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Pharmaceutical & Medical Packaging News, November/December 2015

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pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2015 20 Contract & Clinical Trial Packaging Demands on Pharma Are Changing—and So Is the Packaging Support With patient needs changing and pharmaceutical supply chains evolving, pharmaceutical manufacturers face numerous challenges. One contract packager explains how it, too, is evolving to provide the necessary support. P harmaceutical manufactur- ers are navigating a changing marketplace. There's greater variety in drug-delivery for- mats to support new formula- tions, new modes of dosing, and new users—in many cases the patients them- selves. There's also greater demand for item identification and tracking to sup- port more-complex supply chains. PMP News asked Jeff Benedict, Senior Vice President, Global Business Development, Sharp Packaging Solutions, to weigh in on these changes, the challenges they present, and some potential solutions. PMP: Can you describe some of the specific challenges the pharmaceutical industry is currently facing? Benedict: As the pharmaceutical industry continues to evolve in the types of drug and biologic therapies it devel- ops and where it delivers these products, we believe it is facing many challenges. There is the rising complexity of sup- ply chains due to the diversity of drug- delivery mechanisms and the industry's global footprint, an escalating increase in counterfeiting and diversion, and the con- tinuous evolution and reengineering of companies as a result of the many merg- ers and acquisitions. Also, the new drugs being developed to meet new therapeutic categories often dictate new drug technol- ogies, delivering these medications in dif- ferent formats depending on the patient. This development sets up a whole new way of looking at drug delivery and its related package. Along with this, comes the challenge of identifying these products throughout the delivery chain and estab- lishing the right IT infrastructure to cap- ture the product data, store it, integrate it, and then share it where appropriate. PMP: How are requests for drug- delivery and packaging evolving, and how can Sharp help? Benedict: Sharp has been following closely the diferent formats of drugs in the industry. We have tremendous capac- ity in the United States and Europe to handle standard typical oral dose prod- ucts requiring blisters and bottles, but we can also support, in both our Allentown and Netherlands packaging facilities, the high cost and highly divertible Schedule II drugs, distribution of which is pretty much controlled by the DEA. In addition, we have made significant investments to expand our equipment platforms to support the ever-evolving drug-delivery challenges. Drug-delivery systems and packaging evolutions have evolved massively from oral tablets, a syringe, or a transdermal patch, to many diferent formats of delivery systems from the buccal and the oral thin-film dissolv- able applications to single-unit syringes with a safety needle where the patient does the dose in the hospital or at home. As a result, our packaging lines have evolved to handle projects such as micro- dose powder filling into cartridges and diferent biologic applications for specific therapeutic categories such as vials and autoinjector pens. For these biologics, we don't do sterile fill, but we do label, carton, kit, and serialize. For instance, we would take a vial, label it, put it in a kit with multiple syringes and diferent type of literature that might be patient required, serialize at all levels, carton it, and cold-chain ship. Oral thin-film is another evolving drug-delivery mechanism. We currently have two lines in Allentown where we take the finished drug in a reel format and cut it, print on it, and package it. We will also have this capability in the Neth- erlands in 2016. We made the decision to invest in the specific pieces of equip- ment that support this drug-delivery Blister packaging operations. Image courtesy Sharp Packaging Solutions

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