Automation will help the cell therapy sector reduce the number of expert staff needed to manufacture these lifesaving therapies, thereby making them more affordable.
A team, led by researchers at the Università degli Studi di Milano in Italy, made the case for automation in cell therapy production in a recent study, arguing that current manufacturing methods will not suit future industry needs.
“The rapid pace of new scientific discoveries and treatment modalities requires developers of automated systems to balance between current and future needs.
“There is no guarantee that the robust manual manufacturing strategies developed for the cell therapy industry today will be sufficient for future products,” they write.
“Instead,” the authors add, “automation should be considered a long-term asset that would provide major savings over years as demand for products increases.”
Workforce costs
The authors, who include researchers at the Center for Cancer Cell Therapy at Stanford University School of Medicine in the United States and the Sheba Medical Center in Israel, point to workforce cost reduction as the key advantage of automation.
“Current cell therapy manufacturing relies on a number of ordered steps that are generally performed by highly qualified operators,” they write, citing a hypothetical 10-day production process, involving 300-unit operations running in parallel as an example.
“The full-time employees, including manufacturing and support staff, technicians, quality assurance, quality control, and logistics, would number approximately 1,700 for a single facility. This workforce would not only be hard to find, but also economically challenging to sustain,” the authors write.
To support this take, they point to high staff attrition rates in the sector—data suggest 70% of employees change jobs every 18 months—as a cost driver, arguing, “turnover slows production and contributes to high cost because extensive training is required.”
Consistency
Automating some of the processes involved in making cell therapies would also aid product consistency and traceability, according to the authors.
“Automated systems provide reductions in product variability, manufacturing errors, risk of contamination, operator exposure to hazardous materials, and facility cleanroom requirements.
“A single employee can operate many automated systems simultaneously, increasing the number of tasks completed per unit time, supporting rapid process scalability without the need to train staff in manual processing,” they write.
In addition, because automated systems have a smaller footprint than traditional manual systems, they increase overall facility productivity.
Adoption
How quickly the cell therapy sector switches from manual methods to automated processes will depend on how willing manufacturers are to share their experiences of using such technologies with the wider industry.
“Following the open science approach, companies should publish findings regarding the performance of systems under development without compromising intellectual property.
“Indeed, generating data justifies the value of new technologies to all stakeholders: scientists with concerns surrounding the applicability of automation in cell therapy manufacturing, regulators responsible for protecting public health, and investors looking for cost-effective strategies to ensure compliance while maximizing financial returns,” they write.
Technology developers also need to ensure their systems are flexible, according to the authors.
“For the various automated systems that will come to market in the next few years, it is important to highlight that there is not a unique answer or solution that is suitable for all cell therapies. A risk-based approach must be taken in order to identify which would be most beneficial for the intended use.”