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As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.
The past few years have seen the commercialization of personalized therapies (e.g., chimeric antigen receptor [CAR]-T and other genetically modified cell therapies and gene therapies) and a shift from traditional to direct-to-patient clinical trials. Both developments are having a major impact, not only on pharmaceutical manufacturing and quality, but on supply-chain management, as third-party logistics companies and shipping specialists emphasize solutions designed for sensitive biologics and for new clinical trial models.
While the cold-chain packaging designs targeting this market continue to improve, companies within the pharma supply chain are moving to digitization. More are embracing technologies that allow for continuous real-time product monitoring during transport, using advanced data analytics and leverage the Internet of Things (IoT) and artificial intelligence (AI).
A 2018 survey of 100 biopharmaceutical and pharmaceutical company managers (1) found that most of them were embracing new technology to improve traceability and efficiency, to intercept shipments to prevent loss, and to increase forecasting accuracy. Considering the type of technology, 63% said they were using supply chain analytics, 37% were using advanced data analytics, 29% were actively using artificial intelligence, and 19% were using IoT, although 35% said they were implementing AI-based solutions. They also saw new technology as a way to optimize cold-chain spending. The survey found that 54% of respondents said they’d overspent on temperature control in over 25% of shipments, while 24% said they had underspent (1).
Working directly with technology vendors such as Controlant, Elpro, OnAsset Intelligence, TSS, and Cloverleaf, or collaborating with shipping specialists that use vendor-supplied or in-house platforms, pharmaceutical companies find that the technology increases visibility and offers the opportunity to respond quickly to problems during material transit. Allergan Pharmaceuticals has found that Controlant’s real-time monitoring platform has improved data retrieval and removed supply-chain blind spots, according to Tommy Jennings, associate director of Allergan in Ireland (1).
Having access to data analytics can allow the root cause of logistics problems to be determined quickly, and, over time, permits companies to take a “manage by exception” approach, said Ada Palmadottir, Controlant’s business development director in a webcast (2). In one case, during truck shipment, the real-time monitoring system detected a temperature excursion, although the data logger on the truck did not. Ultimately, the problem was traced to the fact that the back window of the truck had not been shut completely after a customs check and let cold air into the vehicle, explained Palmadottir during the webcast.
As patient-centered clinical trials transform biopharmaceutical logistics, personalized therapies demand transport at much lower temperatures. Packaging providers have responded by improving existing active and passive temperature-control methods and both reusable and single-use designs.
Pelican Biothermal Co., for instance, offers reusable passive shippers, such as Credo thermal containers, the Credo Cube and Sherpa single-use container system (3,4). Sonoco ThermoSafe offers a variety of shippers for use in cell and gene therapy clinical trials (5). Marken recently introduced SmartBox (6), while Aerosafe Global‘s Aerocore packaging can operate from -65° C– 25° C for 24 to 120 h. In 2018, the company introduced A-20 single-use packaging (7).
Diversified transportation companies offer web-based monitoring systems that allow shipments to be tracked, some of them in real time. Cryoport, which has become increasingly active in cell and gene therapy over the past four years (8), offers recyclable Cryoport Express shippers which are used in the company’s Cryoport SmartPak II condition-monitoring system, connected via the company’s CryoPortal cloud-based network (9).
Sunoco ThermoSafe’s PharmaPort platform offers shipping containers with sensors that allow for real-time condition monitoring via the company’s web-based system (10). Envirotainer offers active temperature control technologies with products such as its RAPT2 container and introduced a customer portal with expanded functionality in June 2019 (11). Marken provides the SENTRY condition-monitoring system, which provides uses with hourly updates (12).
The company offers specialized capabilities for shipping both single-patient (allogeneic) and multi-patient (autologous) cell therapies (13,14). AmerisourceBergen’s World Courier subsidiary recently introduced Cocoon, a pallet-loading device that is designed for applications where very strict temperature controls are required (15). In May 2019, World Courier teamed up with GE Healthcare to integrate parts of GE’s Flex Factory with World Courier’s controlled temperature solutions for cell and gene therapy (16).
Manufacturers can also turn to a wider number of solutions that allow for continuous monitoring of cargo-not only for temperature but other vital conditions such as humidity and vibration. Cloudleaf, for example, offers Sensor Fabric, a network of sensors using IoT servers and gateways that collect information that is monitored via a control center. The technology has been used to optimize transport of plasma samples (17). Sendum Wireless Corp., meanwhile, offers the Findum real-time monitoring platform and recently introduced a tracking system and sensor that can handle cryogenic level temperatures (18).
1. Logipharma, Increasing Visibility with Real-Time Data, logipharma.eu.wbresearch.com, August 2018.
2. Controlant, How to Leverage Digital Transformation and Real-Time Monitoring, Webcast, May 2019.
3. Pelican Biothermal, Pelican Credo Cube Product Data Web Page, pelicanbiothermal.com.
4. Pelican Biothermal, Sherpa Single-Use Packaging System Product Data Web Page, pelicanbiothermal.com.
5. Sunoco Thermosafe Product Data Web Page, Pharmaport, thermosafe.com.
6. Marken, Smart Box Product Data Web Page, marken.com.
7. N. Basta, “Aerosafe Expands Its Product Line,” pharmaceuticalcommerce.com, Nov. 16, 2018.
8. V. Barba, “Cryoport’s CEO on Cell Therapies Market Robust Demand,” biopharma-reporter.com, April 22, 2019.
9. Cryoport, SmartPak Condition Monitoring System, cryoport.com, 2018.
10. N. Basta, “The New PharmaPort360: A Solution for Challenging Journeys in Global Logistics,” pharmaceuticalcommerce.com, May 3, 2019.
11. Envirotainer, “New Online Services on Envirotainer Customer Portal,” Press Release, June 2019.
12. Marken, Sentry Demonstration Video, vimeo.com, 2017.
13. Marken, Services Capabilities Web Page, marken.com, 2018.
14. Marken, “Speed and Flexibility to Deliver Temperature-Sensitive Immunotherapies Anywhere,” marken.com, July 19, 2018.
15. World Courier, Cocoon User Guide Video, worldcourier.com, May 2019.
16. World Courier, “GE and World Courier Collaborate to Drive Commercialization of Cell and Gene Therapies,” Press Release, June 2018.
17. Cloudleaf, Case Study, cloudleaf.com, June 2018.
18. Sendum Wireless, “New Temperature Probe,” Press Release, May 2019.
Vol. 43, No. 8
When referring to this article, please cite it as A. Shanley, “Real-Time Monitoring Drives New Logistics Solutions,"Pharmaceutical Technology 43 (8) 2019.