The Food and Drug Administration (FDA) and related industries estimate 40 new cell and gene therapies to be available by 2024 in addition to the 800 already being processed. While beneficial to patients and further research, these advancements have introduced new challenges in logistics and distribution including delivery methods, scalability, marketing factors, and stakeholder partnerships.
Delivery strategy is currently an ongoing challenge in safely transporting living cells. Companies must choose between fresh and frozen cell transportation, along with viral and non-viral delivery. Gene and cell therapies introduced the concept that the patient is part of the supply chain for a time-sensitive product. This presses companies for faster delivery and introduces the need for reimbursement strategies and decreases in cost.
Furthermore, transporting cells is a relatively new advancement, requiring adjustments to previous methods of transportation. There are currently three packaging methods being utilized: active, semi-active, and passive packaging that relies on external sources, static cold sources, or eutectic plates. Quality control also inflicts challenges on distribution, encouraging real time monitoring and tracking through GPS. Usage relies heavily on transportation and appropriate packaging methods, making it critical to coordinate airline routes, schedules, and customs regulations.
Once delivery is complete, cells still have a limited shelf life, requiring time for acclimation and use. Cells are generally used within a 2-hour time period, a challengingly short time frame for both patients and doctors.
Beyond distribution, many companies have limited manufacturing capacity and technology. Currently it is important that companies coordinate with experienced and resource rich partners that can offer analytical technologies both for manufacturing and improving quality control.
While making decisions about delivery and manufacturing, companies must also consider the current and future market. Patient population is a key feature during the early stages of production, along with deciding dosages and the conditions under which the treatment must be stored.
As more individuals become reliant on gene and cell therapy, the development of more therapies will be approved by the FDA. With this growth comes difficulties in logistics and distribution, however, companies and their partners are learning and continuing to improve production and distribution to address the growing demand.