Patent Description:
Drugs are administered to treat a variety of conditions and diseases. These drug dosings may be performed in a healthcare facility, or in some instances, at remote locations such as a patient's home. In certain applications, a drug product may be shipped to a healthcare facility (e.g., an inpatient facility, an outpatient facility, and/or a pharmacy) in a powdered or lyophilized form or alternatively in a liquid form.

When reconstituting these drugs for administration, it is desirable to maintain a clean and/or sterile environment so as to not taint or otherwise damage the quality of the drug or otherwise impact development. Additionally, some classes of drugs such as bi-specific T-cell engagers may require exceptionally accurate quantities of the drug product and/or other fluids required for dosing. Oftentimes, the healthcare professional must prepare the drug by closely following a set of steps to ensure a sterile environment is maintained and that correct quantities of ingredients are added to the delivery container. As a result, the reconstitution process may be time-consuming, tedious, and may have an unacceptable or undesirable error rate. Development of robotic based analytical workflows for lyophilized drug products has resulted in a reduction of time and labor intensive sample preparation tasks in addition to the mitigation of safety concerns such as exposure to needles during drug reconstitution. These new workflows may reconstitute lyophilized samples autonomously or semi-autonomously, extract the samples from sealed containers, and/or perform sample preparation steps such as dispensing samples into a microwell plate for measuring protein concentrations, each with minimal or no manual intervention.

In some existing approaches, a needle assembly may be provided that includes a piercing needle and a separate venting needle. Due in part to the thickness of the seal of the drug product vial, such an arrangement could result in one or both of the piercing and venting needles becoming damaged or otherwise broken during insertion. Further, in these systems, one or both of the needles could become stuck in the seal, and as a result, upon raising the needle assembly, the seal and/or the drug product vial may remain coupled with the needle or needles, causing the drug product vial to be lifted out of its storage rack. As such, these existing systems oftentimes require manually removing the drug product vial from the needle or needles, and may lead to potential sources of contamination.

As described in more detail below, the present disclosure sets forth systems and methods for using a robotic-based reconstitution system embodying advantageous alternatives to existing systems and methods, and that may address one or more of the challenges or needs mentioned herein, as well as provide other benefits and advantages.

<CIT> discloses apparatuses and methods for creating and testing pre-formulations and systems for same. <CIT> discloses a needle assembly. <CIT> discloses a method for characterizing polymorphs.

In accordance with a first aspect, a drug reconstitution system includes a robotic arm movable between a plurality of positions, at least one bracket member operably coupled with the robotic arm, and at least one coaxial needle operably coupled with the robotic arm. The at least one bracket member includes a mounting region, a support surface, an upper surface, and a throughbore extending through the support surface and the upper surface. The at least one coaxial needle is movably disposed between the throughbore of the at least one bracket member. The at least one coaxial needle is adapted to pierce at least a portion of a vial and dispense a liquid into the vial during drug reconstitution.

In some examples, the at least one coaxial needle includes a proximal end, a distal end, an elongated length extending therebetween, a piercing tip positioned at the proximal end, a dispensing opening positioned at or near the proximal end, and a first venting hole positioned along the elongated length. The piercing tip and the dispensing opening of the at least one coaxial needle may be disposed on an inner member, and the first venting hole may be disposed on an outer member. The outer member may be at least partially hollow to receive at least a portion of the inner member. In some examples, a second venting hole may be provided that is disposed on the outer member distally from the first venting hole. The first venting hole and the second venting hole may cooperate to create a venting path to an external environment.

In some examples, the support surface of the at least one bracket member is adapted to engage a contact face of a drug vial during at least one of drug aspiration or drug reconstitution via movement of the robotic arm to a lowered position. Further, in some examples, the at least one coaxial needle may be movable relative to the at least one bracket member such that the at least one coaxial needle may be selectively raised while the support surface of the at least one bracket member remains engaged with the contact face of the drug vial. In some examples, an urging member may be provided to exert an urging force on the at least one bracket member.

In some approaches, the drug reconstitution system may include a needle assembly operably coupled with the robotic arm, the at least one bracket member, and the at least one coaxial needle. The needle assembly may include a liquid reservoir to dispense into the at least one coaxial needle.

In accordance with a second aspect, an approach for reconstituting a drug via a robotic arm movable between a plurality of positions includes operably coupling at least one bracket member with the robotic arm and operably coupling at least one coaxial needle with the robotic arm. The at least one coaxial needle is fluidly coupled with a reconstituting fluid. The robotic arm is lowered to a lowered position whereby the at least one bracket member and the at least one coaxial needle move to a lowered position adjacent to a drug vial. The approach further includes reconstituting the drug by causing the reconstituting fluid to flow through at least a portion of the at least one coaxial needle. The at least one coaxial needle is raised to a raised position while the at least one bracket member remains adjacent to the drug vial. The at least one bracket member is raised to a raised position.

In some approaches, the drug reconstitution system includes a drug product vial containing a drug product, a robotic arm adapted to move between a plurality of positions, at least one bracket member operably coupled with the robotic arm, and at least one coaxial needle operably coupled with the robotic arm. The drug product vial includes a seal member to retain the drug product within the drug product vial. The at least one bracket member includes a mounting region, a support surface, an upper surface, and a throughbore extending through the support surface and the upper surface. The at least one coaxial needle is at least partially disposed between the throughbore of the at least one bracket member and movable relative thereto. The at least one coaxial needle includes a first end, a second end operably coupled with the robotic arm, an outer member, an inner member at least partially disposed within the outer member, a piercing tip positioned at the first end, and at least one venting hole disposed on the outer member. Upon moving the robotic arm to a lowered position, the piercing tip of the at least one coaxial needle is adapted to pierce at least a portion of the seal member of the drug product vial and the support surface of the at least one bracket member is adapted to be positioned adjacent to the seal member of the drug product vial.

The above needs are at least partially met through provision of the coaxial needle adapter and guide bracket for the robotic liquid handling platform described in the following detailed description, particularly when studied in conjunction with the drawings, wherein:.

For example, the dimensions and/or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments. It will further be appreciated that certain actions and/or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. It will also be understood that the terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein.

Generally speaking, pursuant to these various embodiments, an adapter bracket and coaxial needle are provided. The adapter bracket acts as a guide and a support for the coaxial needle, which is used to reconstitute lyophilized drug product such as, for example, a bispecific T cell engager (BiTE) in an automated workflow. The coaxial needle and adapter bracket are each mounted to a robotic arm, and more specifically, a needle assembly or liquid handling platform thereof, which in some examples may be a part of a larger automated liquid handling platform.

Turning to the figures, pursuant to these various embodiments, a drug reconstitution system <NUM> is provided that includes a robotic arm <NUM>, a holder <NUM> that accommodates a number of drug vials <NUM>, any number of bracket members <NUM>, and any number of coaxial needles <NUM>. It is appreciated that the drug reconstitution system <NUM> provided herein is but one example of such a system. The drug reconstitution system <NUM> may reconstitute, extract, and/or process a large number (e.g., approximately <NUM>) of drug vials <NUM> every minute, and in some examples, can actively perform chemical analyses such as ascertaining sample protein concentrations at a similarly high rate.

The robotic arm <NUM> is movable between a number of positions within the confines of a three-dimensional area such as, for example, a raised position that is spatially removed from the holder <NUM> and/or drug vials <NUM>, and a lowered position that is adjacent to the holder <NUM> and/or the drug vials <NUM>. In some examples, a needle assembly (or liquid handling platform) <NUM> may be operably coupled with an end of the robotic arm <NUM> to reconstitute and/or otherwise prepare the drug vials <NUM> for use. In some examples, the needle assembly <NUM> may be fluidly coupled with a fluid reservoir <NUM> that may include a fluid such as a reconstituting fluid (e.g., a diluent) to be used during reconstitution. As a non-limiting example, any number of fluid lines <NUM> may extend from the fluid reservoir <NUM> to the needle assembly <NUM>. The fluid reservoir <NUM> may include a pumping mechanism (not illustrated) to urge specific quantities of the reconstituting fluid to the needle assembly <NUM> as desired. The robotic arm <NUM> may include any number of mechanical and electromechanical components, sub-components, systems, power sources, measuring devices, processors, controllers, and the like to operate in an autonomous or semi-autonomous manner.

The drug vial <NUM> may be in the form of a prefilled container and includes a vial body defining an inner volume <NUM> and a vial seal or stopper <NUM>. In some examples, the drug vial <NUM> may also include a vial adapter <NUM> used to releasably couple with other components (e.g., a drug delivery container, a syringe, a drug delivery device, etc.). The inner volume <NUM> may be sterile. In some approaches, the vial seal <NUM> may be in the form of a rubber stopper having a thickness of approximately <NUM>. Other examples are possible. The vial seal <NUM> includes a contact surface 113a positioned on an upper side thereof that, in some examples, may be exposed to an external environment <NUM> (i.e., an environment outside of the inner volume <NUM>). Further, in some examples, the vial adapter <NUM> may also be a CSTD that mates, engages, and/or couples to other adapters such as, for example, a delivery container adapter (not illustrated).

The inner volume <NUM> of the drug vial <NUM> contains a predetermined quantity of drug product or active pharmaceutical ingredient ("API") <NUM> (e.g., between approximately <NUM> mcg and approximately <NUM> mcg), depending on the BiTE and vial size, which, in the illustrated example, is in powdered form (i.e., lyophilized) requiring reconstitution. In other examples, the drug product <NUM> may be in liquid form and may not require reconstitution. Nonetheless, the system <NUM> includes an accurate quantity of drug product <NUM>, and thus does not require the need to add additional quantities thereto in a sterile environment.

In some examples, the API may be in the form of a half-life extended ("HLE") BiTE and/or an IV-admin monoclonal antibody ("mAbs") as desired. These HLE BiTEs include an antibody Fc region that advantageously provides different drug properties such as longer and extended half-lives. Accordingly, such APIs may be preferred due to their ability to maintain protective levels in the patient for relatively longer periods of time. Nonetheless, in other examples, the API may be in the form of a canonical-BiTE that is to be administered in a professional healthcare environment.

As previously noted, the fluid reservoir may contain and/or dispense a predetermined quantity of reconstituting fluid <NUM> or diluent (e.g., preservative-free water for injection or "WFI"; between approximately <NUM> and approximately <NUM>) to be added to the prefilled drug vial <NUM> for reconstitution of the drug product <NUM>. In some examples, a benzyl alcohol preserved (or any other preservative) WFI may be used.

The bracket member <NUM> is operably coupled with the robotic arm <NUM>. More specifically, the bracket member <NUM> includes a mounting region <NUM> in the form of a recessed area having any number of mounting holes 122a. The bracket member <NUM> is operably coupled with the needle assembly <NUM> by aligning a mounting plate <NUM> of the needle assembly <NUM> with the corresponding mounting region <NUM> and coupling the two members together via a fastener or fasteners (see, e.g., <FIG>). Other mounting approaches are possible such as, for example, a friction fit coupling, a snap coupling, and the like. Any number of bracket members <NUM> may be operably coupled with the needle assembly <NUM> via respective mounting plates <NUM>.

The bracket member <NUM> further includes a lower or support surface <NUM>, an upper surface <NUM>, a throughbore <NUM> extending between the support surface <NUM> and the upper surface <NUM>. Further, the bracket member <NUM> may include a rod mounting portion <NUM> in the form of a hole and a bore <NUM> to receive a set screw (not illustrated) used to retain a rod <NUM> (<FIG>) therein. A resilient member <NUM> in the form of a spring may be coupled with and/or surround the rod <NUM>.

With brief reference to <FIG>, an alternative bracket member <NUM> is provided that includes similar features as the bracket member <NUM>, but includes a relatively higher support surface <NUM> than the support surface <NUM> of the bracket member <NUM>.

The coaxial needle <NUM> includes a first or proximal end 130a, second or distal end 130b operably coupled with the robotic arm <NUM> (e.g., via a portion of the needle assembly <NUM>), an elongated length 130c, an inner member <NUM>, and an outer member or sheath <NUM>. In some examples, the inner member <NUM> may be a <NUM> GA needle, and the outer member <NUM> may be <NUM> GA. Other examples are possible. As illustrated in <FIG>, the outer member <NUM> does not extend fully to the proximal end 130a and instead terminates along a portion of the elongated length 130c. However, other arrangements are possible. Positioned at the proximal end 130a is a piercing tip <NUM> used to pierce at least a portion of the vial seal <NUM>. Further, a dispensing opening <NUM> is also positioned at or near the proximal end 130a. The inner member <NUM> may be hollow and in fluid communication with the fluid reservoir <NUM> via the fluid line <NUM>. More specifically, in some examples, the inner member <NUM> and/or the outer member <NUM> may be coupled with a port (not illustrated) of the needle assembly <NUM> via a threaded coupling to create a fluid path from the needle assembly <NUM> to the dispensing opening <NUM>. In some examples, the coaxial needle <NUM> may include a male threaded region at the distal end 130b that insertably couples with a female threaded region on the needle assembly. Such a coupling eliminates a need for a set screw to retain the coaxial needle <NUM>.

The outer member <NUM> is also at least partially hollow, and surrounds at least a portion of the inner member <NUM>. The outer member <NUM> includes a number of vent holes <NUM> along the elongated length 130c. In some examples, the upper end of outer member <NUM> may be open to the external environment <NUM>, and in other examples, the upper end of the outer member <NUM> may be closed and/or abut against a portion of the needle assembly <NUM>. In the illustrated examples, a second venting hole <NUM> is positioned above or distal to the first venting hole <NUM>. The second venting hole <NUM> may be positioned at any number of locations at or near the second end 130b of needle. The distance between the venting holes <NUM> may be defined relative to the dimensions of the drug vial <NUM> such that upon inserting the coaxial needle <NUM> into the inner volume <NUM> thereof, one venting hole <NUM> is positioned inside the inner volume <NUM> (i.e., below the vial seal <NUM>), and one venting hole <NUM> is positioned outside the drug vial <NUM> (i.e., exposed to the external environment <NUM>). Further, the first or lower vent hole <NUM> is positioned at a specified length such that it is higher than the fill level in the drug vial <NUM> under any circumstances (even after drug reconstitution).

The coaxial needle <NUM> may also include a chamfered or tapered region <NUM> positioned at the end of the outer member <NUM> to allow for a gradual transition in the varying outer diameter of the inner member <NUM> and the outer member <NUM>. Such a chamfered region <NUM> may allow for the coaxial needle <NUM> to more smoothly penetrate the vial seal <NUM>. When both the coaxial needle <NUM> and the bracket member <NUM> are coupled with the needle assembly <NUM>, the coaxial needle <NUM> is disposed at least partially through the throughbore <NUM>. As such, the throughbore <NUM> acts as a guide to limit movement of the coaxial needle <NUM>. The coaxial needle <NUM> is movable relative to the bracket member <NUM>. As with the bracket member <NUM>, any number of coaxial needles <NUM> may be used and coupled with the robotic arm <NUM> to perform multiple operations concurrently.

To initiate drug reconstitution, the robotic arm <NUM> moves from an initial position in which the coaxial needle <NUM> is spaced away from the drug vial <NUM> to a raised position located axially above the drug vial <NUM>. It is noted that in some examples, the robotic arm <NUM> may already be positioned above the drug vial <NUM> so the initial movement may not be necessary. The robotic arm <NUM> may lower to a lowered position which causes the piercing tip <NUM> of the coaxial needle <NUM> to pierce at least a portion of the vial seal <NUM>. With reference to <FIG>, upon piercing the vial seal <NUM>, the first end 130a of the coaxial needle <NUM> is positioned within the inner volume <NUM> of the drug vial <NUM>. More specifically, both the dispensing opening <NUM> and the lower venting hole <NUM> are positioned within the inner volume of the drug vial <NUM>.

The system <NUM> initiates drug reconstitution by adding (automatically, in some examples) a predetermined quantity of reconstituting fluid <NUM> from the fluid reservoir <NUM> through the fluid lines <NUM>, to the needle assembly <NUM>, through the second end 130b of the coaxial needle <NUM> (i.e., through the inner member <NUM>), to the first end 130a of the coaxial needle <NUM> and out the dispensing opening <NUM>. The process of reconstitution may generate a gas as the reconstituting fluid <NUM> is added to the drug vial <NUM>, and as illustrated in <FIG>, the gas may enter the lower venting hole <NUM>, travel through the inside of the outer member <NUM> (while remaining separate from the fluid <NUM> traveling through the inner member <NUM>), and out the second venting hole <NUM>. Accordingly, the coaxial needle <NUM> may vent the pressure generated by reconstitution to reduce a risk of over pressurization.

Additionally, when the robotic arm <NUM> lowers, the bracket member <NUM> also lowers relative to the drug vial <NUM>. The support surface <NUM> of the bracket member <NUM> may either rest on an upper surface 113b of the vial seal <NUM> or near (e.g., within approximately <NUM>) the upper surface 113b of the vial seal <NUM>. In some examples, the resilient member <NUM> may urge the bracket member <NUM> downwardly and against the vial seal <NUM>. As such, the bracket member <NUM> (i.e., the throughbore <NUM>) not only guides movement of the coaxial needle <NUM>, but also assists in retaining the vial <NUM> within the holder <NUM> by limiting the ability of the drug vial <NUM> to move axially out of the holder <NUM>.

Upon completion of reconstitution, the robotic arm <NUM> may raise to a raised position relative to the drug vial <NUM>. This movement may then cause the coaxial needle <NUM> to be moved upwardly from the drug vial <NUM>. The bracket member <NUM> remains in the lowered position, and as such, the support surface <NUM> of the bracket member <NUM> may retain the drug vial <NUM> within the holder <NUM> to allow the coaxial needle <NUM> to be retracted from the vial seal <NUM>. In some examples, the resilient member <NUM> may urge the bracket member <NUM> against the vial seal <NUM> to exert an opposing force on the drug vial <NUM> that opposes the retracting force from the coaxial needle <NUM> being retracted from the drug vial <NUM>. Upon the coaxial needle <NUM> being removed, bracket member <NUM> may then be raised to allow for additional processing as needed. In some examples, the spring-loaded support rod <NUM> holds down the vial <NUM> as the robotic arm <NUM> retracts the coaxial needle <NUM> from the vial <NUM>. In some examples, the support surface <NUM> of the bracket member <NUM> is flush with the piercing tip <NUM> of the coaxial needle <NUM> such that when the arm <NUM> is fully raised, the bracket member <NUM> is retracted from the top of the vial <NUM>. Notably, the drug vial <NUM> remains in the holder <NUM> during the entire reconstitution process.

In some examples (not illustrated), the robotic arm <NUM> may include a first movable member that causes the coaxial needle <NUM> to move and a second movable member that causes the bracket member <NUM> to move. In these examples, the first and second movable members may be separately actuatable such that the coaxial needle <NUM> and the bracket member <NUM> may move together initially to be positioned at or near the drug vial <NUM>, and subsequently, the first movable member may be moved separately to retract the coaxial needle <NUM>.

With reference to <FIG>, the system <NUM> may also be used to aspirate or draw the drug product <NUM> from the drug vial <NUM>. In this example, the needle assembly <NUM> may include a pumping mechanism capable of drawing the drug product <NUM> from the drug vial <NUM>. To avoid a vacuum from forming within the drug vial <NUM>, air enters the upper vent hole <NUM> and enters the inner volume <NUM> of the drug vial <NUM> via the lower vent hole <NUM>.

Upon reconstituting the drug product <NUM>, further operations may occur such as, for example, gently stirring, swirling, and/or inverting the drug vial <NUM>, thereby forming a mixed drug product. The reconstituted drug container <NUM> may then be visually inspected for imperfections and/or to ensure adequate mixing has occurred. The reconstituted drug contained in the prefilled drug vial <NUM> may then be transferred into any number of containers (e.g., a drug delivery container (not illustrated) by mating the vial adapter <NUM> of the prefilled drug vial <NUM> to a corresponding delivery container adapter. So configured, this system may quickly perform the step of reconstitution (thus greatly reducing preparation times) and safely. The systems described herein avoid and/or eliminate the potential occurrence of needle sticking and/or spills due to over-pressurizing of the vial. Additionally, contamination is mitigated via the venting holes.

It will be appreciated that the systems and approaches described herein may be used for the storage and transport of drugs in various states, such as but not limited to drug products which have undergone completion of mixing and/or other finishing steps, drug substances which are intended to be mixed and/or finished after shipping, components or ingredients to be used in a drug, or other drug-related states or components.

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

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

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

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

Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-<NUM> receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-<NUM> and/or IL-<NUM> to the receptor; Interleukin <NUM>-receptor <NUM> ("IL1-R1") specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, a dimer of a human-mouse monoclonal hLL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, <NPL>; IGF-<NUM> receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti-IGF-1R antibodies; B-<NUM> related protein <NUM> specific antibodies, peptibodies, related proteins and the like ("B7RP-<NUM>" and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-<NUM>, including but not limited to those that inhibit the interaction of B7RP-<NUM> with its natural receptor, ICOS, on activated T cells; IL-<NUM> specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-<NUM> antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-<NUM> specific antibodies, peptibodies, related proteins, and the like, and other TALL specific binding proteins; Parathyroid hormone ("PTH") specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, related proteins, and the like;Hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF/SF:cMet axis (HGF/SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor/scatter (HGF/SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and/or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and/or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) Erythropoietin [<NUM>-asparagine, <NUM>-threonine, <NUM>-valine, <NUM>-asparagine, <NUM>-threonine], Darbepoetin alfa, novel erythropoiesis stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-<NUM>, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-?4ß7 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-<NUM>); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2/neu (erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar to Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancers; Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand, Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-<NUM>); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP <NUM>); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-<NUM>); Lucentis® (ranibizumab); Panorex® (<NUM>-1A, edrecolomab); Trabio® (Ierdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-<NUM>); OvaRex® (B43. <NUM>); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-<NUM>); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNF? monoclonal antibody); Reopro® (abciximab, anti-GP Ilb/llia receptor monoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); MvasiTM (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see <CIT>); Tysabri® (natalizumab, anti-?4integrin mAb); Valortim® (MDX-<NUM>, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-<NUM> trap (the Fc portion of human IgG1 and the extracellular domains of both IL-<NUM> receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to IgG1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2R? 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 <NUM> (golimumab, anti-TNF? mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor-<NUM> mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-?<NUM>?<NUM> integrin mAb); MDX-<NUM> (ipilimumab, anti-CTLA-<NUM> mAb and VEGFR-<NUM> (IMC-18F1); anti-BR3 mAb; anti-C. difficile Toxin A and Toxin B C mAbs MDX-<NUM> (CDA-<NUM>) and MDX-<NUM>); anti-CD22 dsFv-PE38 conjugates (CAT-<NUM> and CAT-<NUM>); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-<NUM>); adecatumumab; anti-CD30 mAb (MDX-<NUM>); MDX-<NUM> (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-<NUM>); anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-<NUM>); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-<NUM> human mAb (MYO-<NUM>); anti-GM-CSF Receptor mAb (CAM-<NUM>); anti-HepC mAb (HuMax HepC); anti-IFN? mAb (MEDI-<NUM>, MDX-<NUM>); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-<NUM>); anti-IL12/IL23 mAb (CNTO <NUM>); anti-IL13 mAb (CAT-<NUM>); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptors mAb (MDX-<NUM>, CNTO <NUM>); anti-IP10 Ulcerative Colitis mAb (MDX-<NUM>); BMS-<NUM>; anti-Mannose Receptor/hCG? mAb (MDX-<NUM>); anti-mesothelin dsFv-PE38 conjugate (CAT-<NUM>); anti-PD1mAb (MDX-<NUM> (ONO-<NUM>)); anti-PDGFR? antibody (IMC-3G3); anti-TGFß mAb (GC-<NUM>); anti-TRAIL Receptor-<NUM> human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR/Flt-<NUM> mAb; and anti-ZP3 mAb (HuMax-ZP3).

Claim 1:
A drug reconstitution system (<NUM>) comprising:
a robotic arm (<NUM>) movable between a plurality of positions;
at least one bracket member (<NUM>) operably coupled with the robotic arm, the at least one bracket member including a mounting region (<NUM>), a support surface (<NUM>), an upper surface, and a throughbore extending through the support surface and the upper surface; and
at least one coaxial needle (<NUM>) operably coupled with the robotic arm and being movably disposed between the throughbore of the at least one bracket member, wherein the at least one coaxial needle is adapted to pierce at least a portion of a vial and dispense a liquid into the vial during drug reconstitution.