Issue link: https://www.e-digitaleditions.com/i/1507932
26 BioPharm International ® Emerging Therapies eBook September 2023 www.biopharminternational.com Supply Chain "With CGT and other personalized therapies, it is critical to arrange a tightly coordinated timeline w it h h ig h ly choreog raphed ha ndof fs a mong a l l par ties involved. If you don't have good visibilit y and tight control at every step of the way, there can be big cl i n ica l a nd f i na ncia l i mpl icat ions," says Samantha Betancourt, SVP marketing and strategy for UPS Healthcare. "At the end of the day, you don't necessarily see how many hands handled the package throughout the process, but the work that goes on behind the scenes is immense and essential." "When you go direct to the patient—as is the case with CGT shipments and other personalized medi- cines—it reduces the layers in the supply chain and gets us even closer to the ultimate patient, who is usually literally sitting in a hospital room or clinic waiting for the critical infusion and hopeful that the product de- livery (out part) goes off without any issues," notes Rob Coyle, SVP, Healthcare Strategy, Kuehne+Nagel (K+N), whose cold chain delivery infrastructure includes more than 240 certified locations in more than 60 countries. "The ultimate challenge for our customers is, of course, to ensure that their valuable, life-saving prod- ucts arrive at their end point and ultimately reach the patient on time and intact," adds Emanuel Schäpper, team lead, key accounts for ELPRO, a global provider of environmental monitoring solutions, cold chain data intelligence, and GxP services. "Stakeholders go to great lengths when it comes to selecting the most appropriate containers and packaging, choos- ing the right transport route, partnering with the right service provider, and implementing the right monitoring solution." From an operational point of view, monitoring solu- tions that are designed for smaller, highly individual- ized CGT shipments must be easy to use, reliable, and above all, they must clearly display the important in- formation in a user-friendly format. For example, cer- tain containers of CGT material must not be tilted or exposed to unnecessary light, so additional data loggers will be needed for those instances. "Mounting brackets and matching external probes are available for this pur- pose," says Schäpper. "This allows the responsible per- sons to view and analyze the measurement and event data via a cloud application." For some biologics deliveries "the stakeholders only need to know when the parcel gets picked up, when it is in transit, when it is at the manufacturing facility and when it is on the way back to the clinic," says Betan- court. However, in other instances, "the stakeholders want or need to know exactly where the parcel is at every moment and keep a close eye on all of the critical parameters that could imperil the critical cargo inside the package," she continues. Toward that end, the UPS Premier product, devel- oped specifically to serve the pharmaceutical, med- ical device, and laboratory industries, is structured in three different tiers that lets customers choose the level of technology and service that is required wh i le ba la nci ng cost con siderat ion s. T he t h ree Premier levels are: • Premier Silver incorporates an radio frequency identif ication (RFID) sensor into the package label to provide point-in-time tracking of pack- age location and timing throughout the journey. • Premier Gold affixes a mesh Internet of Things (IoT) sensor (the size of a credit card) to the pack- age to provide 24/7 monitoring and visibilit y regarding location and timing. Additional pro- tection comes through access to live agents at the company's healthcare-dedicated command center who can intervene quickly in the face of bottlenecks and disruptions. • Premier Platinum leverages cellular and GPS tracking technology to provide precise location detail throughout a shipment's journey and in- cludes sensors to measure temperature, light, and humidity of the payload in the package. Standardized versus proprietary digital platforms Improved end-to-end supply chain digitalization is essential for improving the overall orchestration of the complex supply chain ecosystem that is required to support closed-loop, vein-to-vein CGT products and processes. Multiple courier pickups—each requiring continuous chain-of-custody and chain-of-identif y verification throughout every handoff—are needed to collect the patient's extracted blood or tissue from hospital or apheresis center, deliver the collected cells to the specialt y manufacturing facilit y, pick up the engineered therapy, and deliver it back to the treatment center in time for the scheduled infusion back into the patient. "Managing t h is complex cel l journey requires that all activities are completed appropriately and accord i ng to t he ag reed-upon schedu le w it h no temperature deviation," says John Bermudez, vice president, product marketing for TraceLink, which operates the TraceLink Opus Platform that creates secure, interoperable digita l net works for a l l in- dustr y par ticipants using a common data model. The company is in the process of building a "cell jou r ney solut ion" t hat w i l l a l low a l l pa r t ies i n- volved in complex, multi-step CGT storage and dis- tribution processes to work within the company's unified digital platform. "There are already many world-class companies out there supplying state-of-the-art technologies for temperature-controlled packaging, sensors, data-an- alytics capabilities and a lot of experienced cold chain couriers," says Bermudez. "However, the process of tying all of these parties together on a unified digital