The Healthcare Packaging & Processing Conference at next week’s PACK EXPO East 2017 will feature technology workshops and industry insights.
Maintaining a stable cold supply chain is important for refrigerated products, but it is especially critical for medicines. Managing the logistical challenges of transporting life-saving vaccines and other refrigerated medicines across varied geographies and climate zones requires special technologies. With significant growth anticipated in the use of refrigerated biopharmaceuticals on a global scale, managing cold supply chain logistics will become increasingly important, both for preventing wasted product and—most importantly—ensuring patient health.
PMMI spoke with Chris Anderson, director, quality systems, Cardinal Health regarding the intricacies of cold chain supply logistics. Anderson will be presenting at the Healthcare Packaging & Processing Conference at PACK EXPO East 2017 (Pennsylvania Convention Center, Philadelphia; Feb. 27–March 1).
How big is the market for refrigerated biopharmaceuticals?
Anderson: This is a big market, and it’s growing. According to some estimates that we have seen, sales of refrigerated biopharmaceuticals are expected to grow 65 percent from 2014 through 2020, which compares to a 34 percent growth rate of non-refrigerated medicines during the same time period. Here at Cardinal Health we witnessed a growth in our cold chain production of 110 percent between 2007 and 2015. Generally speaking, these are high value drugs. To give you an idea of this: refrigerated biopharmaceuticals represent just 4.8 percent of our product offering, but they account for nearly 20 percent of our sales.
What are some of the challenges that manufacturers face in transporting refrigerated medicines?
Anderson: The biggest challenges in transporting refrigerated drug products are maintaining an optimum temperature range, between 36°F – 46°F (2°C – 8°C). Traditional storage methods of using frozen, water-based gel packs inside of insulated containers do not always work. Just throwing a few extra gel packs can lead to products becoming too cold or frozen. This leads to product loss, especially for sensitive vaccines and protein-based therapies. Using multiple gel-packs can also add to labor and storage costs.
Over the last decade or so there has been mounting concern about the safety of refrigerated medicines, especially vaccines, with greater scrutiny from agencies such as the U.S. Food & Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO). Another challenge is that drug manufacturers are largely dependent on third parties to ensure their products are delivered safely. Once product leaves a facility, companies lose control up to the point of patient contact. Given the life-or-death nature of patient safety, the stakes couldn’t be higher. Manufacturers need to have confidence in the transportation logistics of their products.
What technologies offer alternatives to traditional water-based gel packs?
Anderson: An insulated tote with a phase change panel offers a replacement technology for traditional gel-packs. This system is designed to keep products between 36°F – 46°F (2°C – 8°C). The phase change panels look like sheets of freezer pops; a frozen green phase change panel protects products from high temperatures, while a refrigerated orange phase change panel keeps products from reaching freezing temperatures. These two panels are designed to work together to maintain the integrity of the drug product.
Is this technology effective?
Anderson: This system has proven to be effective at maintaining products within the labeled temperature storage range, and it ensures product integrity from the time of shipment to delivery. It has even worked in some of the most challenging logistical circumstances. After instituting this new technology, we were able to realize a 90 percent reduction in product damages between 2007 and 2015. Damage run rates were reduced by 95 percent, and we estimate that we save about $3.6 million annually in less damaged product.
Chris Anderson’s presentation, entitled “Sustainable and Cost-Effective Cold Chain Distribution Management,” will take place on Tuesday, Feb. 28 at 10:00—10:45 a.m. in Room 121C at PACK EXPO East. It will be part of the conference’s Supply Chain Security and Temperature Management track.
The new Healthcare Packaging & Processing Conference will offer two days of expert advice, including best approaches to serialization, automation and temperature management. It will include updates on testing and regulatory standards and strategies for processing, packaging and distribution. The cost to register for each session is now $130, according to PMMI. Registration includes access to the PACK EXPO East exhibit hall for all three days of the show.
PACK EXPO East covers a wide range of industries including food and beverage, pharmaceutical and medical device, chemical and personal care. The event will feature 400 suppliers in 100,000 square net feet of exhibit space. In addition to the Healthcare Packaging & Processing Conference, the show features an Innovation Stage, a series of free, 30-minute seminars throughout the day. Presentations include breakthrough technologies, innovative applications and proven techniques. The presentations offer lounge-style seating and a question-and-answer period with industry experts.
Late registration for PACK EXPO East is $100. To register: www.packexpoeast.com.
PMMI, The Association for Packaging and Processing Technologies, represents the interests of more than 750 North American manufacturers and suppliers of equipment, components and materials, as well as providers of related equipment and services to the packaging and processing industry. www.PMMI.org; www.PACKEXPO.com.