The following is an excerpt from an article published in the April issue of BioProcess international, entitled “Factories of the Future: Can Patient-Specific Cell Therapies Get there from Here?” The article was written by PCT’s Brian Hampson, Vice President of Global Manufacturing Sciences and Technology and Jacob Ceccarelli, Biotechnology Engineer
Cell therapy manufacturing relies upon a great deal of time, manpower and clean room space being devoted to the process, which can lead to burdening costs of goods with the overhead operating expenses associated with idle capacity. Idle capacity of the manufacturing facility—underutilized technologies, people, facilities and resources—drives cost of goods for delivery of the eventual commercialized product to unsustainable levels, a result even the young cell therapy industry has already seen demonstrated in the market. Generally, there are three strategies to address idle capacity:
Optimize Distribution of Production
With PSCT, timing is everything. Once the cells leave the patient, shipping and timing of manufacturing the therapy are crucial. Once the therapy is ready, shipping and timing of treatment back into the patient is equally as crucial. Because of this, if apheresis takes place on a Monday, for example, manufacturing and processing can only take place on Tuesday, Wednesday, or Thursday, to allow time for the therapy to be shipped back to the patient and injected during business hours before the week ends. Because of the necessary “freshness” of a cell therapy product, facilities can be left sitting idle several days a week, with overhead to pay. In this example, cryopreservation where possible is one way to optimize so that production can take place any day when a cleanroom at a facility is available, optimizing the process.
Reduce the Cost Elements of Idle Capacity
Even when production is optimized, some idle capacity is inevitable. This is where closed processing systems come into play. While closed processing systems won’t directly reduce the cost of any given unit operation, this strategy (and others mentioned earlier in the “Factory of the Future” section of this article) will reduce the overall cost by reducing space and time needed in clean rooms, thus making the total idle capacity cost more bearable.
Share Infrastructure Across Multiple Programs
In the current manufacturing system, cell therapies developers must accurately predict future market demand and anticipate how much clean room time they will need. If a developer invests the time and resources in building their own in-house manufacturing infrastructure, any time not spent using those clean rooms (if, for example, the developer overestimates market demand) becomes costly idle capacity. Using a contract manufacturer, the developer only invests in the time they will need and the manufacturing facility is used at other times for other clients’ products; idle capacity and overhead costs do not fall to the developer.
As the cell therapy industry is evolving, idle capacity is one of the challenges that has not yet been adequately considered, and standard solutions are not yet in place. But the good news is that even if a developer chooses to begin manufacturing processes in-house early on and then transfer to a contract manufacturer for late-phase and commercial development, as many developers do in today’s market, the idle capacity cost savings can still be substantial.
For more on how the industry can achieve the cell therapy factory of the future, click below to download the complimentary PDF of the complete article:
