Issue link: https://www.e-digitaleditions.com/i/1373953
Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 43 instance, if a product is shipped using a particular lane or packaging type, during a specific time of year, prescriptive analytics can help people under- stand scenarios that are likely to occur. Informa- tion like this is crucial to prevent product waste and stock outages, as well as determine the best route or packaging material. Technologies such as Controlant's include integration of multiple sys- tems and connect the physical and digital supply chains together. Moving ahead, we are seeing supply chains in- creasingly focusing on building supply-chain re- silience, which includes real-time visibility, agility, and responsiveness. More businesses are interested in integrating their manufacturing, operations, and supply chains to automate processes, increase efficiency, and improve communication among internal and external stakeholders. More broadly, healthcare supply chains are com- plex and have grown more so as they have incor- porated many different organizations within them. They also require tech integrations with multiple systems and are working with a wide variety of stakeholders. Manufacturers need to nimbly pivot between suppliers and carriers based on market, regional, or customer demands while also operat- ing within governmental regulations. Each vari- able increases the complexity, which adds risks throughout the supply chain. Some companies have already begun [making] their supply chains [more complex] by recruiting additional suppliers. Others have started to inte- grate their supply chains more closely with their suppliers, logistics providers, and customers. Re- silience is required to meet track and trace, moni- toring, regulatory, and licensing requirements. To achieve this level of resilience, pharma companies are beginning to strategize and implement smarter solutions to deliver full digitization to every part of their supply chain operations. Veerina (Cloudleaf): Digital visibility technology was available before, but the pandemic has accel- erated implementation, and not just with the big names but with the whole ecosystem of bulk pro- ducers of materials used to make the vaccines, and the packagers and distributors. We are seeing that the crisis is driving innovation. A secondary benefit to supply chain visibility is that companies that collect data over time can then use data analytics to proactively evaluate issues such as which routes or carriers are more prone to excursions or how routes and standard operating procedures can be optimized. In addition, new technologies that are being evaluated and should soon be launched include inexpensive sensors that can be attached to each vial to automate tracking of vaccine doses at the point of care and incorporate these data into vis- ibility systems. These types of systems can be used to benefit other areas in biopharmaceutical manu- facturing. For example, in blood plasma manufac- turing, inexpensive sensors could be put on every bottle and used to further automate. Another area is cell and gene therapies, which are very expensive and growing very rapidly. Digital visibility systems can revolutionize this space with end-to-end vis- ibility all the way to patient care. References 1. Pfizer, "Pfizer and BioNTech Submit COVID-19 Vaccine Sta- bility Data at Standard Freezer Temperature to the US FDA," Press Release, Feb. 19, 2021. 2. J. Markarian, "Accelerating Technology Adoption to Track the Cold Chain," PharmTech.com, Jan. 14, 2021. 3. Cold Chain Technologies, "Cold Chain Technologies Partners with Cloudleaf to Provide Enhanced Real-Time Visibility for End-to-Distribution for Temperature-Sensitive Drugs and Bio- logics," Press Release, March 16, 2021. PT