The old Boy Scout Motto, “Be Prepared,” aptly describes how World Courier, an AmerisourceBergen Corp., approaches multiple global logistics challenges in the biopharmaceutical market.
Healthcare Packaging (HCP) discussed how packaging and both internal and external global standards and guidelines help the specialty logistics firm store and transport vital biopharmaceuticals in this exclusive interview with Volker Kirchner, the company’s Director of Temperature Control Solutions, and Michael Fleischer, Global Director Quality, Transport Division at World Courier, Germany.
HCP: What products does World Courier offer, and for what different temperature ranges for shipping pharmaceuticals and biologics products?
Kirchner: We offer a range of active and passive containers to dry shippers that support cryogenic shipments. These accommodate temperature ranges that include, but not limited to low frozen (-150°C to -180°C), frozen (-15°C to -25°C), refrigerated (+2°C to +8°C) and controlled ambient (+15°C to +25°C).
Specialists at World Courier’s Climate Optimisation Research and Engineering (CORE) Labs continually evaluate packaging performance and drive solutions to help shippers make the most informed packaging decisions. In 2016, World Courier unveiled a new passive packaging solution called “Cocoon” that supports a variety of temperature ranges, including frozen, controlled ambient and refrigerated. The development of Cocoon stemmed from a conversation with one of our manufacturing clients, who needed a temperature-controlled container for a low frozen range with challenging specifications. Composed of honeycomb vacuum-insulated panels, Cocoon reduces transport costs and maintains temperature up to 40% longer than comparable products.
In recent years, both USP 1079 and EU GDP have stepped up their “ship as stored” requirements. It is now an accepted requirement that pharmaceutical product has to be shipped under conditions that are in accordance with the storage requirements indicated on the label of the medication. In other words, if the label says, “Do not store above +25°C,” this requirement must be fulfilled during transportation, too.
For shipments being sent out under uncontrolled conditions, manufacturer’s information or extended stability data must be available to support this. It explains why even products that do not require any form of refrigeration or cooling during transport would still have to be shipped out under controlled conditions.
HCP: Does World Courier ship to all continents worldwide? By air, land and sea?
Kirchner: We deliver time- and temperature-sensitive shipments to markets across the world, with an international network of 140-plus company-owned offices that span more than 50 countries. We strategically positioned our network of 14 depots in emerging markets, ranging from Australia and Israel to Russia and Brazil, to provide customers across the world with access to vital services for both commercial and clinical supply chain storage and inventory management.
We deliver shipments via air or ground to meet our customers’ unique needs no matter where they are. For example, our World Courier Ground Fleet provides a cost-effective, secure alternative to air transport. The fleet of vehicles are capable of holding six Euro-pallets, ensures that biopharmaceutical shipments arrive on time and without excursions.
For WC shipments between August 2017 and July 2018, 64.5% were transported by air, 35.5% by land and 0.001% by sea.
HCP: Describe the range of products you transport. Are these shipped primarily in pallet-load quantities? Are your customers primarily manufacturers of biologics, pharmaceuticals, etc.?
Fleischer: We transport everything from high-value commercial products to active pharmaceutical ingredients (APIs). We specialize in the transport of high-value, low-volume shipments with strict temperature control requirements—particularly liquid formulations and drugs with short shelf lives. For example, our portfolio includes the shipping of APIs and temperature-controlled specialty drugs, like biosimilars, orphan and cytostatic drugs.
HCP: How does World Courier track and record the temperature/humidity conditions of shipments to meet global compliance regulations?
Kirchner: Our robust monitoring solutions and tracking platform can deliver real-time metrics at every stage of a shipment’s journey. We leverage Global Positioning Systems (GPS), Global System for Mobile communications (GSM) and Bluetooth Low Energy technologies to track and transmit the metrics to our secure, cloud-based platform, allowing for location reporting and immediate availability of all data, including temperature, light, pressure and shock. We also use a calibrated temperature logger to record the product temperature from the origin to the destination, which enables us to demonstrate that the product remained within the appropriate temperature range.
CTM-STAR, our proprietary inventory management and stock control tool, ensures that all materials arriving or exiting any of our 14 global depots are traceable. It provides our customers with real-time visibility into stocks per protocol, stocks per depot and distribution shipments to sites.
We are investing in a multi-platform data integration initiative that will enhance the customer experience across our service offerings. The initiative will provide customers with access to deeper data insights, more advanced reporting, and enhanced customer portals for initiating and tracking shipments. The project also integrates several internal systems, allowing our associates and customers to be more connected, flexible and efficient.
Part II examines the role of global regulations and personalized therapies in World Courier’s logistics strategy.