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Pharmaceutical & Medical Packaging News, November/December 2015

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21 November/December 2015 Pharmaceutical & Medical Packaging News • pmpnews.com mechanism because it represented a growing need in patient care for a quick- er disintegration of the drug into the blood stream for those who can't take oral medication or for conditions that might need a rapid dissolve. In the Unit- ed States, we have one stability format line where we can do small runs, and then a larger line where we can dose and pouch commercial run batches. In the EU, we will have a full Harro Hoflinger line by late summer 2016 to support mul- tiple customer applications for oral thin- film and dissolvable-type products. Likewise, personalized medicine deliv- ery is growing in therapeutic categories like diabetes or CNS conditions or for life- saving-type drugs. To meet these packag- ing needs, we have invested in secondary equipment with multiple lines in the Unit- ed States and Europe that can take sterile- filled cartridges and do the assemblies of the injectable pens, label them, and kit them. However, we can take this a step beyond to meet late-phase customization needs cost efectively. For example, we can make a naked or unlabeled pen on a large-scale piece of equipment in the United States and then cold chain ship to our facility in Belgium, where we store the pens until QP release for the European theater, label, package, and finalize them in small lots for distribution. Working with our clinical sister divi- sion also keeps us aware of drug-delivery changes, and we are called upon at times to support their customers' requests for packaging applications that they could not label or pouch fill. We may start with a small Phase II project, establish a com- fort level and meet audit requirements, and then assist that customer with full commercialization—truly beginning-to- end support. Along the same lines, we have cre- ated an orphan drug cell in the United States as the culmination of a few clients looking for rapid-to-market release of product. Recognizing the importance of this need for the industry, we devised a way to work with these customers to establish a line and get it validated in advance so that order fulfillment can be immediate. Once we have a validated line, we are ready to go at a moment's notice. So when a patient goes into a clinic and gets a script for one of these orphan drugs, the total turnaround from us to patient is three to five days. We can do this because we have the production and cold-storage capacity that might not be available internally to the pharmaceu- tical company that has lines devoted to specific products that are costly to switch over. We store the cold-chain vials in our refrigeration units until needed, and once we get the call, we then label and put the kits together and ship. As a contract packager, we can estab- lish these lines or meet other client spe- cific requirements and leverage the costs over multiple projects making the invest- ment far more cost-efective for us than it might be for the pharmaceutical com- pany first venturing into this product. We also can draw upon our experience with our projects to constantly improve upon our operations. This makes us a very attractive partner to many companies as they can draw upon our expertise as well as our packaging operations. For us, the foundation of our business as a contract packager is really trust and relationship. At the end of the day, people make deci- sions on where they want their high-cost drugs packaged, and Sharp's view is that it is an honor to be the last set of hands or equipment to touch the product before it goes out into their marketplace. As a result of this, we have been able to work with many companies as a true partner. PMP: How are Sharp's serialization capabilities being utilized? Benedict: The distribution chain of a pharmaceutical product is a long and complex one. Where the drug API is being manufactured, where the finished compound of the drug is being manu- factured, where the finished packaging is being done, where the distribution is being done, and where the patient is buy- ing or being prescribed the drug are all critical information points. Serialization laws are looking to capture the packag- ing and distribution portion of this chain with laws that are already in effect in some countries, but will be in force in the United States in January 2017 and in Europe shortly thereafter. Sharp is a leader in the field of serialization, hav- ing lines in production for over 8 years. In conjunction with serialization comes the management of the data it gener- ates. As a result, we have invested heavily in our IT functionality to stay ahead of the curve on meeting the data capture and sharing requirements that are inher- ent in today's marketplace. We have the equipment, line-level architecture in the United States and EU, as well as a cloud network where we can support a data transfer between Sharp sites, our network vendors, and the customer. Sharp has also recognized the need to put the right people in place to man- age the complexities data capture brings to the production environment. In years past, it was the packaging engi- neer and equipment engineers talking to the customer. Now we have instituted an XPReS process in working with cus- tomers. We create a team consisting of a business development person, a customer service person, a project manager, and a quality tech transfer representative. We add people for more-complex customer requirements such as a validations engi- neer, an operations engineer, an electron- ics engineer, or a package design person. Bottle counts are changing in today's healthcare market. Image courtesy Sharp Packaging Solutions

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