Because patients can’t wait

Sept. 29, 2020
How autologous cell therapy companies can adapt planning processes to maintain operations amid supply chain disruptions.

The COVID-19 pandemic has affected life sciences organizations across the world and has led them to adapt in various ways. This is especially true for companies working on autologous cell therapies, which are dependent on complex supply chains for coordinating patients, practitioners and manufacturers. Autologous cell therapies require a flexible manufacturing capacity and a highly skilled workforce, which places these intricate supply chains at risk of disruption in the current uncertain climate.

The chain of custody for these live cells is critical to ensuring the safe and timely treatment of patients. Outside of cell collection and shipping to and from the treatment center, the “one patient, one batch” manufacturing process requires a broad range of materials and consumables. Furthermore, little of this work can be completed remotely. From cell collection at the clinical sites to administration of the engineered cells at the clinical site, people are needed to complete the work. With the challenges imposed by the risk of COVID-19, extra steps and diligence are required to ensure all processes are carried out properly.

Expecting the unexpected

The COVID-19 pandemic has created unique challenges for the manufacturing process behind autologous cell therapies, such as its impact on the availability of raw materials due to the additional need for personal protective equipment (PPE). In addition, suppliers may be experiencing reduced manufacturing capacity because employees may be out sick or caring for others during the pandemic. There is also uncertainty concerning delivery dates for materials because some suppliers source from countries that may be particularly hard hit by COVID-19. To mitigate potential shortages, companies need to increase their inventories of critical materials and implement secondary source planning.

In terms of logistics, shipping of the cellular starting material and final drug product is typically done via air with time limits due to the stability of the material being transported. With the pandemic limiting travel, flights have been cancelled on a moment’s notice, leaving companies with no choice but to source last-minute alternatives. This scenario should drive companies to consider road transit, when possible, to mitigate against unexpected flight cancellations. In addition, contingency plans should be prepared with logistics partners to transport cells via chartered flights if no other transport solutions are available.

Additionally, the imposed quarantines and restrictive measures needed because of the COVID-19 outbreak have affected internal operations. Autologous cell therapy companies need to manage employees’ schedules and work environments to make certain essential employees are safe while conducting critical operations. In tandem, companies must mitigate the risk of employees contaminating the drug product with the virus. This can be achieved by implementing a work-from-home policy for employees when feasible, executing social distancing measures on site, enhancing cleaning routines, and adding PPE and temperature checks for employees that must be on location.

The patient perspective

Companies must also be conscious of the issues raised by the COVID-19 outbreak as they relate to the patient journey. Current circumstances may leave patients unable to travel to the clinical site and forced to social distance out of fears for their health. Ultimately, these challenges mean companies need to work on a site-by-site, patient-by-patient basis to do everything they can to supply autologous cell therapies to people who are particularly vulnerable, such as patients undergoing treatment for cancer. Alternate treatment sites are being utilized to provide a location closer to the patient and not as heavily impacted as large institutions. This can make the patient journey easier in a way that also mitigates potential exposure to COVID-19 at large treatment centers.

During these unprecedented times of global uncertainty, there are a multitude of factors affecting every aspect of the supply chain for these autologous cell therapies. It is vital that autologous cell therapy companies quickly and efficiently adapt planning processes to ensure they are able to maintain operations and manufacturing — because we know patients can’t wait.

About the Author

Mike Blankenstein Senior Director | Patient Supply Operations Manufacturing and Supply Chain

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