DIFFERENTIATION WITHOUT DISRUPTIONIn this article, Alan Shortall, Chief Executive Officer, Unilife Corporation, describes ...
patient requirements of injectable drugs suppliedin either a liquid-stable or lyophilised form forreconstitution at the po...
generate brand differentiation for drugs mar-                                                                             ...
Once the patient attaches the device onto the                                                                             ...
Innovative Device Solutions for Drug Delivery  Introducing a diversified portfolio of innovative, differentiated systems t...
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Unilife ($UNIS) - Prefilled Syringes Issue of OnDrugDelivery

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In this article, Alan Shortall, Chief Executive Officer, Unilife Corporation, describes a new paradigm now driving the pharmaceutical market for advanced drug delivery systems, where the composition of clinical development pipelines is being increasingly dominated by complex injectable drugs, such as biologics, with specific molecular and formulation requirements that are targeted for patient self-administration. He argues that in many cases the combination of these large-molecule drugs with delivery systems comprised of commodity components sourced from conventional device manufacturers can constrain or diminish their commercialisation and marketability across highly competitive therapeutic classes. Instead, pharmaceutical companies are seeking to build long-term partnerships with a new generation of device manufacturers who specialise in the design, development and commercial supply of innovative delivery systems that can enable the commercialisation of pipeline drugs, enhance or extend product lifecycles and generate strong brand differentiation.

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  • In addition to drug delivery devices like prefilled syringes, formulation can add differentiation without distruption. Innovations in formulation technology can replace lyophilized forms with stable liquid presentations. IV liquids can be updated with high concentration protein technologies. Along with novel devices like Unifill, Lyoject and LyoTip, formulations can add to convenience, safety and efficacy.
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Unilife ($UNIS) - Prefilled Syringes Issue of OnDrugDelivery

  1. 1. DIFFERENTIATION WITHOUT DISRUPTIONIn this article, Alan Shortall, Chief Executive Officer, Unilife Corporation, describes a newparadigm now driving the pharmaceutical market for advanced drug delivery systems, wherethe composition of clinical development pipelines is being increasingly dominated by complexinjectable drugs, such as biologics, with specific molecular and formulation requirements thatare targeted for patient self-administration. He argues that in many cases the combination ofthese large-molecule drugs with delivery systems comprised of commodity components sourcedfrom conventional device manufacturers can constrain or diminish their commercialisation andmarketability across highly competitive therapeutic classes. Instead, pharmaceutical companiesare seeking to build long-term partnerships with a new generation of device manufacturers whospecialise in the design, development and commercial supply of innovative delivery systems thatcan enable the commercialisation of pipeline drugs, enhance or extend product lifecycles andgenerate strong brand differentiation.Pharmaceutical companies with access to best- fied portfolio of delivery systems, an advancedin-class delivery systems that can enhance array of operational capabilities and the flexibil-patient care, protect healthcare workers or ity to respond to the needs of the pharmaceuticalimprove therapy compliance are well posi- customer with speed, agility and reliability.tioned to succeed across therapeutic classes fac-ing heightened levels of competition amongst UNILIFE – AN EMERGING GLOBALnovel, generic or biosimilar drugs. LEADER FOR ADVANCED DRUG The development of these strong long-term DELIVERY SYSTEMSpartnerships between pharmaceutical compa-nies and device manufacturers are ultimately Unilife is a fast-growing US-based devel-focused on the development of the right device oper and commercial supplier of advanced drugto deliver the right drug to the right patient. delivery systems. In direct response to the unmetCollaborations between device manufacturers needs of pharmaceutical companies, healthcareand pharmaceutical companies can commence workers and patients, Unilife has developed oneearly during the clinical development of the of the most complete and customer-focused port- folios of injectable drug delivery devices on the market. A rich “UNLIKE CONVENTIONAL DEVICE portfolio is led by the Unifill MANUFACTURERS THAT SUPPLY range of ready-to-fill syringes Alan Shortall with integrated safety features Chief Executive Officer “ME-TOO” COMMODITY (Figure 1), and also includes T: +1 717 938 9323 patient self-administration sys- COMPONENTS, UNILIFE SERVES AS tems such as auto-injectors and Unilife Corporation A TOTAL SOLUTIONS PARTNER FOR subcutaneous pump infusion sys- 633 Lowther Road tems, as well as other specialised Lewisberry, PA 17339ADVANCED DRUG DELIVERY SYSTEMS.” devices for targeted organ deliv- USA ery. The size and scope of this T: +1 717 938 9323 F: +1 717 938 9364drug and span the entire commercial lifecycle unique portfolio, the depth of our operational E: info@unilife.comof the combination product. capabilities and our unparalleled capacity for To succeed under this new industry paradigm device innovation together enable Unilife to www.unilife.comrequires device manufacturers to have a diversi- address the specific molecular, formulation andCopyright © 2011 Frederick Furness Publishing www.ondrugdelivery.com 13
  2. 2. patient requirements of injectable drugs suppliedin either a liquid-stable or lyophilised form forreconstitution at the point of delivery. Unlike conventional device manufacturersthat supply ““me-too”” commodity components,Unilife serves as a total solutions partner foradvanced drug delivery systems. Our centre ofoperations is a state-of-the-art manufacturingfacility located in York, PA, US (Figure 2). Thismodern $32 million (£20 million) facility wasopened in late 2010 and serves as an integratedcentre for device innovation. At York, Unilife hasbrought together the people, production systems,design expertise and quality processes necessaryto design and develop best-in-class drug deliv- Figure 1: The Unifill syringe, shown here before and after use, is the first and onlyery systems targeted for use across a range of known prefilled syringe with safety features fully integrated within the glass barrel.therapeutic classes. Designed by pharmaceuticalarchitects to be ahead of the curve in the design, ilised drugs and vaccines targeted for delivery All Unifill components within the fluidproduction and supply of medical devices, the US in a prefilled format. Unifill syringes function path feature USP Class six-compliant materi-FDA-registered site plays a key role in ensuring as a primary drug container, a safety device and als sourced from established suppliers, withthat we comply with stringent internal and indus- a needle containment system all rolled into one. the devices designed for customer supply astry standards for quality and reliability. Available in both single and multiple cham- per standard handling systems for equivalent The 165,000 square-foot (15,300 m2) facility ber formats with either a staked or an attach- syringes for integration into fill-finish systems.includes 11 cleanrooms, a product development able needle, Unilife syringes feature a unique As a primary drug container with integratedcentre, quality labs, machine shops and a fully automatic needle-retraction mechanism that is safety features, Unifill syringes can streamlinesegregated warehouse. Activities undertaken atthe site include device design, rapid prototyping,pilot and commercial production, bio-analytical “UNIFILL SYRINGES ARE ALSO SIMILAR IN SIZE TO ANtesting, packaging, quality assurance and sup-ply chain. All activities at Unilife are guided by EQUIVALENT PREFILLED SYRINGE AND SIGNIFICANTLYadvanced business systems, such as SAP ERP SMALLER THAN THOSE ATTACHED WITH AN ANCILLARY(SAP AG, Walldorf, Baden-Württemberg,Germany), that complement those of our phar- SAFETY PRODUCT TO REDUCE PACKAGING, TRANSPORTmaceutical partners. Our Quality Management System is fully AND STORAGE VOLUMES BY UP TO 60-70%.”certified to ISO 13485, and in compliance with21 CRF 210/211 for pharmaceuticals and 21 activated upon full-dose delivery. With activa- pharmaceutical industrial processes and signifi-CFR 820 for medical devices. tion of the safety mechanism signaled by an cantly reduce transport, packaging and storage audible, tactile click, Unifill syringes have a true costs associated with the attachment of ancillaryUNIFILL PLATFORM OF PRIMARY end-of-dose indicator. Operators can control the safety products.DRUG CONTAINERS WITH speed at which the needle is withdrawn directlyINTEGRATED SAFETY FEATURES from the body into the barrel of the syringe. The UNIFILL SYRINGE plunger is then automatically locked to prevent We have developed a full platform of Unifill the re-use of the device, circumvent product The Unifill syringe is the world’’s first andready-to-fill syringes that are designed for use tampering, and encourage its convenient and only prefilled syringe with automatic safety fea-with a broad range of liquid-stable and lyoph- compact disposal. tures fully integrated within the glass barrel. It isFigure 2: Unilife’s Centre for Operations in York, PA, US, Designed by Pharmaceutical Architects and Purpose Built to be Ahead ofthe Curve.14 www.ondrugdelivery.com Copyright © 2011 Frederick Furness Publishing
  3. 3. generate brand differentiation for drugs mar- keted within competitive therapeutic classes to optimise product lifecycles. UNIFILL EZMIX Unifill EZMix syringes have been developed in direct response to the unmet needs of pharma- ceutical companies seeking an innovative and convenient delivery system for the reconstitu- tion and administration of lyophilised drugs and vaccines. Unifill EZmix syringes feature two or more primary drug containers within a single glass barrel to store a combination of liquidFigure 3: Unifill Select combines the benefits of automatic, fully integrated safety stable or lyophilised drugs along with up to 1mLfeatures with the ability to attach interchangeable needles. of diluent for reconstitution. In addition to being the world’’s first and onlyprimarily designed for use with injectable drugs The Unifill syringe is now in initial produc- known dual or multi-chamber prefilled syringesand vaccines between 0.2 mL and 1.0 mL in vol- tion at our production facility in York, and with automatic (passive) safety features fully inte-ume and indicated for subcutaneous injection. It available for supply to pharmaceutical custom- grated within the glass barrel, the Unifill EZMixis currently available with a staked (fixed) ½”” ers for compatibility and stability testing. syringe offers minimal steps of use for healthcareneedle in either a 27- or 29-gauge format. workers and patients alike. The operator simply The Unifill syringe is supplied to pharma- UNIFILL SELECT advances the plunger to mix the lyophilisedceutical manufacturers as per standard handling powder with the diluent, before swirling theprocesses, and designed for integration into the The Unifill Select range of ready-to-fill device to complete reconstitution. An audible,fill-finish systems used for equivalent conven- syringes combines the benefits of automatic, tactile click signals the injection of the full dosetional ready-to-fill syringes. The Unifill syringe fully integrated safety features with the ability and the activation of a passive safety system thatcan eliminate the current requirement to purchase to attach interchangeable needles of up to 1½”” allows operators to control the speed of needleseparately and attach ancillary safety products in length (see Figure 3). Unifill Select syringes retraction directly from the body into the barrel.onto a standard prefilled syringe after dose filling facilitate the use of injectable drugs and vac- The Unifill EZMix syringe has been designed forand prior to packaging. Unifill syringes are also cines between 0.2 and 1.5 mL in volume that development in either a fixed (staked) needle forsimilar in size to an equivalent prefilled syringe are supplied in either a liquid-stable form or drugs indicated for sc injection, or with attachableand significantly smaller than those attached with lyophilised for reconstitution. needles of up to 1.5 inches (3.8 cm) in length.an ancillary safety product to reduce packaging, Unifill Select delivery systems are sup-transport and storage volumes by up to 60-70%. plied as per standard handling systems for UNIFILL AUTO-INJECTORS The combination of automatic, operator- integration into fill-finish systems used forcontrolled retraction features within the Unifill equivalent conventional 1mL standard, 1mL The Unifill range of auto-injectors hassyringe helps to virtually eliminate the risk of long or larger prefilled syringes. As primary been designed for the accurate, intuitive andinfection from needlestick injuries or other poten- drug containers with USP Class six-compliant convenient administration of injectable drugstial transmission modes including aerosolisation materials within the drug fluid path, Unifill by patients outside of healthcare facilities.(splatter). Independent evaluations of the Unifill Select products are similar in size to equiva- Developed for use in conjunction with Unifillsyringe comparing it with leading prefilled lent prefilled syringes. Select products may prefilled syringes, Unifill Auto-Injectors aresyringes supplied with ancillary safety devices be supplied ready-for-injection in a kit format extremely compact, and enable patients to injectfound experienced healthcare workers strongly with one or more needles for intuitive and a measured dose of medication with the simplepreferred it across all surveyed areas including convenient administration either directly to push of a button. Unlike conventional auto-safety, ease-of-use, handling and intuitiveness. the patient or via an iv port. injector technologies that are used with stand- ard prefilled syringes, the incorporation of the Unifill syringe with its integrated safety features “UNIFILL EZMIX SYRINGES FEATURE TWO OR MORE PRIMARY give Unifill Auto-Injectors several significant market advantages including a relatively small DRUG CONTAINERS WITHIN A SINGLE GLASS BARREL.” diameter and a true end-of-dose indicator. Unifill Auto-Injectors are being developed in The safety and functionality benefits of the In addition to its targeted use with drugs sup- a range of single-use disposable and re-usableUnifill syringe and its unique ergonomic styling plied in a liquid-stable format, the Unifill Select configurations for use across a wide spectrumto prefilled devices can be utilised by pharma- can also be prefilled with a diluent and pack- of therapeutic drug classes. The devices can beceutical companies to extend product lifecycles, aged with a vial adaptor for use with lyophilised custom-designed to support a range of drug vis-increase levels of market differentiation in com- drugs requiring reconstitution. As a unique cosities and patient dexterity requirements. Withpetitive therapeutic areas, and expand the market- delivery system for liquid-stable drugs targeted the increasing standardisation of many injectableability of drugs for convenient self-administra- for im injection, or other lyophilised drugs, drugs across a number of therapeutic classes intion by patients outside of the healthcare setting. Unifill Select syringes are ideally positioned to both a stand-alone prefilled syringe format andCopyright © 2011 Frederick Furness Publishing www.ondrugdelivery.com 15
  4. 4. Once the patient attaches the device onto the injection site and pushes the activation button, the automatic infusion of the drug into the subcutane- ous tissue commences. With the size, shape and functionality of the AutoInfusor being ergonomi- cally designed for optimal wearability, the patient can continue to go about their normal daily routines during the period of dose delivery. A series of audible, tactile and visual indicators can signal to the patient when the full dose has been delivered, at which time the AutoInfusor can be removed from the body for convenient disposal. NOVEL DEVICES FOR TARGETED ORGAN DELIVERY We work with pharmaceutical companies to develop specialised drug delivery systems to administer biologics and other macromolecular drugs that require high-precision administrationFigure 4: AutoInfusors are now available for human clinical trials in either prefilled to target organs of the human body. For theseor fill-at-time-of-use formats. projects, we collaborate directly with our pharma-supplied with an auto-injector, the combination panies with drugs that have complex formulations ceutical customers early in the development phaseof the Unifill syringe and a compact, accurate with higher viscosities and requiring large dose to identify and address the specific molecular andauto-injector under one best-in-class technology volumes. AutoInfusors are now available for sup- patient requirements of a target pipeline drug.platform can streamline the pathway to com- ply to pharmaceutical companies for human clini- By addressing the specific device innova- tion needs of our pharmaceutical customers in parallel with the development of the target “ONCE THE PATIENT ATTACHES THE DEVICE ONTO THE pipeline drug, the specialised organ delivery INJECTION SITE AND PUSHES THE ACTIVATION BUTTON, systems that we deliver to our pharmaceutical customers can help to support successful clini- THE AUTOMATIC INFUSION OF THE DRUG INTO THE cal trial outcomes and the filing of regulatory applications with strong claims for the com- SUBCUTANEOUS TISSUE COMMENCES.” bination product. In addition, our proprietary organ delivery systems can help to generatemercial launch and generate powerful brand dif- cal trials in either prefilled or fill-at-time-of-use strong brand differentiation for the target drug,ferentiation during the product lifecycle. formats. AutoInfusors are compact, single-use and potentially obstruct the entry of other drug delivery systems that are designed for brand-name, biosimilar or generic competitors.AUTOINFUSORS simple, intuitive and convenient use by patients With Unilife, pharmaceutical and biotech- outside of healthcare facilities. Consisting of a nology companies now have the option of We have developed a proprietary range of sin- primary drug container, fluid delivery path, and selecting a single partner in the developmentgle-use, disposable subcutaneous infusion pump drive mechanism, AutoInfusors are modular in and commercial supply of innovative, differen-systems for the patient self-injection of drugs design and can be customised to address the tiated devices that can help to enable, enhancebetween 3 mL and 10 mL in volume. specific requirement of the drug and its target and extend the commercial lifecycles of their Unilife has developed its AutoInfusor technol- patient. They can be pre-set for infusion periods injectable drugs and vaccines.ogy (shown in Figure 4) to address the unmet that can span minutes or hours in duration, as Pharmaceutical customers are encouraged toneeds of pharmaceutical and biotechnology com- specified by the pharmaceutical customer. contact Unilife at info@unilife.com. IN WHICH EDITION SHOULD YOUR COMPANY APPEAR? WWW.ONDRUGDELIVERY.COM16 www.ondrugdelivery.com Copyright © 2011 Frederick Furness Publishing
  5. 5. Innovative Device Solutions for Drug Delivery Introducing a diversified portfolio of innovative, differentiated systems to help enable, enhance and extend the lifecycles of liquid stable and lyophilized drugs Proprietary technology platforms include primary drug containers with integrated safety features, patient-self-injection systems such as auto-injectors andlarge-volume subcutaneous infusion systems, and novel devices for organ delivery See us at CPHI, Frankfurt (Oct 25-27 Booth 41G32), AAPS, Washington D.C (Oct 24-26 Booth 908) and PDA, Basel (Nov 7-11 Booth 25) www.unilife.com info@unilife.com

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