Storage systems and methods for storing and transporting pharmaceuticals

Abstract

Regarding methods for packaging, storing, and transporting pharmaceuticals. [Solution] A storage system for storing drugs includes a container, at least one passive cooling system, and an active cooling system. The container has an internal volume for accommodating at least one drug. The at least one passive cooling system is located inside the container and includes a phase-change material. The active cooling system is operably coupled to the container and, when in operating mode, maintains a desired temperature within the internal volume of the container.

Description

Technical Field

[0001] Cross - reference to related applications Priority is claimed to U.S. Provisional Patent Application No. 63 / 028,875, filed May 22, 2020, the entire content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to pharmaceutical products, and more specifically, to methods of packaging, storing, and transporting pharmaceuticals.

Background Art

[0003] Pharmaceuticals (also called drugs or medicines) are administered to treat various conditions and diseases. Many drugs must be kept at low temperatures (e.g., temperatures between about 2°C and about 8°C), in a frozen state, and / or in a lyophilized state (e.g., temperatures below about - 20°C) prior to use to ensure the effectiveness of the drug upon administration. Thus, these drugs often must remain at low temperatures during transportation and distribution. In some environments, drugs may be transported by air cargo. Such deliveries typically involve passive containers that are cooled by passive cooling elements such as dry ice. Air cargo usually involves relatively small amounts of cargo, so these delivery systems can usually be loaded and unloaded relatively quickly. Thus, drugs cannot be exposed to warm environments such as warehouses where the drugs are not cooled for long periods of time. Thus, as long as the passive container is used within its limited time of use, the drugs can be safely stored and / or transported. However, delivery by air cargo can result in increased delivery costs and may not be suitable for large cargo sizes. As another example, delivery by air cargo can be difficult to schedule when the demand for air cargo space is high. Additionally, in some situations, air cargo can be delayed in addition to flight delays, and these delays can be longer than the time the passive cooling element can maintain the low temperature of the drug, resulting in the drug potentially being exposed to harmful temperatures.

[0004] In other environments, drugs may be transported by sea freight in which large quantities of the product are placed in reefer (i.e., refrigerated) containers. These reefer containers may be cooled by an active cooling system that maintains the internal volume of the container at a desired temperature level. Such active cooling systems are usually electrically powered. During the packaging and transport process, reefer containers may undergo transition periods when the power is cut off and / or unavailable. For example, this may occur during packaging, palletizing, labeling, loading and / or unloading of the reefer container. Even in these cases, drugs may be exposed to ambient temperatures that risk heating the drugs to potentially harmful levels. Furthermore, during transport, reefer containers may encounter unplanned, unscheduled, or last-minute "power-off" conditions where the active cooling system fails to maintain the temperature within the internal volume, for example, due to a loss of power. These situations can also lead to the drugs being exposed to potentially harmful ambient temperatures. [Overview of the project] [Means for solving the problem]

[0005] As will be further detailed below, this disclosure describes a system and method for storing drugs that embodies a favorable alternative to existing systems and methods, which can address one or more of the problems or requirements described herein and also provide other benefits and advantages.

[0006] According to a first embodiment, a storage system for storing a drug includes a container, at least one passive cooling system, and an active cooling system. The container has an internal volume for accommodating at least one drug. The at least one passive cooling system is located inside the container and includes a phase-change material. The active cooling system is operably coupled to the container and, when in operating mode, maintains a desired temperature within the internal volume of the container.

[0007] In some examples, phase-change materials are transitionable between solid and liquid states. In these examples, the phase-change material is composed of at least one drug before it is placed within the container's internal volume.

[0008] In some examples, the storage system may further include at least one drug container placed within the internal volume of the container. The at least one drug container is sized to store at least one drug. Furthermore, in some examples, the at least one drug container may include several side walls, a top surface, and a bottom surface. At least one passive cooling system may be operably coupled to at least one of the multiple side walls, top surface, or bottom surface. In some examples, the at least one passive cooling system is detachably located within an opening formed in the at least one drug container. In other embodiments, the at least one passive cooling system is detachably located within a pocket formed in the at least one drug container. The pocket may be on the internal and / or external surface of the at least one drug container.

[0009] In some examples, at least one drug container may further include at least one expanded polystyrene or molded polyurethane component. In some examples, the storage system may transition to a passive cooling state in which at least one passive cooling system maintains a desired temperature within the container's internal volume. Furthermore, in some examples, the storage system may include an electrical connector operably coupled to an active cooling system to provide power to the active cooling system.

[0010] According to a second embodiment, a method for delivering drugs includes the steps of: placing at least one passive cooling system in a container having an internal volume; placing drugs in the internal volume of the container; connecting an active cooling system to the container; and transporting the container to a different location. The at least one passive cooling system includes a phase change material.

[0011] The above needs are at least partially met through the provision of the packaging and storage of the drugs described in the following detailed description, which will be considered in conjunction with the drawings. [Brief explanation of the drawing]

[0012] [Figure 1] Schematic diagrams of exemplary drug storage systems with exemplary drug containers, according to various embodiments, are shown. [Figure 2] Figure 1 shows perspective views of exemplary drug containers according to various embodiments. [Figure 3] Schematic diagrams of exemplary drug containers, including those accommodating additional passive cooling systems, are shown in Figures 1 and 2, according to various embodiments. [Figure 4] Figure 3 shows perspective views of exemplary drug containers according to various embodiments. [Figure 5] A schematic diagram of a second exemplary drug storage system having exemplary drug containers in various embodiments is shown. [Figure 6] The graph shows the surface temperature over time of drugs stored in exemplary drug containers according to various embodiments. [Modes for carrying out the invention]

[0013] Those skilled in the art will understand that the elements in the figures are drawn for simplification and clarity and are not necessarily drawn to a specific scale. For example, the dimensions and / or relative positions of some elements in the figures may be exaggerated relative to others to help improve the understanding of the various embodiments of the invention. Also, common but well-understood elements that are useful or necessary in commercially viable embodiments are often omitted so as not to interfere too much with the illustrations of these various embodiments. Furthermore, it will be recognized that certain actions and / or processes may be described or shown in a specific order of occurrence, but those skilled in the art will understand that such specificity regarding order is not actually necessary. It will also be understood that the terms and expressions used herein have the ordinary technical meanings that those skilled in the art would give to such terms and expressions, as described above, unless a different specific meaning is explained herein.

[0014] Generally, according to these various embodiments, storage systems for storing drugs are provided that maintain a sub-zero temperature of the frozen drug using both passive and active cooling systems during loading, unloading, power off, and other situations that occur during long-distance and long-duration transport (e.g., during sea transport). The systems and methods described herein protect the drug from mechanical damage from the moment it is placed in the packaging system until it is transferred to the freezer unit at the end of transport. During loading, unloading, power off, and other potential events, the active cooling mechanism may not be available, and the drug may be exposed to ambient room temperature for extended periods (e.g., 10 hours or more). If left unprotected during these times, the temperature of the drug may exceed its melting point by the time it is cooled again by the active cooling mechanism.

[0015] Referring to the figures, a storage system 100 for storing drug 101 is presented according to these various embodiments. The storage system 100 includes a container 102, any number of drug containers or boxes 110, and any number of passive cooling systems 120. The container 102 may be in the form of a refrigerated and / or chilled cargo or delivery container, such as a reefer container, and defines an internal volume 102a for accommodating and storing several drug containers 110. In some examples, the container 102 includes an active cooling system 104, which may be a refrigeration or freezer unit, and an air compressor, etc. The container 102 is configured to provide long-term cooling of the drug containers 110 by using the active cooling system 104 to maintain the temperature within the internal volume 102a of the container 102 during delivery and transport. The active cooling system 104 may be coupled with a power connector (not shown) to supply power to the active cooling system 104. Container 102 may include any number of binding mechanisms (not shown) to securely hold the drug container 110.

[0016] The drug container 110 includes an internal volume 110a for holding at least one drug 101. In the illustrated example, the drug 101 is held in a drug bag or box 111. The drug container 110 includes several side walls 112, a top or lid 114, and a bottom or base 116. The drug container 110 may be made of any number of suitable materials, such as double-walled corrugated material. Other examples are possible.

[0017] The drug container 110 is sized to accommodate at least one passive cooling system 120. More specifically, the passive cooling system 120 is in the form of a phase-change material having a melting point of approximately -23°C. In other words, the phase-change material changes between a solid state and a liquid state at this melting point. Generally, the phase-change material is configured to absorb energy when heated to its melting point, thereby further cooling its surrounding environment (i.e., the drug container 110). The passive cooling system 120 may be housed in a plastic housing or other material in the form of a pouch or brick, and consists of a substantially flat panel or sheet. In the illustrated examples in Figures 1 and 2, the passive cooling system 120 is positioned adjacent to the bottom surface 116 and top surface 114 of the drug container 110. However, as in other examples and as will be further detailed below, the passive cooling system 120 may be positioned relative to the drug container 110 in several configurations.

[0018] Referring to Figure 2, a more detailed description of the drug container 110 and the packaging process will be provided. The drug container 110 may include any number of additional insulating layers to provide additional protection to the drug 101. More specifically, several expanded polystyrene panels 117 may work together to form an inner box 117a placed within the internal volume 110a of the drug container 110, and a molded polyurethane tank 119 may be placed inside the inner box 117a. In the illustrated example of Figure 2, a first passive cooling system 120 is then placed inside the molded polyurethane tank 119. In particular, in some examples, the phase change material of the passive cooling system 120 is initially configured in a solid (i.e., frozen) state before packaging, so that when the drug 101 is packaged in the drug box 111 and placed on the passive cooling system 120, the passive cooling system 120 can immediately cool the drug 101 and maintain a low temperature.

[0019] As shown in Figure 2, the second drug box 111 holds the additional drug 101 and is then placed on top of the first drug box 111. Next, the second passive cooling system 120 is placed on top of the second drug box 111, and the molded polyurethane lid 119a is placed on the molded polyurethane tank 119. Subsequently, an additional expanded polystyrene panel 117 is placed on top of the polyurethane lid 119a, and the top surface 114 of the drug container 110 is folded and secured on the expanded polystyrene panel 117, thereby closing the drug container 110. Any number of these drug containers 110 can be packaged, assembled, loaded into a container 102, and then delivered or transported to the desired location.

[0020] Referring briefly to Figures 3 and 4, instead of the expanded polystyrene panel 117, an additional passive cooling system 120 is positioned inside the drug container 110 in contact with the side wall 112. In this configuration, the drug container 110 can receive further cooling of the drug 101 as needed.

[0021] In a typical operation, during the delivery and transportation of the drug 101, the active cooling system 104 maintains the desired temperature within the internal volume 102a of the container 102 in the operating mode. Thus, the drug 101 (in addition to the phase change material) remains frozen in a solid state. However, when the storage system 100 transitions to a passive cooling state where the active cooling system 104 does not operate (e.g., during a power-off state or during loading and / or unloading), the passive cooling system 120 maintains the temperature within the internal volume 102a of the container 102 for an extended period. The passive cooling system 120 can maintain a low temperature for an extended period, such as for about 10 hours to about 30 hours, until the phase change material melts and the desired temperature of the drug 101 can no longer be maintained. As another example, the passive cooling system 120 can maintain the desired temperature for about 12 hours to about 28 hours, or about 14 hours to about 26 hours, or about 16 hours to about 24 hours, or about 18 hours to about 22 hours, or other exemplary times. During these passive cooling states, when the active cooling system 104 resumes power and returns to an operating state, the active cooling system 104 again maintains the temperature within the internal volume 102a of the container 102 while also absorbing cooling energy into the phase change material of the passive cooling system 120, returning it to a solid state and / or its full cooling capacity.

[0022] As described above, the passive cooling system 120 can continuously keep the drug 101 below its melting temperature. As shown in FIG. 6, when the external environment rises to room temperature (e.g., during loading, unloading, or a power outage), the phase change material of the passive cooling system 120 absorbs energy in the form of heat and further cools the drug 101. In an example where an additional passive cooling system 120 is used, the internal volume 110a of the drug container 110 can remain below the melting point of the drug 101 for about 72 hours or more. Other examples are also possible.

[0023] Advantageously, the passive cooling system can be "charged" by the active cooling system 104. Thus, the passive cooling system 120 can be used multiple times without significant degradation.

[0024] In particular, in some examples, by providing the phase change material in a solid state during packaging, the drug container 110 does not need to be immediately placed into the container 102. Rather, some or all of the desired drug containers 110 can be collected without the concern that the drug 101 may melt before being loaded into the container 102. Further, when the system 100 arrives at the desired location, the drug container 110 is unloaded from the container 102, transferred to a temporary storage location (e.g., a dock, a warehouse, etc.), and then can be placed back into the freezer or refrigerator. During this time, the passive cooling system 120 again serves to maintain the low temperature of the drug 101.

[0025] The storage system 100 can include any number of alternative designs, features, and / or additional components. For example, referring to FIG. 5, a second exemplary drug container 210 that can be used in the system 100 is provided. The drug container 210 can include features similar to those of the drug container 110, and thus, such similar features are understood to be indicated by reference numerals having the same two-digit suffix. Accordingly, such components will not be described in as much detail when referring to the drug container 210. Further, any of the components of the drug container 210 can be used interchangeably with any of the components of the drug container 110.

[0026] In the drug container 210, any number of side walls 212, top surface 214, and / or bottom surface 216 can each include one or more openings 212a, 214a, 216a dimensioned to accommodate a passive cooling system 220. Further, as shown in the bottom surface 216, some of the openings 216a can be provided to accommodate a plurality of separate passive cooling systems 220. Alternatively, the bottom openings 216a can be used for transportation. More specifically, the openings 216a can be dimensioned to accommodate the forks of a forklift or similar components. Other examples are possible.

[0027] In some examples, the passive cooling system does not need to be directly coupled to the drug container. More specifically, any number of passive cooling systems can be arranged within the internal volume 102a of the container 102 in any number of configurations, such as arranging the cooling packs along the outer periphery of the internal volume, or being coupled to the side walls to form a shell. Furthermore, in some examples, the passive cooling system can be directly coupled to the drug without using a drug container. In these examples, the passive cooling system itself may function as a container and may be secured by fasteners, straps, buckles, etc. Other examples are also possible.

[0028] With the container configured in this way, by incorporating a phase-change material into one or more passive cooling systems, the drug can be reliably kept below its freezing point. Furthermore, the phase-change material rapidly equilibrates the temperature of the drug to the temperature of the container after it is placed inside. More specifically, since palletizing, labeling, and loading drug containers into containers can take a long time (e.g., several hours), a long amount of time is also required for the internal volume of the container to be actively cooled to the desired temperature. By using the phase-change material in its solid state inside the drug container, the internal volume of the container has a low temperature initially, so when activated, the active cooling system can lower the temperature of the internal volume of the container more rapidly. Depending on the cooling requirements of the drug container, any number of passive cooling systems can be used and placed on any surface of the drug container. Furthermore, the passive cooling systems can be placed outside the drug container by external pockets placed on the side walls, top and / or bottom, or simply by contacting the external surface of the desired container wall.

[0029] It will be understood that the systems and methods described herein can be used for the storage and transport of drugs in a variety of conditions, including, but not limited to, drug products after mixing and / or other finishing processes have been completed, active pharmaceutical ingredients that will be mixed and / or finished after delivery, components or raw materials used in drugs, or conditions or components related to other drugs.

[0030] The above description relates to various devices, assemblies, components, subsystems, and methods of use associated with drug delivery devices. Devices, assemblies, components, subsystems, methods, or drug delivery devices may further include, or be used with, drugs specified below, as well as their generic and biosimilar equivalents. As used herein, the term "drug" is interchangeable with other similar terms and may refer to any type of agent or therapeutic substance, including conventional and unconventional pharmaceuticals, dietary supplements, supplements, biological preparations, biological activators and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or restrictive.

[0031] 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 therapeutic purposes. The primary container may be a vial, cartridge, basket bottle, bag, pre-filled syringe, or any suitable drug container, drug product container, active pharmaceutical ingredient container, or other drug-related container.

[0032] In some embodiments, the reservoir of a drug delivery device may be filled with colony-stimulating factors such as granulocyte colony-stimulating factor (G-CSF), or the device may be used with such factors. Examples of 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).

[0033] 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 erythrocyte production. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, “erythropoiesis-stimulating protein” means any protein that directly or indirectly causes activation of an erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Examples of erythropoiesis-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. Examples of red blood cell production stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Examples include, but are not limited to, epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and their molecules, variants, or analogues.

[0034] Certain exemplary proteins, including their fusions, fragments, analogues, variants, or derivatives, are described below: OPGL-specific antibodies, peptide bodies, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies (also referred to as RANKL-specific antibodies, peptide bodies, etc.); myostatin-binding proteins, peptide bodies, and related proteins, including myostatin-specific peptide bodies; and IL-4 receptor-specific antibodies, peptide bodies, and related proteins, particularly those that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to their receptors; Interleukin 1 receptor 1 ("IL1-R1") specific antibodies, peptide bodies, and related proteins; Ang2 specific antibodies, peptide bodies, and related proteins; NGF specific antibodies, peptide bodies, and related proteins; CD22 specific antibodies, peptide bodies, and related proteins, etc., especially dimers of human-mouse monoclonal hLL2γ chain disulfide bound to human-mouse monoclonal hLL2κ chain, for example, epratuzumab (CAS registry number 501423-23-0) and human CD22. Human CD22-specific antibodies, including but not limited to human CD22-specific fully humanized antibodies such as CD22-specific fully humanized antibodies; humanized and fully human monoclonal antibodies, including but not limited to humanized and fully human antibodies; IGF-1 receptor-specific antibodies, peptide bodies, and related proteins, including but not limited to anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies that bind to the epitope of the first immunoglobulin-like domain of B7RP-1; B7-related protein 1-specific antibodies, peptide bodies, and related proteins, including but not limited to those that suppress the interaction between B7RP-1 and ICOS, the natural receptor for B7RP-1 on activated T cells (also referred to as "B7RP-1", B7H2, ICOSL, B7h, and CD275); e.g., 146B7, HuMax This includes, but is not limited to, IL-15 antibodies and related proteins, particularly humanized monoclonal antibodies, IL-15 specific antibodies, peptide bodies, related proteins, etc.; human IFNIFN γ-specific antibodies, peptide bodies, and related proteins, including but not limited to γ-specific antibodies, and fully human anti-IFN γ antibodies; TALL-1 specific antibodies, peptide bodies, and related proteins, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH") specific antibodies, peptide bodies, and related proteins; thrombopotiene receptor ("TPO-R") specific antibodies, peptide bodies, and related proteins; and fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF) on the HGF / SF:cMet axis. Hepatocyte growth factor ("HGF")-specific antibodies, peptide bodies, and related proteins, including those targeting HGF / SF (c-Met); TRAIL-R2-specific antibodies, peptide bodies, and related proteins; Activin A-specific antibodies, peptide bodies, and proteins; TGF-β-specific antibodies, peptide bodies, and related proteins; Amyloid-β protein-specific antibodies, peptide bodies, and related proteins; and those that bind to c-Kit and / or other stem cell factor receptors. c-Kit-specific antibodies, peptide bodies, and related proteins, including but not limited to proteins; OX40L-specific antibodies, peptide bodies, and related proteins, including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa or erythropoietin), GLP-1, Avonex® (interferon β-1a), Bexxar® (tositumomab, anti-CD22 monoclonal antibody), Betaseron® (interferon-β), Campath® (aremtuzumab, 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), Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), Vectibix® (panitumumab), Xgeva( (Registered Trademark) (Denosumab), Prolia (Registered Trademark) (Denosumab), Enbrel (Registered Trademark) (Etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate (Registered Trademark) (Romiplostim), Rilotumumab, Ganitumumab, Conatumumab, Brodalumab, Insulin in Solution, Infergen (Registered Trademark) (Interferon alfacon-1), Natrecor (Registered Trademark) (Nesiritide, Recombinant Human Type B Natriuretic Peptide (hBNP)), Kineret (Registered Trademark) (Anakinra), Leukine (Registered Trademark) (Sargamostim, rhuGM-CSF), LymphoCide (Registered Trademark) (Epratuzumab, Anti-CD22 mAb), Benlysta (trademark) (lymphostat B, belimumab, anti-BlyS mAb), Metalyse (registered trademark) (tenecteplase, t-PA analog), Mircera (registered trademark) (methoxypolyethylene glycol-epoetin beta), Mylotarg (registered trademark) (gemtuzumab ozogamicin), Raptiva (registered trademark) (efalizumab), Cimzia (registered trademark) (certolizumab pegol, CDP 870), Soliris (trademark) (eculizumab), pexerizumab (anti-complement C5), Numax (registered trademark) (MEDI-524), Lucentis (registered trademark) (ranibizumab), Panorex (registered trademark) (17-1A, edrecolomab), Trabio (registered trademark) (reldelimumab), TheraCimhR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem (registered trademark) (IDM-1), OvaRex (registered trademark) (B43.13), Nuvion (registered trademark) (vizilizumab), cantuzumab meltansine (huC242-DM1), NeoRecormon (registered trademark) (epoetin beta), Neumega (registered trademark) (oprelbequin, human interleukin-11), Orthoclone OKT3 (registered trademark) (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit (registered trademark) (epoetin alfa), Remicade (registered trademark) (infliximab, anti-TNFα monoclonal antibody), Reopro (registered trademark) (absiximab, anti-GP) (Ib / Ilia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanorimumab), Rituxan® (rituximab, anti-CD20 mAb), Tarceva® (erlotinib), Roferon-A® (interferon α-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 146B7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507), Tysabri® (natalizumab, anti-α4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax®, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (Fc portion of human IgG1 and extracellular domains of both IL-1 receptor components (type I receptor and receptor co-protein)), VEGF trap (IgG1 VEGFR1 Ig domain fused with Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimabe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23mAb (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 (saltumumab), M200 (boroxiximab, anti-α5β1 integrin mAb), MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1), anti-BR3 mAb, anti-C. difficile toxin A and toxin BC mAb MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25 mAb (HuMax-TAC), anti-CD3 mAb (NI-0401), adecatumumab, anti-CD30 mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38 mAb (HuMax CD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF fibrogen for idiopathic pulmonary fibrosis stage 1 (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-1103), 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-TGFβmAb(GC-1008), TRAIL-2 mAb(HGS-ETR2), TWEAK mAb, VEGFR / Flt-1 mAb, ZP3 mAb (HuMax-ZP3)

[0035] In some embodiments, the drug delivery device may contain, or may be used with, sclerostin antibodies such as romosozumab, brosozumab, or BPS 804 (Novartis), and in other embodiments, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Examples of 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 may be used with, rilotumumab, bixalomer, trevananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the drug delivery device reservoir may be filled with IMLYGIC® (Tarimogene Laharpa Lepbec) or other oncolytic HSVs for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD;OrienX010;G207, 1716;NV1020;NV12023;NV1034; and NV1042, or the device may be used in conjunction with them. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs), including but not limited to TIMP-3. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, including 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 device of this disclosure. In addition, bispecific T cell activators with extended half-life containing an antibody Fc region (BiTE®), such as BLINCYTO® (blinatumomab), and other BiTE antibodies, not limited to those described herein, can be used in or with the drug delivery device of this disclosure. In some embodiments, the drug delivery device may contain or be used with APJ macromolecule agonists, such as but not limited to Apelin or its analogues.In some embodiments, a therapeutically effective amount of anti-thymocrine interstitial lymphocyte generating factor (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure.

[0036] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. Detailed descriptions should be interpreted as illustrative only and do not describe all possible embodiments of the Disclosure. Various alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, but such embodiments remain within the scope of the claims defining the invention disclosed herein.

[0037] Those skilled in the art will understand that various modifications, changes, and combinations of the above embodiments can be made without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes, and combinations are to be interpreted as falling within the scope of the concept of the present invention.

Claims

1. A storage system for storing drugs, A container having an internal volume for containing at least one drug, At least one passive cooling system disposed within the container, comprising at least one passive cooling system including a phase change material, An active cooling system operably coupled to the container and, when in operating mode, adapted to maintain a desired temperature within the internal volume of the container, A storage system including a storage system.

2. The storage system according to claim 1, wherein the phase-change material is transitionable between a solid state and a liquid state.

3. The storage system according to claim 2, wherein the phase change material is in a solid state before the at least one drug is placed in the internal volume of the container.

4. The storage system according to any one of claims 1 to 3, further comprising at least one drug container adapted to be placed within the internal volume of the container, wherein the at least one drug container is sized to store the at least one drug.

5. The storage system according to claim 4, wherein the at least one drug container includes a plurality of side walls, a top surface, and a bottom surface, and the at least one passive cooling system is operably coupled to at least one of the plurality of side walls, the top surface, or the bottom surface.

6. The storage system according to claim 5, wherein the at least one passive cooling system is removably disposed within an opening formed in the at least one drug container.

7. The storage system according to claim 5, wherein the at least one passive cooling system is detachably disposed within a pocket formed in the at least one drug container.

8. The storage system according to claim 7, wherein the pocket is formed on at least one of the inner surfaces of the at least one drug container or on the outer surfaces of the at least one drug container.

9. The storage system according to any one of claims 5 to 8, wherein the at least one drug container further comprises at least one expanded polystyrene member or molded polyurethane member.

10. The storage system according to any one of claims 1 to 9, wherein the at least one passive cooling system is further configured to transition to a passive cooling state that maintains a desired temperature within the internal volume of the container.

11. The storage system according to any one of claims 1 to 10, further comprising an electrical connector operably coupled to the active cooling system and supplying power to the active cooling system.

12. A method of delivering drugs, A step of placing at least one passive cooling system inside a container having internal volume, wherein the at least one passive cooling system includes a phase change material, A step of putting the drug into the internal volume of the container, The process involves connecting an active cooling system to the container, The process of transporting the aforementioned delivery container to a different location A method that includes this.

13. The method according to claim 12, wherein the phase change material is capable of transitioning between a solid state and a liquid state.

14. The method according to claim 13, wherein the phase change material is in a solid state before the at least one drug is placed in the internal volume of the container.

15. The method according to any one of claims 12 to 14, further comprising the step of cooling the container via the active cooling system before putting the drug into the container's volume.

16. The method according to any one of claims 12 to 15, further comprising the step of placing at least one drug container within the internal volume of the container, wherein the at least one drug container is sized to store the at least one drug.

17. The method according to claim 16, wherein the at least one drug container includes a plurality of side walls, a top surface, and a bottom surface, and the at least one passive cooling system is coupled to at least one of the plurality of side walls, the top surface, or the bottom surface.

18. The method according to claim 17, wherein the step of connecting the at least one passive cooling system to the at least one drug container includes detachably positioning the at least one passive cooling system within an opening formed in the at least one drug container.

19. The method according to claim 17, wherein the step of coupling the at least one passive cooling system with the at least one drug container includes detachably positioning the at least one passive cooling system in a pocket formed in the at least one drug container.

20. The method according to claim 19, wherein the pocket is formed on at least one of the inner surfaces of the at least one drug container or on at least one of the outer surfaces of the at least one drug container.

21. The method according to any one of claims 16 to 20, further comprising the step of placing at least one expanded polystyrene member or molded polyurethane member inside the at least one drug container.

22. The method according to any one of claims 16 to 21, further comprising the step of the at least one passive cooling system transitioning to a passive cooling state in which a desired temperature is maintained within the internal volume of the container.

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