The topic of end-to-end (E2E) design of supply chains has become a high priority for almost every industry. Even before the Coronavirus disease (COVID-19) pandemic started, many sectors focused on this concept, particularly industries that worked to re-invent their supply chains to launch products more quickly, reduce costs or develop new routes to market. The pandemic has only heightened the importance of this area and raised the general public's awareness of this topic. Some industries and companies have been real leaders in this area for decades.
When industries and companies are in the early stages of designing and executing an optimized E2E supply chain design, it is essential to understand how decisions can make a significant difference further down the line. It is a complicated process and requires breaking down typical silos within the organization to develop a common strategy and understand trade-offs.
In the life sciences industry, innovation in E2E supply chain design is a fairly new priority. Companies have focused on risk mitigation and quality systems for quite a while. However, stepping back and thinking through the E2E design, from the patient and clinician all the way upstream to critical raw materials, is newer. Many pilots and new tools are being explored, but there is a lot of room for a truly optimized supply chain.
Why the cell therapy sector should focus on E2E supply chain design
Within this broad sector, cell therapy is a new area of biotechnology, using human cells to develop new therapies for unmet patient needs. With so many new treatments in development, current attention is focused on the underlying science and early trial read-outs. These new therapeutics and trial results are an important marker of near-term success. Once these therapies are proven and demand grows, supplying those therapies at-scale will be the next challenge. Preparing for this can take years, and while just beyond the horizon, it should be a strategic focus now.
There are three broad areas needing attention for cell therapy to be truly scalable -- reliable supply of unique raw materials and consumables, logistics from production to patient and data capture and analytics to streamline and de-risk the entire operation.
Reliable supply of raw materials and consumables
Each final dose of cell therapy may have hundreds of components in a bill of materials. Many are readily available at scale, yet several important components are unique to cell therapy processes and need special attention to move from small-scale trials to commercial production. Harvesting, tracking and storing the cells is a major effort. In addition, critical raw materials to support cell growth are often produced by smaller suppliers who will need to build capacity and reliability to keep up with demand. Finally, many cell therapies are produced using single-use bioprocessing systems. These systems have many benefits in simplifying the production process. Yet, the number of disposable containers and bags required for each batch can be significant, requiring many thousands of consumables over the course of a year for each line. Many of these containers and bags are small, but some take up an entire pallet. Storing, handling and disposing of these materials will require a new level of careful handling for the industry.
Logistics from production to patient
In addition to meeting industry standards for security and traceability, cell therapies may require an "ultra-cold" chain from production to patient. While the pharmaceutical industry has an extensive network of cold chain logistics capabilities for many common treatments, such as the MMR vaccine, these cold chain logistic capabilities often are set up to handle doses in a temperature-controlled manner, around 2-8°C. Many cell therapies, by contrast, must be maintained at temperatures as low as -140°C. Anyone following the Pfizer COVID-19 vaccine distribution has come across a description of the logistics developed, including a giant freezer farm in Michigan. Now project that logistical concept to therapies that are used every day in clinical care for stroke or trauma patients, which are urgent and unscheduled, and the storage and handling of these doses pick up new relevance. Establishing a system that is easy to use and access by the clinician or hospital pharmacy staff will be an important step toward enabling the efficient delivery of doses at scale.
The rapid advances in data analytics, cloud storage and GPS tools currently on the market provide a significant opportunity for the cell therapy industry. While the life sciences industry has focused for years on tracking data from supplier through production to patient, in many cases, records are paper-based and there are major hand-offs across companies. For cell therapy, there is an opportunity to consider digital tools from the beginning to streamline data capture and create a data architecture that grows with the company and improves analysis and tracking, even during trials. As many cell therapy companies are young, they are not locked into cumbersome legacy systems. They can deploy the latest technologies, combining data historians and work instructions in production with flexible enterprise resource planning (ERP) systems to capture and analyze every aspect of production. These new tools will also support the "last mile," where companies will be able to track doses stored at individual hospitals and used with individual patients.
In summary, while scientists are innovating important new cell therapies to help patients across the world, operations and supply chain teams are at work innovating the best ways to produce and move doses to patients in a way that supports clinicians and maintains and tracks high-quality doses across the end-to-end supply chain.