Cell and gene therapies have the potential to revolutionize medicine. These breakthrough treatments use living cells to target and treat diseases, and they will have a profound impact on the treatment of cancer, autoimmune diseases, and more. However, while scientific progress in this field is accelerating rapidly, manufacturing these treatments remains expensive and slow.
The access gap between patients eligible for cell therapy and those able to receive treatment is enormous. Approximately half a million patients in the United States were eligible for CAR T-cell therapies in 2020, but only 3,000 commercial doses were produced. That’s a surprisingly small 0.6% of patients receiving these potentially life-saving treatments.
As new indications for cell therapies continue to be approved by regulatory agencies, cancer rates are experiencing a massive upward trend. These factors will increase the number of patients eligible for these therapies, further exacerbating the manufacturing gap.
With patients dying on waiting lists for these lifesaving treatments, the stakes couldn’t be higher. So how can manufacturers deliver cost-effective cell therapy at scale?
Closed manufacturing systems Cell therapy production systems contain robots and automated processes in a sealed environment, providing an end-to-end solution for cell therapy production. These systems can bridge the gap between scientific advances and widespread patient access to cell and gene therapy.
Current constraints: manual and error-prone processes
Today, cell therapy manufacturing is hampered by reliance on open systems. In an open system, most tasks are performed manually by trained personnel. Cultivating and expanding cells in large quantities, ensuring their viability and functionality, and maintaining consistent quality throughout production are highly complex and time-consuming operations.
With this approach, it can take more than 50 manual processing steps on benchtop instruments to produce a single therapy for a single patient. Due to the harsh working conditions, long workdays and complex tasks, the turnover rate in cell therapy manufacturing is as high as 70%.
Manual processes not only incur high costs, but also have a high risk of errors. Manual processing is prone to contamination and variability, making it impossible to deliver an accurate and reliable solution at scale.
Closed systems for quality and consistency
Closed manufacturing systems use sophisticated bioreactors and bioprocessing equipment designed to grow and manipulate cells in an aseptic, sealed environment. These systems not only minimize the risk of contamination, but also enable real-time monitoring and control of critical process parameters, essential to ensuring the safety and efficacy of treatments. Automation plays a vital role in streamlining production processes and reducing the need for manual intervention, improving efficiency and minimizing errors.
Automation and closed manufacturing systems are helping to address the access gap. Whether producing off-the-shelf allogeneic therapies or patient-specific autologous treatments, closed systems offer a versatile and adaptable platform that can meet diverse manufacturing requirements. By standardizing manufacturing processes, closed systems also promote greater consistency in product quality, a critical factor in gaining regulatory approval and the trust of healthcare providers and payers.
Decentralized production, localized access
Because a closed system uses automation to ensure quality and consistency, it replicates quality standards locally much better than manual and open systems, which are prone to human error and other variables. Therefore, closed manufacturing systems can help decentralize cell therapy production by enabling the creation of smaller-scale manufacturing facilities closer to patient populations. This reduces the need for centralized manufacturing centers and facilitates customized or regionalized cell therapy production.
Establishing production facilities closer to patients, particularly in remote or underserved areas, can improve patient outcomes by reducing travel time and increasing accessibility to care.
In addition, localized production allows for more flexible adaptation of capacities to meet variations in demand and ensures compliance with regulations governing transport and distribution.
The transformative potential of closed manufacturing systems extends beyond the field of cell therapy and offers a model for innovation in the broader field of biomanufacturing. The principles and technologies underlying closed systems—automation, real-time monitoring, and process control—have far-reaching implications for the production of biologics, vaccines, and other advanced therapies.
By offering scalability, standardization, and efficiency, closed systems will help unlock the full potential of cell-based therapies, ushering in a new era of personalized medicine. As we continue to unravel the mysteries of cell biology and harness the power of regenerative medicine, closed manufacturing systems will undoubtedly play a critical role in the future of healthcare—a future where life-saving therapies are affordable and accessible to all who need them.
Don’t miss your opportunity to shape the future of medicine. If you’re ready to integrate automation and closed systems into your manufacturing processes, the Ascential team is here to help.
About Joe Wong
Joe Wong is a seasoned leader in the development of complex instruments, with extensive experience in supporting teams in product development, particularly in the medical device industry. As Director of Engineering and Program Management at Ascential TechnologiesHe has a proven track record of successfully executing sophisticated medical device programs, most recently an ISO 13485 medical IVD platform. His expertise extends to creating cutting-edge solutions and leading projects throughout the end-to-end commercialization process.
