured to contain and / or protect various internal components of the drug delivery device 16 including, for example, the drive and a drug storage container. The housing 26 may have a generally elongate shape, such as a generally cylindrical or tubular shape, and may extend along a longitudinal axis A. In the embodiment illustrated in Fig. 1, a diameter or width of a proximal end of the housing 26 is less than a diameter or width of a distal end of the housing 26.Furthermore, the housing 26 includes a tapered portion between the proximal and distal ends of the housing 26 and the tapered portion may have a sloped exterior surface 26a. The sloped exterior surface 26a may be angled, curved, or otherwise nonparallel with respect to the longitudinal axis A, such that a width or diameter of the housing 26 decreases when moving in a direction (e.g., the proximal direction) along the longitudinal axis A away from the distal end 22 toward the proximal end 24 of the drug delivery device 16.

[0027] The housing 26 may be constructed of multiple, separate but interconnected structures, or the housing 26 may be a single, one-piece, unitary structure.

[0028] The drug delivery device 16 may include one or more buttons disposed at an exterior surface of the housing 26. The button(s) may be flush with or protrude from the exterior surface of the housing 26. The button(s) may be configured to allow a user to activate and / or control various aspects of the operation of the drug delivery device 16 including, for example, activating the drive of the drug delivery device 16 to insert a needle into the patient and / or expel a drug from the drug delivery device 16. Fig. 1 illustrates that a button 28 which protrudes generally in proximal direction from the exterior surface of the housing 26 near the proximal end 24 of the drug delivery device 16. In some embodiments, the button 28 may include a generally proximally facing surface 28a which defines the proximal-most portion of the drug delivery device 16. The drug delivery device 16 may further includes buttons 30 and 32 which include respective radially outwardly facing surfaces 30a and 32a with respect to the longitudinal axis A. As seen in Fig. 1, the radially outwardly facing surfaces 30a and 32a of, respectively, the buttons 30 and 32 may be flush or substantially flush with a radially outwardly facing surface of the housing 26. Alternatively, the button 30 and / or button 32 may protrude in the radial direction from the radially outwardly facing surface of the housing 26.

[0029] The drug delivery device 16 may further include a display 34 (e.g., an electronic display, a touchscreen, a mechanical display, etc.) disposed at an exterior surface of the housing 26 for communicating information pertaining to the drug delivery device 16 to the user. As seen in Fig. 1, the display 34 be positioned in a circumferential direction midway or substantially midway between the buttons 30 and 32 and may face generally in the radially outward direction with respect to the longitudinal axis A.

[0030] The housing 26 may contain or be configured to contain a drug storage container. In some embodiments, the drug storage container may be pre-filled and shipped, e.g., by a manufacturer, to a location where the drug storage container is combined, e.g., by a user, with a remainder of the drug delivery device 16. In some embodiments, the drug storage container may be a pre-filled syringe and / or have a staked, hollow metal needle for the delivery member. In some embodiments, the drug storage container may be configured to move with respect to the housing 26 to facilitate insertion of the delivery member into the patient’s skin prior to drug delivery and / or withdrawal of the delivery member from the patient’s skin after drug delivery. In other embodiments, the drug storage container may be fixedly coupled with the housing 26 such that the drug storage container does not move with respect to the housing 26 during operation of the drug delivery device 16. In some embodiments, the drug storage container may include a stopper which is configured to move through a reservoir of the drug storage container (e.g., along and / or parallel to the longitudinal axis A) to move a drug out of the drug storage container and into the patient via the delivery member.

[0031] In some embodiments, a volume of a drug included in the drug storage container may be equal to 1 mL, or equal to approximately (e.g., ±10%) 1 mL, or equal to 2.5 mL, or equal to approximately (e.g., ±10%) 2.5 mL, or equal to 3 mL, or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 1 mL, or less than or equal to approximately (e.g., ±10%) 2 mL, or less than or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 4 mL, or less than approximately (e.g., ±10%) 5 mL, or less than or equal to approximately (e.g.,±10%) 10 mL, or within a range between approximately (e.g., ±10%) 1 - 10 mL, or within a range between approximately (e.g., ±10%) 1 - 5 mL, or within a range between approximately (e.g., ±10%) 1 - 4 mL, or within a range between approximately (e.g., ±10%) 1 - 3 mL, or within a range between approximately (e.g., ±10%) 1 - 2.5 mL.

[0032] The carton 11 may be a box or any other container configured to, for example, protect the drug delivery device 16 and / or other contents of the packaging system 10 from external elements during, for example, transport and / or storage. In some embodiments, the carton 11 may be configured to protect the drug delivery device 16 from heat, light, moisture, vibrations, sudden impacts, tampering, dirt, contaminants, and / or other potential hazards. The carton 11 may include a compartment or cavity 40 configured to receive at least the tray 12 and, if it is included, the information holder 14 surrounding the tray 12. As illustrated in Fig. 1, the cavity 40 may be dimensioned and / or shaped to snugly receive the tray 12, such that the walls of the carton 11 prevent or inhibit the tray 12 from moving within the cavity 40 during transport and / or storage. When the lid 18 is in the closed position, the exterior of the carton 11 may have a generally rectangular box shape or any other suitable shape.

[0033] The carton 11 may include one or more openings which communicate with and / or provide access to the cavity 40. As illustrated in Fig. 1, the top of the carton 11 includes an opening 20 which communicates with and provides access to the cavity 40 when the lid 18 is in the open position. The lid 18 may be disposed across and / or may cover the opening 20 when the lid 18 is in the closed position, thereby preventing or inhibiting access to the cavity 40.

[0034] In some embodiment, including the embodiment illustrated in Fig. 1 , the lid 18 may be an extension of a main body 42 of the carton 11 and may include a fold line 44 which allows a user or other individual to selectively move the lid 18 with respect to the main body 42 between, for example, the closed position and the open position, and vice versa. In some embodiments, the lid 18 may be configured as a folding flap. In other embodiments, the lid 18 may be wall or other part of the carton 11 that is removably attached to the main body 42 of the carton 11, such that uncovering the opening 20 involves removing the lid 18 from the carton 11.

[0035] As shown in Fig. 1, the carton 11 may have a length LC extending generally in a horizontal direction when a bottom of the carton 11 is laid on a horizontal external surface and / or may be parallel or substantially parallel to the longitudinal axis A of the drug delivery device 16. The carton 11 may have a width CW extending generally in a horizontal direction when a bottom of the carton 11 is laid on a horizontal external surface and / or may be perpendicular or substantially perpendicular to the longitudinal axis A of the drug delivery device 16 and / or the length 11 of the carton 11. The carton 11 may have a height CHextending generally in a vertical direction when a bottom of the carton 11 is laid on a horizontal external surface and / or may be perpendicular or substantially perpendicular to the longitudinal axis A of the drug delivery device 16.

[0036] In some embodiments, the length CL of the carton 11 may be within a range between approximately (e.g., ±10%) 200 - 300 mm, or within a range between approximately (e.g., ±10%) 225 - 275 mm, or within a range between approximately (e.g., ±10%) 225 - 250 mm, or equal to approximately (e.g., ±10%) 245 mm. In some embodiments, the width CW of the carton 11 may be within a range between approximately (e.g., ±10%) 50 - 150 mm, or within a range between approximately (e.g., ±10%) 75 - 125 mm, or within a range between approximately (e.g., ±10%) 100 - 120 mm, or equal to approximately (e.g., ±10%) 110 mm. In some embodiments, the height CH of the carton 11 may be within a range between approximately (e.g., ±10) 25 - 75 mm, or within a range between approximately (e.g., ±10%) 35 - 65 mm, or within a range between approximately (e.g., ±10%) 45 - 65 mm, or equal to approximately (e.g., ±10%) 55 mm. The length CL, width CW, and height CH may correspond to, respectively, the maximum or overall length, width, and height of the carton 11.

[0037] In some embodiments, the carton 11 may be constructed, in whole or in part, from a sheet of material such as, for example, a single continuous blank. The blank initially may have a flat or planar shape. During manufacturing, the blank may be shaped via, for example, pressing, stamping, and / or folding, into the desired shape of the carton 11. Additionally or alternatively, molding process(es) may be used to construct the carton 11. In some embodiments, the carton 11 may be constructed of multiple, separate but interconnected pieces of material.

[0038] The information holder 14 may be configured to hold or retain informational materials (not shown in the figures) related to the drug delivery device 16 at a fixed or substantially fixed location within the carton 11 and / or organize these materials within the carton 11. The informational materials may include, for example, printed documents or pamphlets setting forth, for example, instructions for use (IFU), drug information, regulatory information, warranty information, expiration information, labeling, marketing information, and / or branding information. The information holder 14 may have a sleeve like shape (as illustrated in Fig. 1), a pocket shape, or any other suitable shape. The information holder 14 may include a compartment or cavity 46 configured to receive at least the tray 12, in whole or in part, such that the information holder 14 surrounds at least a portion of the tray 12. The cavity 46 may be dimensioned and / or shaped to snugly receive the tray 12 but allow room for the informational materials to be positioned between an inner surface of the information holder 14 and an outer surface of the tray 12. Additionally or alternatively, the informational materials may be disposed at or coupled with (e.g., adhered to) an exterior surface of the information holder 14.

[0039] In some embodiments, the information holder 14 may be constructed, in whole or in part, from a sheet of material such as, for example, a single continuous blank. The blank initially may have a flat or planar shape. During manufacturing, the blank may be shaped via, for example, pressing, stamping, and / or folding, into the desired shape of the information holder 14. Additionally or alternatively, molding process(es) may be used to construct the information holder 14. In some embodiments, the information holder 14 may be constructed of multiple, separate but interconnected pieces of material.

[0040] Generally, the tray 12 may be configured to support the drug delivery device 16 within the carton 11. As an example, the tray 12 may be configured to hold or retain the drug delivery device 16 at a fixed or substantially fixed location within the main body 42 of carton 11 and / or in a fixed or substantially fixed orientation with respect to at least the main body 42 of the carton 11. As a more specific example, the tray 12 may be configured to immobilize or substantially immobilize the drug delivery device 16 with respect to the tray 12 and / or the carton 11. In some embodiments, the tray 12 may be coupled with carton 11, for example, via an adhesive, mating connector member(s), and / or other mechanical connector member(s). In alternative embodiments, the tray 12 and carton 11 may be integrally formed to define a single, one-piece, unitary structure.

[0041] In some embodiments, the tray 12 may be constructed, in whole or in part, from a sheet of material such as, for example, a single continuous blank. The blank initially may have a flat or planar shape. During manufacturing, the blank may be shaped via, for example, pressing, stamping, and / or folding, into the desired shape of the tray 12. Additionally or alternatively,molding process(es) may be used to construct the tray 12. In some embodiments, the tray 12 may be constructed of multiple, separate but interconnected pieces of material.

[0042] The tray 12 may include a compartment or cavity 50 configured to receive at least a portion of or the entirety of the drug delivery device 16. In some embodiments, such as the embodiment in Fig. 1, the cavity 50 generally may be defined by a wall of the tray 12 which is set back with respect to an adjacent portion of the wall so as to generally form a depression, groove, channel, and / or the like. In alternative embodiments, the cavity 50 may be through hole which extends entirely through the tray 12. Further features and functions of the tray 12 are discussed below.

[0043] The packaging system 10 may be constructed, in whole or in part, of one or more recyclable materials. As an example, all of or substantially all of the packaging system 10 may be constructed of one or more recyclable materials. As a more specific example, all of or substantially all of any one of or any combination of the carton 11, tray 12, and information holder 14, and / or other component(s) of the packaging system 10, may be made of one or more recyclable materials. Constructing the packaging system 10 of one or more recyclable materials may improve the environmental compatibility and / or sustainability of the packaging system 10, including, for example, by reducing or eliminating the waste generated when the packaging system 10 is discarded post-use.

[0044] In some embodiments, the recyclable material(s) used to construct the packaging system 10, including any one or combination of the carton 11, tray 12, and information holder 14, and / or other component(s) of the packaging system 10, may be biodegradable and / or biobased. In some embodiments, one or more paper-based materials may be used to construct all of or substantially all of any one or combination of the carton 11, tray 12, and information holder 14, and / or other component(s) of the packaging system 10. Non-limiting examples of such paper-based materials include: molded pulp (e.g., molded fiber), paperboard, cardboard, cardstock, plain paper, and any combination thereof.

[0045] In some embodiments, no portion of the packaging system 10 and / or no portion of any one or combination of the carton 11, tray 12, and information holder 14 made be made of polyethylene (PE) foam, a non-recyclable plastic, or a petroleum-based material.

[0046] In some embodiments, the entirety of the packaging system 100 may be made of material(s) which is / are sustainable, renewable, and / or recyclable. In some embodiments, the entirety of the packaging system 100 can be recycled in a paperboard and / or paper recycling stream.

[0047] In some embodiments, any one of or any combination of the carton 11, tray 12, and information holder 14, and / or other component(s) of the packaging system 10, may be coated, in part or in whole, with a water-based coating and / or may be resistant to water and / or oil. Such coating(s) and / or properties may facilitate the reusability of the packaging system 10, for example, in scenarios where the drug delivery device 16 is reusable and the user may store the drug delivery device 16 in the carton 11 and / or tray 12 in the time between injections or uses.

[0048] Referring to Figs. 2-11, the configuration and manufacture of the tray 12 will now be described in further detail. Figs. 2- 7 illustrate the tray 12 in an assembled state, where the tray 12 is configured to be received in, for example, the carton 11. Figs. 8-11 illustrate the tray 12 in a pre-assembled state, where the tray 12 is configured for stacking with other trays 12 and / or other component(s), for example, prior to a time when the tray 12 is combined or assembled with the carton 11 to achieve the configuration shown in Fig. 1.

[0049] The tray 12 may generally include a top end 52, a bottom end 54, a forward or front end 56, a rear end 58, a first lateral side 60, a second lateral side 62, and / or other portions. The top end 52 may face generally in an upward vertical direction when the bottom end 54 is laid against a horizontal external surface. When the drug delivery device 16 is received in the tray 12, the distal end 22 of the drug delivery device 16 may be disposed near the front end 56 of the tray 12 and the proximal end 24 of the drug delivery device 16 may be disposed near the rear end 58 of the tray 12.

[0050] In the assembled state, the tray 12 may have a length TL, a width TW, and a height TH, as seen in Figs. 2 and 5-7. The length TL may extend generally in a horizontal direction when the bottom end 54 of the tray 12 is laid on a horizontal external surface and / or may be parallel or substantially parallel to the longitudinal axis A of the drug delivery device 16. The tray 12 may have a width TW extending generally in a horizontal direction when the bottom end 54 of the tray 12 is laid on a horizontal external surface and / or may be perpendicular or substantially perpendicular to the longitudinal axis A of the drug delivery device 16 and / or the length TL of the tray 12. The tray 12 may have a height TH extending generally in a vertical direction when the bottom end 54 of the tray 12 is laid on a horizontal external surface and / or may be perpendicular or substantially perpendicular to the longitudinal axis A of the drug delivery device 16. In some embodiment, the length TL, width TW, and height TH of the tray 12 may correspond to, respectively, the maximum or overall length, width, and height of the tray 12.

[0051] In some embodiments, the length TL of the tray 12 in the assembled state may be within a range between approximately (e.g., ±10%) 200 - 300 mm, or within a range between approximately (e.g., ±10%) 225 - 275 mm, or within a range between approximately (e.g., ±10%) 225 - 250 mm, or equal to approximately (e.g., ±10%) 241 mm, or equal to 241.3 mm ± 0.5 mm, or less than approximately (e.g., ±10%) 500 mm, or less than approximately (e.g., ±10%) 400 mm, or less than approximately (e.g., ±10%) 300 mm, or less than approximately (e.g., ±10%) 250 mm. In some embodiments, the width TW of the tray 12 may be within a range between approximately (e.g., ±10%) 50 - 150 mm, or within a range between approximately (e.g., ±10%) 75 - 125 mm, or within a range between approximately (e.g., ±10%) 100 - 115 mm, or equal to approximately (e.g., ±10%) 105 mm, or equal to 104.8 mm ± 0.5 mm, or less than approximately (e.g., ±10%) 150 mm, or less than approximately (e.g., ±10%) 125 mm, or less than approximately (e.g., ±10%) 115 mm, or less than approximately (e.g., ±10%) 110 mm. In some embodiments, the height TH of the tray 12 may be within a range between approximately (e.g., ±10) 25 - 75 mm, or within a range between approximately (e.g., ±10%) 35 - 65 mm, or within a range between approximately (e.g., ±10%) 45 - 65 mm, or equal to approximately (e.g., ±10%) 51 mm, or equal to 50.8 mm ± 0.5 mm, or less than approximately (e.g., ±10%) 75 mm, or less than approximately (e.g., ±10%) 65 mm, or less than approximately (e.g., ±10%) 60 mm, or less than approximately (e.g., ±10%) 55 mm.

[0052] In some embodiments, a sheet of material and / or other element(s) used to construct the tray 12 may have a thickness T1. In some embodiments, the thickness T1 may be constant or substantially constant over all of or substantially all of the tray 12. In some embodiments, the thickness T1 may be within a range between approximately (e.g., ±10%) 0.5 - 3 mm, or within a range between approximately (e.g., ±10%) 0.5 - 2 mm, or within a range between approximately (e.g., ±10%) 0.5 - 1.5 mm, or within a range between approximately (e.g., ±10%) 0.75 - 1.25 mm, or equal to approximately (e.g., ±10%) 1 mm, or equal to 1.0 mm ± 0.15 mm, or less than approximately (e.g., ±10%) 3 mm, or less than approximately (e.g., ±10%) 2 mm, or less than approximately (e.g., ±10%) 1.5 mm, or less than approximately (e.g., ±10%) 1.25 mm. In alternative embodiments, the thickness T 1 may vary across the tray 12.

[0053] As illustrated in Fig. 4, the bottom of the cavity 50 may be closed off by a wall at least partially defining the bottom end 54 of the tray 12, whereas the top of the cavity 50 may be open such that the drug delivery device 16 can be inserted into and / or removed from the tray 12.

[0054] The cavity 50 of the tray 12 may have a first portion 50a having width TC1, a second portion 50b having a width TC2, a third portion 50c having a width TC3, a fourth portion 50d having a width TC4, a fifth portion 50e having a width TC5, and / or other portion(s) having other width(s). The widths TC1-TC5 each may extend generally in a horizontal direction when the bottom end 54 of the tray 12 is laid on a horizontal external surface and / or may be perpendicular or substantially perpendicular to the longitudinal axis A of the drug delivery device 16 and / or the length TL of the tray 12. Any one or combination of the widths TC1- TC5 may be constant or substantially constant, or may vary, when moving along the longitudinal axis A.

[0055] In some embodiments, the width TC1 of the first portion 50a of the cavity 50 may be larger than or equal to the width TC2 of the second portion 50a of the cavity 50. In some embodiments, the width TC3 of the third portion 50c of the cavity 50may be larger than the width TC1 of the first portion 50a of the cavity, the width TC2 of the second portion 50b of the cavity 50, the width TC4 of the fourth portion 50d of the cavity 50, and / or the width TC5 of the fifth portion 50e of the cavity 50. In some embodiments, the width TC4 of the fourth portion 50d of the cavity 50 may be larger than the width TC1 of the first portion 50a of the cavity 50, the width TC2 of the second portion 50b of the cavity 50, and / or the width TC5 of the first portion 50e of the cavity 50 but smaller than the width TC3 of the third portion 50c of the cavity 50.

[0056] As seen in Fig. 5, the width TC5 of the fifth portion 50e of the cavity 50 may decrease (continuously or intermittently) when moving in a direction (e.g., the proximal direction) away from the first portion 50a and / or fourth portion 50d of the cavity 50 toward the third portion 50c and / or second portion 50b of the cavity 50. As a result, the fifth portion 50e of the cavity 50 may have a tapered appearance when viewed from above, as seen in Fig. 5. In some embodiments, the width TC5 of the fifth portion 50e of the cavity 50 may be: (i) equal to or smaller than the width TC1 of the first portion 50a and / or the fourth portion 50d of the cavity 50; and / or (ii) equal to or larger than the width TC2 of the second portion 50b of the cavity 50.

[0057] As illustrated in Figs. 1 and 2, the first portion 50a of the cavity 50 may be configured (e.g., via its dimensioning and / or shape) to receive, in whole or in part, the distal end 22 of the drug delivery device 16. The second portion 50b of the cavity 50 may be configured (e.g., via its dimensioning and / or shape) to receive, in whole or in part, the proximal end 24 of the drug delivery device 16. The third portion 50c of the cavity 50 may be disposed between the first portion 50a and the second portion 50b and may be configured (e.g., via its dimensioning and / or shape) to receive, in whole or in part, at least a portion of the drug delivery device 16, including, for example, a portion of the drug delivery device 16 which has a width that is less than that of the distal end 22 of the drug delivery device 16.

[0058] The third portion 50c of the cavity 50 may be configured (e.g., via its dimensioning and / or shape) to allow a person to grasp the proximal end 24 of the drug delivery device 16 in at least a single one of his or her hands and pull upwardly on the drug delivery device 16 to remove the drug delivery deice 16 from the tray 12. As an example, the width TC3 of the third portion 50c of the cavity 50 may be selected to allow a person position one or more of their fingers on one lateral side of the drug delivery device 16 and to position their thumb on an opposite lateral side of the drug delivery device 16 to grasp and then pull on the drug delivery device 16 to remove it from the tray 12. As a more specific example, the width TC3 of the third portion 50c of the cavity 50 may be within a range between approximately (e.g., ±10%) 50 - 150 mm, or within a range between approximately (e.g., ±10%) 75 - 125 mm, or within a range between approximately (e.g., ±10%) 100 - 115 mm.

[0059] The third portion 50c of the cavity 50 may have a length TCL which is the same or substantially the same in the assembled and pre-assembled states of the tray 12. The length TCL may extend generally in a horizontal direction when the bottom end 54 of the tray 12 is laid on a horizontal external surface and / or may be parallel or substantially parallel to the longitudinal axis A of the drug delivery device 16. In some embodiments, the length TCL may be within a range between approximately (e.g., ±10%) 40 - 80 mm, or within a range between approximately (e.g., ±10%) 50 - 70 mm, or within a range between approximately (e.g., ±10%) 55 - 65 mm, or equal to 60 mm ± 0.5 mm, or less than approximately (e.g., ±10%) 80 mm, or less than approximately (e.g., ±10%) 70 mm, or less than approximately (e.g., ±10%) 65 mm. The length TCL may vary across the width TC3 of the third portion 50c of the cavity 50 or may be constant or substantially constant across the width TC3 of the third portion 50c of the cavity 50.

[0060] In some embodiments, to facilitate a person’s grasp of the proximal end 24 of the drug delivery device 16 when removing the drug delivery device 16 from the tray 12, the cavity 50 of the tray 12 may include a sixth portion 50f which is positioned vertically below the third portion 50c of the cavity 50 and vertically below the proximal end 24 of the drug delivery device 16 (when in the tray 12), as seen in Figs. 4 and 5. The sixth portion 50f of the cavity 50 may allow a person to slip his or her fingers and / or thumb beneath the proximal end 24 of the drug delivery device 16, thereby potentially improve their grasp of the proximal end 24 of the drug delivery device 16 when removing the drug delivery device 16 form the tray 12.

[0061] The fourth portion 50d of the cavity 50 may be configured (e.g., via its dimensioning and / or shape) to receive the portion of the drug delivery device 16 including the button 30, button 32, and / or other manually operable and / or functional feature(s) disposed at the exterior of the housing 26 of the drug delivery device 16. The width TC4 of the fourth portion 50d of the cavity 50 may be selected so as to reduce or eliminate the possibility of an inner surfaces of the tray 12 pressing against and / or inadvertently operating the button 30, button 32, and / or other manually operable and / or functional feature(s) disposed at the exterior of the housing 26 of the drug delivery device 16. In some embodiments, inner surfaces 68 and 70 of the tray 12 which at least partially define the fourth portion 50d of the cavity 50 may each be spaced by a buffer distance or gap from, respectively, the radially outwardly facing surface 30a of the button 30 of the drug delivery device 16 and the radially outwardly facing surface 32a of the button 32 of the drug delivery device 16. This buffer distance or gap may be measured in a radial and / or perpendicular direction with respect to the longitudinal axis A of the drug delivery device 16. In some embodiments, the fourth portion 50d of the cavity 50 may be disposed between the first portion 50a of the cavity 50 and the fifth portion 50e of the cavity 50, as seen in Fig. 5.

[0062] The fifth portion 50e of the cavity 50 may be configured (e.g., via its dimensioning and / or shape) to receive a tapered portion of the drug delivery device 16 including, for example, the portion of the housing 26 of the drug delivery device 16 having the sloped exterior surface 26a. In some embodiments, the width TC5 of the fifth portion 50e of the cavity 50 may vary so as to complement (e.g., conform to) the sloped exterior surface 26a when the drug delivery device 16 is received in the cavity 50 of the tray 12. In some embodiments, inner surface surfaces 64 and 66 of the tray 12, which at least partially define the fifth portion 50e of the cavity 50, may contact or be positioned immediately adjacent to the sloped exterior surface 26a of the housing 26 of the drug delivery device 16 so as to prevent or inhibit the drug delivery device 16 from moving in the proximal and / or distal directions along the longitudinal axis A and / or in a radial direction with respect to the longitudinal axis A, for example, as a result of a sudden impact event resulting from, for example, the packaging system 10 striking the ground after being accidentally dropped from a height. In some embodiments, the inner surface surfaces 64 and 66 of the tray 12 of the tray 12 may squeeze or otherwise grip the sloped exterior surface 26a of the housing 26 of the drug delivery device 16, for example, to inhibit or prevent movement of the drug delivery device 16 with respect to the tray 12 during transport and / or storage. Furthermore, in some embodiments, the inner surfaces 64 and 66 of the tray 12 each may be angled, curved, or otherwise non-parallel with respect to the longitudinal axis A of the drug delivery device 16 (when it is received in the cavity 50 of the tray 12), and the angling and / or curvature of each of the inner surfaces 64 and 66 of the tray 12 may be the same as or substantially the same as that of the sloped exterior surface 26 of the drug delivery device 16.

[0063] In some embodiments, the tray 12 may be configured to retain the drug delivery device 16 in a position such that a buffer distance or gap Z (see Fig. 3) exists between a distally or forwardly facing inner surface 72 of the tray 12 and a proximally or rearwardly facing outer surface of the proximal end 24 of the drug delivery device 16 including, for example, the proximally facing surface 28a of the button 28 of the drug delivery device 16. The buffer distance or gap Z may be measured in direction that is parallel or substantially parallel to the longitudinal axis A. The buffer distance or gap Z may reduce or eliminate the possibility that, in the event of, for example, a sudden impact event causes the drug delivery device 16 to move in the proximal or rearward direction with respect to the tray 12, the distally or forwardly facing inner surface 72 of the tray 12 comes into contact with and potentially presses the button 28, which could result in premature activation of the drug delivery device 16.

[0064] In some embodiments, the buffer distance or gap Z may be achieved by configuring the tray 12 such that a length CL (corresponding, in some embodiments, to an overall or maximum length of the cavity 50) between the distally or forwardly facing inner surface 72 of the tray 12 and a proximally or rearwardly facing inner surface 74 of the tray 12 is larger than a maximum or overall axial length of the drug delivery device 16. The length CL may extend generally in a horizontal direction when the bottom end 54 of the tray 12 is laid on a horizontal external surface and / or may be parallel or substantially parallel to the longitudinal axis A of the drug delivery device 16.

[0065] In some embodiments, an upwardly facing inner surface 76 of the bottom end 54 of tray 12 may be dimensioned and / or shaped to complement (e.g., conform to) at least a portion of the exterior surface of the housing 26 of the drug delivery device 16. This may help support and / or retain the drug delivery device 16 in the tray 16. As seen in Fig. 3, the upwardly facing inner surface 76 of the bottom end 54 of tray 12 may define at least partially the second portion 50b of the cavity 50 and may contact the exterior surface of the housing 26 of the drug delivery device 16. Furthermore, in some embodiments, the upwardly facing inner surface 76 of the tray 12 may be angled, curved, or otherwise non-parallel with respect to the longitudinal axis A of the drug delivery device 16 (when it is received in the cavity 50 of the tray 12), and the angling and / or curvature of the upwardly facing inner surface 76 of the tray 12 may be the same as or substantially the same as that of the contacting portion of the exterior surface of the housing 26 of the drug delivery device 16.

[0066] The front end 56 of the tray 12 and / or rear end 58 of the tray 12 may include feature(s) which facilitate stacking of the tray 12 in the pre-assembled state (Figs. 8-11) and / or provide support to wall(s) of the tray 12 defining the cavity 50 in the assembled state (Figs. 1-7). As an example, the front end 56 of the tray 12 may have a generally horizontal, unfolded configuration in the pre-assembled state and a generally vertically, folded configuration in the assembled state. Similarly, the rear end 58 of the tray 12 may have a generally horizontal, unfolded configuration in the pre-assembled state and a generally vertically, folded configuration in the assembled state. When in their respective folded configurations, the front end 56 of the tray 12 may include a fold line 56a that is distal to or forward of the cavity 50 and the rear end 58 of the tray 12 may include a fold line 58a that is proximal to or rearward of the cavity 50, as seen in Fig. 4.

[0067] As a result of folding the front end 56 at the fold line 56a and / or folding the rear end 58 at the fold line 58a, the length TL of the tray 12 may decrease but the height TH and width TW of the tray 12 may remain the same or substantially the same. In some embodiments, the length TL of the tray 12 in the pre-assembled state may be within a range between approximately (e.g., ±10%) 300 - 400 mm, or within a range between approximately (e.g., ±10%) 325 - 375 mm, or within a range between approximately (e.g., ±10%) 330 - 340 mm, or equal to approximately (e.g., ±10%) 339 mm,

[0068] or equal to 338.9 mm ± 0.5 mm, or less than approximately (e.g., ±10%) 500 mm, or less than approximately (e.g., ±10%) 400 mm, or less than approximately (e.g., ±10%) 300 mm, or less than approximately (e.g., ±10%) 350 mm.

[0069] The front end 56 of the tray 12 may include a support member 56b which: extends generally downwardly toward the bottom end 54 of tray 12 in the pre-assembled state; and extends generally horizontally toward the cavity 50 and / or the rear end 58 of the tray 12 in the assembled state. In the illustrated embodiment, the support member 56b corresponds to an outer surface of a wall of the tray 12 having an inner surface at least partially defining a depression formed in the front end 56 of the tray 12. In the assembled state, the support member 56b may contact or be configured to contact (e.g., by being positioned immediately adjacent to) an outer surface of a wall of the tray 12 having an inner surface at least partially defining the first portion 50a of the cavity 50. Accordingly, in the assembled state, the support member 56b may provide support to the wall of the tray 12 at least partially defining the first portion 50a of the cavity 50 and / or provide a shock absorbing effect reducing the likelihood that this wall is deformed as a result of, for example, a sudden impact occurring during transport and / or storage due. In the pre-assembled state, to facilitate stacking of the tray 12, the support member 56b may be temporarily received in the depression defining a similar support member of another tray. Accordingly, the support member 56b may reduce the overall height of a stack of trays waiting to be assembled.

[0070] Additionally, or alternatively, the rear end 58 of the tray 12 may include a support member 58b which: extends generally downwardly toward the bottom end 54 of tray 12 in the pre-assembled state; and extends generally horizontally toward the cavity 50 and / or the front end 56 of the tray 12 in the assembled state. In the illustrated embodiment, the support member 58b corresponds to an outer surface of a wall of the tray 12 having an inner surface at least partially defining a depression formed in the rear end 58 of the tray 12. In the assembled state, the support member 58b may contact or be configured to contact (e.g., by being positioned immediately adjacent to) an outer surface of a wall having an inner surface at least partially defining the secondportion 50b of the cavity 50. Accordingly, in the assembled state, the support member 58b may provide support to the wall of the tray 12 at least partially defining the second portion 50b of the cavity 50 and / or provide a shock absorbing effect reducing the likelihood that this wall is deformed as a result of, for example, a sudden impact occurring during transport and / or storage due. In the pre-assembled state, to facilitate stacking of the tray 12, the support member 58b may be temporarily received in the depression defining a similar support member of another tray. Accordingly, the support member 58b may reduce the overall height of a stack of trays waiting to be assembled.

[0071] In some embodiments, the bottom end 54 of the tray 12 may include one or more label support surfaces configured to allow one to adhere or otherwise couple an informational label to the tray 12. As an example, as seen in Figs. 7 and 10, a wall of the tray 12 having an inner surface at least partially defining the first portion 50a of the cavity 50 may include a protrusion 80 which generally extends horizontally away from the first portion 50a of the cavity 50. The protrusion 80 may be generally rectangularly shaped, or any other suitable shape. Furthermore, the protrusion 80 may have a generally planar outwardly facing surface 80a to which an informational label may be adhered.

[0072] All features described herein, including in the specification, claims, abstract, and drawings, and all the steps in any method or process described herein, may be combined in any combination, except combinations where one or more of the features and / or steps are mutually exclusive.

[0073] As will be recognized, the systems and methods according to the present disclosure may have one or more advantages relative to conventional technology, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well.

[0074] The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologies, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also encompassed. The drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.

[0075] The drug will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.

[0076] In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim , 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).

[0077] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa),Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK- 2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

[0078] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to the receptor; Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as 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, a dimer of a human-mouse monoclonal h LL2 gamma-chain disulfide linked to a human-mouse monoclonal h LL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti- IGF-1 R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1” and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal lgG2 antibodies, including but not limited to fully human lgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that 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, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, 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, and the like, and other TALL specific binding proteins; Parathyroid hormone (“PTH”) specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, related proteins, and the like;Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the 0X40 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® (epoetin alfa, or erythropoietin); GLP- 1, Avonex® (interferon beta-1 a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta);Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti- a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TN F-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-HER2monoclonal antibody, biosimilar to Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancers; Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Immunoglobulin G2 Human Monoclonal Antibody to 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® (methoxy polyethylene glycol- epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, GDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1 A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); 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-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb / llia receptor monoclonal antibody); Actemra® (anti-l L6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); MvasiTM (bevacizumab- awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human IgG 1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to IgG 1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-l L-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); ONTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti- TRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5pi integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti- C. difficile Toxin A and Toxin B C 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 Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; antiganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNa mAb (MEDI-545, MDX-198); anti-IGF1 R mAb; anti-IGF-1 R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-l L12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-l L2Ra mAb (HuMax-TAC); anti-l L5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); BMS-66513; anti-Mannose Receptor / hCGp mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); anti-TGFB 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).

[0079] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for treatment of postmenopausal osteoporosis and / or fracture healing and in other embodiments, a monoclonal antibody (IgG) that binds 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 with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with orthe device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV / CD; OrienXOW; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used 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 for 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 with a drug delivery device of the present disclosure. Additionally, bispecific T cell engager (BITE®) molecules such as but not limited to BLINCYTO® (blinatumomab) can 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 analogues thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or 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 AvsolaTM (infliximab-axxq), anti- TNF a monoclonal antibody, biosimilar to 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 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 with Otezla® (apremilast), N-[2-[(1 S)-1 -(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1 ,3-dioxo- 1 H-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 with ParsabivTM (etelcalcetide HCI, KAI-4169) or another product containing etelcalcetide HCI 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 with ABP 798 (rituximab), a biosimilar candidate to Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used 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 Fc domain of IgG 1 ). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate to Soliris®, or another product containing a monoclonal antibody that specifically binds to the complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570) is a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with Omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile mechanisms of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with Sotorasib (formerly known as AMG 510), 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 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 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 with ABP 654 (human I gG 1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human I gG 1kappa antibody and / or binds to the p40 subunit of human cytokines interleukin (I L)- 12 and IL-23. In some embodiments, the drug delivery device may contain or be used with AmjevitaTM or AmgevitaTM (formerly ABP 501) (mab anti-TNF human IgG 1 ), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human lgG1. 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 AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1 R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a Growth Differential Factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing 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 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 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 multi-specific FAP x 4-1 BB-targeting DARPin® biologic under investigation 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 is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin alfa (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 CD3 x epidermal growth factor receptor vl 11 (EGFRvlll) 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-CD33 x anti- 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 protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0080] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments could be implemented,using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention(s) disclosed herein.

[0081] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

What is claimed is:

1. A packaging system for a drug delivery device, the packaging system comprising: a carton; a tray disposed or configured to be disposed at least partially in the carton, wherein the tray comprises a cavity configured to receive at least a portion of the drug delivery device; and wherein all of or substantially all of the carton and the tray is recyclable.

2. The packaging system of claim 1 , wherein all of or substantially all of the carton and / or the tray is biobased and / or biodegradable.

3. The packaging system of any one of claims 1 or 2, wherein all of or substantially all of the carton and / or tray is made of at least one paper-based material.

4. The packaging system of claim 3, wherein the at least one paper-based material comprises molded pulp.

5. The packaging system of any one of claims 1 to 4, comprising an information holder disposed or configured to be disposed at least partially in the carton, wherein all of or substantially all of the information holder is recyclable.

6. The packaging system of claim 5, wherein all of or substantially all of the information holder is made of at least one paper-based material.

7. The packaging system of claim 6, wherein the at least one paper-based material comprises molded pulp.

8. The packaging system of any one of claims 5 to 7, wherein the information holder comprises a sleeve and the tray is disposed or configured to be disposed at least partially in the sleeve.

9. The packaging system of any one of claims 1 to 8, wherein the tray comprises a sheet having been shaped to form at least the cavity.

10. The packaging system of claim 9, wherein the thickness of the sheet is less than 2 mm.

11. The packaging system of any one of claims 9 or 10, wherein the sheet has been shaped to form the cavity by at least one of pressing, stamping, folding, and molding.

12. The packaging system of any one of claims 9 to 11, wherein the sheet is made entirely of a single continuous blank of material.

13. The packaging system of any one of claims 9 to 12, wherein the tray is made entirely of the sheet.

14. The packaging system of any one of claims 1 to 13, wherein the carton comprises an opening and a lid configured to selectively cover the opening.

15. The packaging system of any one of claims 1 to 14, wherein the tray is not made of plastic.

16. The packaging system of any one of claims 1 to 15, wherein the tray is not made of a polyethylene (PE) foam.

17. The packaging system of any one of claims 1 to 16, wherein an entirety of the packaging system is recyclable.

18. The packaging system of any one of claims 1 to 17, wherein the cavity of the tray comprises: a first portion having a first width and configured to receive a distal end of the drug delivery device, a second portion having a second width and configured to receive a proximal end of the drug delivery device, and a third portion having a third width and disposed between the first portion of the cavity and the second portion of the cavity, wherein the third width of the third portion of the cavity is larger than the first width of the first portion of the cavity and / or the second width of the second portion of the cavity.

19. The packaging system of claim 18, wherein the cavity comprises a fourth portion having a fourth width and configured to receive a portion of the drug delivery device having one or more buttons, wherein the fourth width of the fourth portion is larger than the first width of the first portion.

20. The packaging system of any one of claims 18 or 19, wherein the cavity comprises a fifth portion having a fifth width and disposed between the first portion of the cavity and the third portion of the cavity, the fifth width of the fifth portion of the cavity being smaller than or equal to the first width of the first portion of the cavity and / or larger than or equal to the second width of the second portion of the cavity.

21. The packaging system of claim 20, wherein the fifth width of the cavity decreases when moving in a direction away from the first portion of the cavity toward the third portion of the cavity such that the fifth portion of the cavity.

22. The packaging system of any one of claims 18 to 21, wherein the tray comprises: a proximally facing surface at least partially defining the first portion of the cavity; a distally facing surface at least partially defining the second portion of the cavity; and wherein a distance between the proximally facing surface of the tray and the distally facing surface of the tray is larger than a maximum length of the drug delivery device to be received in the tray.

23. The packaging system of claim 22, wherein the tray is configured to support the drug delivery device in a position such that a gap exists between the distally facing surface of the tray and the proximal end of the drug delivery device.

24. The packaging system of any one of claims 18 to 23, wherein the tray comprises an upwardly facing surface at least partially defining the second portion of the cavity, wherein at least a portion of the upwardly facing surface has a curvature which complements a curvature of at least a portion of an exterior surface of the proximal end of the drug delivery device.

25. The packaging system of any one of claims 1 to 24, comprising the drug delivery device, wherein the at least a portion of the drug delivery device is disposed in the tray.

26. The packaging system of claim 25, wherein the drug delivery device is an autoinjector.

27. A packaging system for a drug delivery device, the packaging system comprising: a paper-based tray comprising a cavity configured to receive at least a portion of the drug delivery device, wherein cavity comprises: a first portion having a first width and configured to receive a distal end of the drug delivery device, a second portion having a second width and configured to receive a proximal end of the drug delivery device, and a third portion having a third width and disposed between the first portion of the cavity and the second portion of the cavity, wherein the third width of the third portion of the cavity is larger than the first width of the first portion of the cavity and / or the second width of the second portion of the cavity.

28. The packaging system of claim 27, wherein the first width of the first portion of the cavity, the second width of the second portion of the cavity, and the third width of the third portion of the cavity each extends in a direction that is perpendicular or substantially perpendicular to a longitudinal axis of the drug delivery device when the drug delivery device is received in the cavity of the paper-based tray.

29. The packaging system of claims 27 or 28, wherein the paper-based tray comprises a sheet having been shaped to form at least the cavity.

30. The packaging system of claim 29, wherein the sheet has a constant or substantially constant thickness.

31. The packaging system of claim 30, wherein the thickness of the sheet is less than 2 mm.

32. The packaging system of any one of claims 29 to 31, wherein the sheet has been shaped to form the cavity by at least one of pressing, stamping, folding, and molding.

33. The packaging system of any one of claims 29 to 32, wherein the sheet is made entirely of a single continuous blank of material.

34. The packaging system of any one of claims 29 to 33, wherein the paper-based tray is made entirely of the sheet.

35. The packaging system of any one of claims 27 to 34, comprising a carton, wherein the paper-based tray is disposed at least partially in the carton.

36. The packaging system of claim 35, wherein the carton comprises an opening and a lid configured to selectively cover the opening.

37. The packaging system of any one of claims 27 to 36, wherein the cavity comprises a fourth portion having a fourth width and configured to receive a portion of the drug delivery device having one or more buttons, wherein the fourth width of the fourth portion of the cavity is larger than the first width of the first portion of the cavity.

38. The packaging system of any one of claims 27 to 37, wherein the cavity comprises a fifth portion having a fifth width and disposed between the first portion of the cavity and the third portion of the cavity, the fifth width of the fifth portion of the cavity being smaller than or equal to the first width of the first portion of the cavity and / or larger than or equal to the second width of the second portion of the cavity.

39. The packaging system of claim 38, wherein the fifth width decreases when moving in a direction away from the first portion of the cavity toward the second portion of the cavity such that the fifth portion of the cavity complements a sloped exterior surface of the drug delivery device when the drug delivery device is received in the cavity.

40. The packaging system of any one of claims 27 to 39, wherein the paper-based tray comprises: a proximally facing surface at least partially defining the first portion of the cavity; a distally facing surface at least partially defining the second portion of the cavity; and wherein a distance between the proximally facing surface of the paper-based tray and the distally facing surface of the paper-based tray is larger than a maximum length of the drug delivery device to be received in the paper-based tray.

41. The packaging system of claim 40, wherein the paper-based tray is configured to support the drug delivery device in a position such that a gap exists between the distally facing surface of the paper-based tray and the proximal end of the drug delivery device.

42. The packaging system of any one of claims 27 to 41 , wherein the paper-based tray comprises an upwardly facing surface at least partially defining the second portion of the cavity, wherein at least a portion of the upwardly facing surface has a curvature which complements a curvature of at least a portion of an exterior surface of the proximal end of the drug delivery device.

43. The packaging system of any one of claims 27 to 42, wherein the paper-based tray comprises a first end adjacent to the first portion of the cavity, wherein the first end is folded downwardly and comprises a first support member extending toward the first portion of the cavity.

44. The packaging system of claim 43, wherein the tray comprises a first wall having a first inner surface at least partially defining the first portion of the cavity, and wherein the first support member contacts or is configured to contact a first outer surface of the first wall.

45. The packaging system of any one of claims 27 to 44, wherein the paper-based tray comprises a second end adjacent to the second portion of the cavity, wherein the second end is folded downwardly and comprises a second support member extending toward the second portion of the cavity.

46. The packaging system of claim 45, wherein the tray comprises a second wall having an inner surface at least partially defining the second portion of the cavity, and wherein the second support member contacts or is configured to contact a second outer surface of the second wall.

47. The packaging system of any one of claims 27 to 46, wherein all of or substantially all of the paper-based tray is recyclable.

48. The packaging system of any one of claims 27 to 47, wherein the all of or substantially all of the paper-based tray is made of molded pulp.

49. The packaging system of any one of claims 27 to 48, comprising the drug delivery device, wherein the at least a portion of the drug delivery device is disposed in the paper-based tray.

50. The packaging system of claim 49, wherein the drug delivery device is an autoinjector.

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