Packaging for drug delivery devices

Abstract

The intermediate bulk shipping container includes a box having an interior cavity and at least one tray including a body defining a plurality of recesses, each of the plurality of recesses being dimensioned to accommodate a drug delivery device. The body of the at least one tray defines more than four recesses.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Provisional Patent Application No. 63 / 328,099, filed April 6, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery devices and, more particularly, to packaging assemblies and / or configurations for drug delivery devices. [Background technology]

[0003] To deliver a liquid drug to a patient, a drug delivery device such as an injector is used. When actuated, the drug delivery device expels a drug stored in an internal reservoir, such as a pre-filled syringe ("PFS"), through a needle, cannula, or other delivery member into the patient. Some drug delivery devices, such as a pen autoinjector or an on-body injector, can be placed adjacent to the patient's skin to deliver the drug over a period of time through an injection needle or some other means. The drug delivery device can be placed near tissue in the patient's abdomen, thigh, arm, or some other part of the patient's body.

[0004] Often, such drug delivery devices are shipped to a separate facility where additional processing steps (e.g., labeling) and / or end-user packaging may be performed. Manufacturers may use small shipper packages (e.g., packages containing four devices within them). Such intermediate packaging may result in inefficiencies since an individual must carefully physically remove the adhesive or label from the packaging and then remove the device to perform additional processing and / or repackaging steps. Such packaging is often discarded at this point, which may result in waste and excess packaging. Furthermore, in some environments, some manufacturers may preassemble a number of devices, place them in containers with foam or other insulating materials, and store these containers refrigerated until they are ready for final processing. These devices are often prone to shifting and rubbing against each other while in this packaging, which may lead to scratches and / or unintended manual manipulation thereof. Furthermore, such packaging may not be conducive to automated processes since the devices do not have a uniform orientation while being placed in these containers, which may lead to environmental and cost concerns.

[0005] The present disclosure describes packaging and corresponding techniques for drug delivery devices that embody advantageous alternatives to existing packaging and techniques and that may address one or more of the problems or needs noted herein. Summary of the Invention [Means for solving the problem]

[0006] According to a first aspect, the intermediate bulk shipping container includes a box having an interior cavity and at least one tray including a body defining a plurality of recesses, each of the plurality of recesses being dimensioned to accommodate a drug delivery device. The body of the at least one tray defines more than four recesses.

[0007] In some embodiments, at least one tray may include a location notch formed on the body.

[0008] In some approaches, the at least one tray includes a plurality of trays, each of which may be stackable such that a plurality of trays are disposable within the interior cavity of the box.

[0009] In these and other embodiments, a lid may be provided to cover at least one of the trays, and in some embodiments, the lid may include a lid positioning notch.

[0010] In some approaches, the lid may be constructed from an antistatic material.

[0011] In some approaches, a method of processing a plurality of drug delivery devices is provided, comprising completing a first process step in which the plurality of drug delivery devices are at least partially assembled. An intermediate process step is completed using the aforementioned intermediate bulk transport container. A subsequent process step is completed in which the plurality of drug delivery devices are prepared for administration. In some examples, the intermediate process step may include transporting the plurality of drug delivery devices to a secondary location. Further, in some examples, the subsequent process step may include at least one of applying at least one label to each of the plurality of drug delivery devices or repackaging at least one of the drug delivery devices into an end user container.

[0012] According to an additional aspect, a medication processing system is provided that includes at least one tray. The at least one tray includes a body defining a plurality of recesses, each of the plurality of recesses being dimensioned to accommodate a medication delivery device. The body further defines at least one sidewall at least partially surrounding each of the plurality of recesses. The at least one tray further includes a device removal facilitation feature at least partially formed on the at least one sidewall. The body of the at least one tray defines more than four recesses.

[0013] The above needs are met, at least in part, by the provision of packaging for drug delivery devices as described in the detailed description below, particularly when considered in conjunction with the drawings. [Brief description of the drawings]

[0014] [Figure 1] 1 illustrates an exemplary intermediate bulk shipping container according to various embodiments. [Diagram 2] 2 illustrates an exemplary tray, drug delivery device, and lid for use with the exemplary intermediate bulk shipping container of FIG. 1 in accordance with various embodiments. [Diagram 3] 3 illustrates a cross-sectional perspective view of the exemplary tray of FIG. 2 in accordance with various embodiments. [Figure 4] 4 illustrates a perspective view of a portion of the exemplary tray of FIGS. 2 and 3 in accordance with various embodiments. FIG. [Diagram 5] 1 shows a perspective view of an exemplary medication processing system according to various embodiments. [Figure 6] 6 illustrates a perspective view of an exemplary lid for use with the exemplary intermediate bulk shipping container of FIGS. 1-5 in accordance with various embodiments. [Figure 7] 1-6 in a pre-shipment configuration according to various embodiments. [Figure 8] 1-7 in packaging according to various embodiments. [Figure 9] 1-8 during packaging according to various embodiments. [Figure 10] 13 illustrates an alternative tray for use with an alternative drug delivery device design according to various embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Those skilled in the art will appreciate that the elements in the figures are depicted for simplicity and clarity and are not necessarily 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 help improve understanding of the 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 not overly 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 order of occurrence, although those skilled in the art will appreciate that such specificity with respect to the order is not actually required. It will also be appreciated that the terms and expressions used herein have the ordinary technical meaning that those skilled in the art of the above-mentioned art would recognize for such terms and expressions, unless a different specific meaning is otherwise expressly stated herein.

[0016] Generally speaking, in accordance with these various embodiments, a bulk intermediate package for drug delivery devices is provided that safely transports these devices in an organized arrangement. The packages described herein advantageously include multiple recesses (e.g., more than four, e.g., 8, 12, 16, 24, etc.) and may be stackable, reusable, and modular in nature. Furthermore, such packages allow users and / or automated or semi-automated processes to quickly remove the devices from the package in a single, continuous motion. The components of the package also ensure that each drug delivery device is properly placed therein, thus ensuring that the devices remain safe and can be quickly removed from the package.

[0017] The drug delivery device delivers a drug, which may be referred to herein as a drug or drug product. The drug may be, but is not limited to, various biological substances, such as peptides, peptibodies, or antibodies. The drug may be in fluid or liquid form, although the present disclosure is not limited to a particular state. Various implementations and configurations of the drug delivery device are possible. For example, the present disclosure describes a drug delivery device in the form of a single-use disposable injector. In other embodiments, the drug delivery device may be configured as a multiple-use reusable injector. The drug delivery device may be operable for self-administration by the patient or administration by a caregiver or formally trained healthcare provider (e.g., a doctor or nurse). Additionally, the drug delivery device may take the form of an auto-injector or pen-type injector, and thus may be held in the user's hand for the duration of the drug delivery or administration.

[0018] Turning now to the figures, an intermediate bulk shipping container 100 is provided for use in shipping completed (i.e., fully assembled) and / or partially completed (i.e., partially assembled) drug delivery devices 10. More specifically, the container 100 may include a box 101 having an internal cavity 102 and at least one tray 110. Furthermore, in some embodiments, the container 100 may additionally include a lid 140 and an optional bag 150, as described in more detail below. The tray 110 includes a body 111 that defines a number of recesses 114, each of which accommodates and / or receives an individual drug delivery device 10. As shown in the figures, in some embodiments, the tray 110 may include sixteen recesses 114, although any number of recesses 114 may be provided. However, it will be appreciated that since the container 100 is used for bulk shipping, the tray 110 may include more than four recesses 114.

[0019] The body 111 of the tray 110 includes a first end 111a, a second end 111b, a first side 111c, and a second side 111d that cooperate to define an outer wall. Each of the recesses 114 is divided by a sidewall 116 that is shaped and dimensioned to correspond to the shape and size of the drug delivery device 10. The tray 110 further includes a device removal facilitation feature 118 in the form of a groove and / or an internal contoured cavity that extends the length of the body 111 of the tray 110. More specifically, the groove 118 extends through each sidewall 116 and, optionally, also extends the length below the recesses 114. Additionally, the groove 118 extends on the sidewall 116 of the tray 111 that is formed on the first and second sides 111c, 111d. In some embodiments, grooves 118 may be sized to receive fingers or other gripping and / or removal mechanisms in implementations where an automated and / or semi-automated process is provided. In particular, grooves 118 facilitate cascade and / or swipe removal of devices 10, eliminating the need to remove each individual device 10 via a personalized pulling or gripping action.

[0020] 3 and 4, the tray 110 may further include an orientation feature 120 disposed in or near each recess 114. In the illustrated embodiment, the orientation feature 120 is disposed near the first end 111a of the tray 111, although other alternative locations are possible. In the illustrated embodiment, the orientation feature 120 is in the form of an undercut area that receives a portion of the device 10. This undercut area may be shaped and sized such that only a particular end (e.g., a "top" end) of the device 10 may fit therein, meaning that if the device 10 is placed in the recess 114 in an incorrect or upside-down orientation (e.g., with the "bottom" end disposed therein), the device 10 will be prevented from fully nesting in the recess 114. Notably, the tray 110 may also include inspection notches 122 positioned along the first and second sides 111c, 111d. These notches 122 may allow a user to visually inspect the devices 10 to ensure that they are fully seated within their respective recesses 114. Once the devices 10 are placed into the recesses 114, the user may look sideways at the inspection notches 122 to identify if any devices protrude from their respective recesses 114. In some embodiments, a user may inspect the trays 110 manually, while in other embodiments the inspection process may be automated using an imaging system and / or a computing system. Other examples are possible.

[0021] In some embodiments, the tray 110 may be constructed from a reusable material (e.g., a polymeric material). Additionally, in some embodiments, the tray 110 may be constructed from a material that has antistatic properties, thus reducing the possibility of unwanted debris adhering to the drug delivery device 10. The tray 110 may be rigid or semi-rigid and may support additional trays in a nested or stacked configuration (see, e.g., FIGS. 7-9). Thus, the tray 110 may be used in a modular manner to accommodate any desired number of devices 10 by simply stacking the additional trays 110 on top of each other.

[0022] 2 and 4, the tray 110 may further include a positioning notch 124. In the illustrated embodiment, the positioning notch 124 is in the form of a notch between the first end 111a and the first side 111c of the tray, although other locations are possible. The positioning notch 124 may be used to ensure that the tray 110 itself is properly oriented relative to other components, such as, for example, other trays 110 and / or other processing components. More specifically, when multiple trays are stacked on top of each other, a user (or an automated or semi-automated process) may quickly identify whether the tray 110 is properly oriented by identifying whether the positioning notch 124 is present at a corner when viewed from a plan or front view. If a portion of the body 111 of the tray 110 is visible, the user may quickly rotate the tray 110 to the correct orientation before performing additional processing steps. As a result, the user may ensure that both the tray 110 and the devices 10 disposed thereon are all properly oriented.

[0023] 2 and 4, the tray 110 further includes visual identifiers 126 formed within or along each recess 114. In the illustrated embodiment, the visual identifiers 126 are in the form of consecutive numbers that may be seen by a user and / or an imaging system. These visual identifiers 126 may enable a user and / or an imaging system to easily identify recesses 114 that require attention (e.g., if a device 10 is missing and / or improperly oriented). Other examples are possible.

[0024] 2 and 6, a lid 140 may be used to cover the tray 110. The lid 140 is sized to rest on top of the tray 110 and may include a recess (not shown) on its underside that corresponds to the shape of the device 10. Additionally, the top side 140a of the lid 140 includes an outer ledge 142 as well as a protrusion 146. The outer ledge 142 may have a size and shape that corresponds to the underside of the tray 110 such that the outer ledge 142 may abut within a portion of the tray 110 when the lid 140 is used and the trays 110 are stacked on top of each other. Additionally, the protrusion 146 is positioned and sized to engage a corresponding cavity formed in the underside of the tray 110. When so positioned, the tray may nest and / or otherwise be coupled within the tray 110 that is stacked above. In other embodiments, the tray 110 may be releasably secured to the lid 140 by any number of suitable techniques, such as, for example, a friction fit coupling.

[0025] In some embodiments, the lid 140 further includes a lid positioning notch 144 along the outer edge 142. In these embodiments, the lid positioning notch 144 may have a similar shape and / or size as the positioning notch 124 of the tray 110. Thus, when one or more lids 110 are placed on one or more trays 110, a user may still be able to quickly identify if any trays 110 or lids 140 are incorrectly oriented by viewing the trays 110 from above. Other examples are possible.

[0026] As shown in FIGS. 7-9, the bag 150 may be sized to receive any number of trays 110 and / or lids 140. The bag 150 allows one or more trays 110 to be quickly moved in and out of the box 101. As mentioned above, the bag 150 is optional. The disclosed configuration of the lid positioning notches 144 and the positioning notches 124 of the tray 110 stabilizes the load such that the bag 150 is not necessary, so the bag 150 is optional. As shown in FIGS. 8 and 9, the tray 110, lid 140, and bag 150 may be placed in the box and a user may visually inspect the arrangement to ensure that the positioning notches 124 are properly oriented in each of the tray 110 and lid 140.

[0027] In use, the trays 110 may be provided at a manufacturing and / or assembly site where a large number of drug delivery devices 10 are processed. In such an environment, a first process step may be initiated in which the drug delivery devices 10 are partially and / or fully assembled. A desired number of devices 10 may then be placed into the recesses 114 of one or more trays 110, after which an intermediate process step may be performed. In some embodiments, this intermediate process step may include transporting one or more trays 110 (as well as any additional packaging, such as boxes 101 and / or any bags 150) to a different location. More specifically, one or more trays 110 may be transported to a storage facility until further processing is desired, one or more trays 110 may be transported to a different location within the manufacturing and / or assembly site for further processing, and / or one or more trays 110 may be transported to a different facility, such as, for example, a labeling facility, a laboratory, a medical facility, etc. One or more trays 110 may be used during the intermediate processing step to facilitate transport of bulk quantities of devices 10.

[0028] In some embodiments, the method may further include the completion of subsequent processing steps. For example, after one or more trays 110 have been transported, final steps such as labeling each device 10, repackaging the devices 10 into their final (e.g., end-user) packaging, etc. may occur. As previously described, in embodiments in which the devices 10 are removed from the trays 110, the user may quickly remove the devices in a single continuous motion after removing one or more trays 110 from any bags 150 and any lids 140 therefrom. In some embodiments, the subsequent processing steps may be performed at least in part by a drug processing system 200, as shown in FIG. 5. The system 200 may have automated and / or semi-automated processing capabilities that reduce overall processing time. In these embodiments, the system 200 may include a platform 202 that accepts and / or supports the trays 110 and an arm 210. In some arrangements, the platform 202 may be in the form of a conveyor belt, a fixed table, a workstation, etc., and may include a recess (not shown) or other positioning mechanism to accept and position the trays 110 in a desired position on the platform 202. As one example, the platform 202 may include a recess having an angled portion that corresponds to a positioning notch 124 formed on the tray 110 to ensure that the tray 110 is positioned correctly.

[0029] The arm 210 may be positioned above the tray 110 while the tray 110 is disposed on the platform 202. In some embodiments, the arm 210 may include a telescoping member that selectively raises and / or lowers the gripping mechanism 212. More specifically, the gripping mechanism 212 may be in the form of a finger member having a curvature that can engage a recess 114 formed on the tray 110. By properly orienting the tray 110 on the platform 202, the arm 210 may be programmed to lower the gripping mechanism 212 into the recess 114 and complete a swiping motion to remove all of the devices 10 disposed on the tray 110, which may then be retrieved and used as desired. Advantageously, tray 110, and especially orienting mechanism 120, ensures that devices 10 are all oriented in the same direction, so that a user and / or system does not have to invert or flip devices 10 to properly complete additional processing steps, such as labeling (which may require a label to be adhered to device 10 in a particular location and orientation) and / or subsequent packaging (which may require device 10 to be disposed in a particular configuration), potentially reducing the overall time required to process these devices 10, potentially resulting in significant cost savings.

[0030] Compared to conventional disposable non-bulk packaging, the packaging described herein advantageously allows a user or automated process the ability to remove all of the devices therefrom in a single swipe and / or cascade action, as opposed to the individual scooping actions previously used. Such swipe and / or cascade action results in substantially reduced processing times and allows for the incorporation of automated processing systems that were not previously feasible. Such packaging may also be used for storage and / or after any intermediate processing steps have been completed. More specifically, the packaging may be used for applications such as clinical trials, shipment to distributors, and / or foreign markets. In such examples, the reuse of the packaging may reduce overall costs.

[0031] Moreover, the container 100 of the present invention advantageously incorporates stackable trays that are modular in nature. Any number of trays may be stacked in a shipping box to transport a desired number of drug delivery devices. Moreover, such trays may be used as storage devices even after additional processing steps have been performed, thereby reducing the need for additional packaging and / or shipping materials. The lid may be easily detached from the tray and, like the tray itself, may allow a user to quickly identify whether the tray and lid are oriented in a similar direction prior to placing them in a shipping / shipping box or other packaging. So positioned, this visual identifier ensures proper orientation when performing automated (or semi-automated) processing steps where the relative alignment of the components is important.

[0032] Additionally, as shown in FIG. 10, the packaging described herein may be configured for use with any number of different drug delivery devices having a variety of sizes, shapes, and / or configurations.

[0033] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. The term drug, as used herein, may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, biological equivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following exemplary list of drugs should not be considered exhaustive or limiting.

[0034] The drug is contained within a reservoir. In some cases, the reservoir is a primary container into which the drug is filled or pre-filled for treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0035] In some embodiments, the reservoir of the drug delivery device may be loaded with or the device may be used with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez) or FULPHILA (pegfilgrastim-bmez).

[0036] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoietin. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin stimulating proteins include erythropoietin and its variants, analogs or derivatives 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. Erythropoietin stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), Epoetin 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 and molecules or variants or analogs thereof.

[0037] 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, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., which particularly inhibit activities mediated by binding of IL-4 and / or IL-13 to its receptor; 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., epratuzumab (CAS Registry Number 501423-23-0). 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, including, but not limited to, human CD22 specific IgG antibodies, particularly including, but not limited to, the human CD22 specific fully humanized antibody of HuMax; IGF-1 receptor specific antibodies, including, but not limited to, anti-IGF-1R antibodies, peptibodies and related proteins; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like, including, but not limited to, those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells, including, but not limited to, the B7RP specific fully human monoclonal IgG2 antibody, including, but not limited to, the fully human IgG2 monoclonal antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1 (also referred to as "B7RP-1" and B7H2, ICOSL, B7h and CD275); e.g., 145c7, HuMax IL-15 specific antibodies, such as humanized monoclonal antibodies, peptibodies, related proteins, and the like, including, but not limited to, IL-15 antibodies and related proteins;IFN gamma specific antibodies, including but not limited to, human IFN gamma specific antibodies, including but not limited to, fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, as well as 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; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) 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 monoclonal antibodies; 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; and proteins that bind to c-Kit and / or other stem cell factor receptors, including, but not limited to, including, but not limited to, c-Kit specific antibodies, peptibodies, related proteins, etc.; OX40L specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, stimulating de novo erythropoiesis Protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered ® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alpha); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb);Tarceva® (erlotinib);Roferon-A®-(interferon alpha-2a);Simulect® (basiliximab);Prexige® (lumiracoxib);Synagis® (palivizumab);145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507);Tysabri® (natalizumab, anti-α4 integrin mAb);Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb);ABthrax®;Xolair® (omalizumab);ETI211 (anti-MRSA mAb);IL-1 trap (Fc portion of human IgG1 and extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, an anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388; anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage I fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;Anti-GDF-8 human mAb (MYO-029);Anti-GM-CSF receptor mAb (CAM-3001);Anti-HepC mAb (HuMax HepC);Anti-IFNα mAb (MEDI-545, MDX-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;Anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VE; GFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0038] In some embodiments, the drug delivery device may contain or be used with sclerostin antibodies, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used 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, OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), 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), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies to the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell-engaging (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 can contain or be used with an APJ large molecule agonist, such as, but not limited to, apelin or an analogue 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 can contain or be used 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 with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap, such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), a new bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecamtiv mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the contractile mechanism 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 sotorasibe (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 reduces lipoprotein(a), also known as Lp(a), or another product that contains small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with another product, including Amjevita™ or Amgevita™ (formerly ABP501) (mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or a mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 160 or a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119 or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119 or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133 or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171 or a growth differentiation factor 15 (GDF15) analog.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176 or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 199 or a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively activate the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multispecific FAP x 4-1BB targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may house or be used in conjunction with AMG 509 or another product containing a bivalent T cell engager and designed using XmAb® 2+1 technology.In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 562 or another product containing a half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with efavalukin 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 in conjunction with AMG 596 or CD3xEpidermal Growth Factor Receptor vIII (EGFRvIII) BiTE® (bispecific T cell. In some embodiments, the drug delivery device may contain or be used with another product containing a half-life extended (HLE) anti-human CD33 x anti-anti-human CD3 BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 673 or a half-life extended (HLE) anti-human CD33 x anti-anti-human CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 701 or 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 another product containing AMG 757 or 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 house or be used in conjunction with AMG 910 or another product containing the half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0039] The drug delivery devices, assemblies, components, subsystems and methods have been described in terms of, but not limited to, exemplary embodiments. The detailed description should be construed as merely exemplary and does not describe all possible embodiments of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, but such embodiments still fall within the scope of the claims that define the invention disclosed herein.

[0040] Those skilled in the art will understand that various modifications, alterations and combinations may be made to the above-described embodiments without departing from the spirit and scope of the present invention disclosed herein, and that such modifications, alterations and combinations are to be construed as falling within the scope of the concept of the present invention.

Claims

1. Intermediate bulk transport container, A box having an internal cavity, A tray comprising at least one body defining a plurality of recesses, each of which is sized to accommodate a drug delivery device, The body of the at least one tray defines four or more recesses, Intermediate bulk transport container.

2. The intermediate bulk transport container according to claim 1, wherein the at least one tray includes a positioning notch formed on the main body.

3. The intermediate bulk transport container according to claim 1 or 2, wherein the at least one tray comprises a plurality of trays, each of which is stackable such that the plurality of trays can be arranged in the internal cavity of the box.

4. The intermediate bulk transport container according to claim 1 or 2, further comprising a lid fitted to cover at least one of the trays.

5. The intermediate bulk transport container according to claim 4, wherein the lid includes a lid positioning notch.

6. The intermediate bulk transport container according to claim 1 or 2, wherein the at least one tray is constructed from an antistatic material.

7. A method for processing multiple drug delivery devices, Completing a first process step in which the plurality of drug delivery devices are at least partially assembled, Completing the intermediate process step using the intermediate bulk transport container described in claim 1 or 2, The process includes completing a subsequent process step in which the plurality of drug delivery devices are prepared for administration, method.

8. The method according to claim 7, wherein the intermediate process step includes transporting the plurality of drug delivery devices to a secondary location.

9. The method according to claim 7, wherein the subsequent process step includes at least one of affixing at least one label to each of the plurality of drug delivery devices, or repackaging at least one of the drug delivery devices in an end-user container.

10. A drug processing system, At least one tray, A body comprising a plurality of recesses, each of which is sized to accommodate a drug delivery device, and the body further comprising at least one side wall that at least partially surrounds each of the plurality of recesses, A device removal facilitating mechanism formed at least partially on at least one of the side walls, It comprises at least one tray including, The body of the at least one tray defines four or more recesses, Drug processing system.

11. The drug processing system according to claim 10, wherein the device removal facilitation mechanism includes a groove extending along the length of the body of the tray.

12. The drug processing system according to claim 10 or 11, further comprising an orientation mechanism disposed inside or near each of the plurality of recesses, wherein the orientation mechanism is adapted to orient each of the drug delivery devices to a first position.

13. The drug processing system according to claim 12, wherein the orientation mechanism includes an undercut portion.

14. The drug processing system according to claim 10 or 11, further comprising an arm positioned above at least one tray, the arm including a gripping mechanism adapted to continuously retrieve each of the drug delivery devices disposed within the plurality of recesses.

15. Furthermore, the drug processing system according to claim 14, comprising a platform adapted to support the at least one tray.

16. The drug processing system according to claim 15, wherein the platform is further adapted to transport the at least one tray to a subsequent processing station.

17. Furthermore, the drug processing system according to claim 10 or 11, further comprising a visual identifier disposed inside each of the plurality of recesses.

18. Furthermore, the drug processing system according to claim 10 or 11, further comprising a positioning notch formed on the main body.

19. The drug processing system according to claim 10 or 11, wherein at least one of the trays is reusable.

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