By 2024 experts predict that five out of the top ten best-selling drugs will require refrigerated storage and handling. Between 2018 and 2024 there is a projected 50% growth in global biopharma sales for cold chain products, growing at approximately twice the rate of non-cold chain products.
At last week’s HDA Distribution Management Conference, Ann Pham, Director of Business Development at third party logistics provider ICS, discussed cold chain considerations from a 3PL’s point of view. She said that COVID-19 caused significant disruption to pharmaceutical supply channels, but the pandemic alerted the entire industry to become better prepared in the event of a future incident. “At the 3PL level refining and renewing previously developed supply chain, risk management, and business continuity planning strategies became a focus, as well as storing product across multiple locations to decrease the risk event,” said Pham.
As cold chain logistics increase in both importance and complexity, evaluating the supply chain or distribution strategy, analyzing solutions and associated costs, and identifying channel partners can seem daunting. And according to the Institute for Human Data Science (IQVIA), the biopharma industry loses approximately $35 billion annually due to failures in temperature control logistics. “Temperature, excursions, or deviations from required storage and shipping conditions are a major concern for pharmaceutical manufacturers,” said Pham. “This was especially critical as we looked at the COVID-19 vaccine and associated therapy roll-outs because of the widespread concern that improper cold chain storage and handling would add to the pandemic crisis. But we saw tremendous collaboration amongst government agencies, manufacturers, 3PLs, and other supply chain partners, to build rigorous yet flexible logistic strategies that enable the safe and secure distribution of vaccines and therapies around the world. The strategy collaboration in conjunction with the significant investments 3PL's have made in recent years to build out their cold chain storage and distribution capabilities made the vaccine rollout successful.”
Pham added the collective experience and capabilities to support temperature sensitive products was in place, but alignment was needed on a plan to support rapid scale distribution with complex means. For example, if products with ultra-frozen requirements weren't distributed until after the vaccine doses thawed and the doses then needed refrigerated storage, it enabled supply chain partners to distribute vaccines at a more common temperature range, but it also required precise execution and coordination amongst all stakeholders to ensure that vaccines and therapies were delivered in a timely manner and administered within their short shelf life. She said, “We're taking the lessons learned from the COVID-19 vaccine and therapy roll out and applying them to our strategy as service providers. We understood the need to pivot quickly due to new demands on experience and capabilities, and to support these temperature sensitive products. Now more than ever the need for collaboration and communication across stakeholders throughout the product journey is key.”
An excursion event involves a Time Temperature Sensitive Pharmaceutical Product (TTSPP) being exposed to temperatures outside the range(s) prescribed for storage and/or transport. What to do in the event of an excursion, and processes and tools for handling cold chain product, are both critical factors in successful management of a cold chain logistics program. The key to avoiding temperature excursions is knowledge of the product and product journey, and pre-planning for the most common challenges that occur along the way. “By engaging 3PL's early in the commercialization process, pharmaceutical companies and their partners can design and execute a robust supply chain strategy that leverages flexibility, storage across different areas, and the right packaging solutions, to maintain product integrity across all conditions,” Pham said.
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Pack-Out Solutions: Qualified vs. Validated
There are multiple pack-out solutions, or shippers. A qualified pack-out includes a container and supplies specifically designed for use when packing product for transport and is “qualified” through International Safe Transit Association (ISTA) testing on minimum and maximum temperature ranges - often referred to as allowable excursions - which are supported by stability and other studies. This testing under controlled conditions ensures the shipper can achieve and maintain desired temperatures for a set amount of time.
Validation is taking a qualified pack-out and validating the actual temperature range time. Validation is typically performed by the manufacturer’s quality team, which evaluates the duration or the time that it takes the completed package to be closed and sealed at the point of departure, until it is opened at the point of arrival. “Using a custom pack-out versus one that your 3PL can provide,” said Pham, “oftentimes comes down to understanding the product specific handling and temperature requirements. Cost is also a consideration. Your 3PL's standard qualified pack-out will be a less expensive solution than a custom pack-out. There is also a myriad of temperature-controlled transportation options as well, whether it's by truck, air, or larger container. Temperature loggers also operate to give clear evidence of temperature stability throughout the transit of your package.”
Monitoring innovations such as GPS and GSM technology allow for real-time tracking of the shipment and can also be utilized through loggers with live transmission and location reporting, providing immediate availability of data. The metrics that these trackers typically include are temperature, lights, pressure, and shock. Pham said that a 3PL provider should be able to provide standard tracking information for all outbound shipments that leave their facility, providing full visibility to when a shipment was picked up by a carrier, status updates, and proof of delivery. A 3PL provider should also have the ability to provide these options and the various costs associated with them to aid in your analysis from both a dollar and quality perspective, said Pham.
PACK EXPO Las Vegas and Healthcare Packaging EXPO (Sept. 27-29, Las Vegas Convention Center) will reunite the packaging and processing community. With over 1400 exhibitors, no other event in 2021 will bring together a more comprehensive gathering of suppliers offering new products, technologies and solutions. Attendee registration is now open.