Cell and gene therapies have the potential to revolutionize medicine. These groundbreaking treatments use living cells to target and treat disease, and they will have a profound impact on the treatment of cancer, autoimmune diseases, and beyond. However, while scientific advancements in this field are accelerating quickly, manufacturing these treatments has remained costly and slow.
The access gap between patients eligible for cell therapy and those able to receive treatment is overwhelming. About a half million patients in the United States were eligible for CAR T-cell therapies in 2020, but only about 3,000 commercial doses were produced. That’s an astonishingly small 0.6% of patients receiving these potentially life-saving treatments.
As new indications for cell therapies continue to be approved by regulatory bodies, cancer rates are seeing a massive upward trend. These factors will increase the number of patients eligible for these therapies, worsening the manufacturing shortfall.
With patients dying on waiting lists for these lifesaving treatments, the stakes could not be higher. So how can manufacturers deliver cost-effective cell therapy at scale?
Closed manufacturing systems contain robotics and automated processes in a sealed environment, delivering an end-to-end solution for cell therapy production. These systems can bridge the gap between scientific breakthroughs and widespread patient access to cell and gene therapy.
Current Constraints: Manual, Error-Prone Processes
Today, cell therapy manufacturing is hindered by a reliance on open systems. In an open system, most tasks are done manually by skilled personnel. Culturing and expanding cells in large quantities, ensuring their viability and functionality, and maintaining consistent quality throughout the production is very complex and time-consuming.
With this approach, it can take 50 or more manual processing steps on benchtop instruments to produce a single therapy for just one patient. Due to challenging working conditions, long shifts, and complex tasks, the turnover rate in cell therapy manufacturing is a staggering 70%.
Manual processes not only drive high costs, but they have a high potential for errors. Manual processing is susceptible to contamination and variability, making it impossible to deliver a precise, reliable solution at scale.
Closed Systems for Quality and Consistency
Closed manufacturing systems utilize sophisticated bioreactors and bioprocessing equipment designed to cultivate and manipulate cells within a sealed, aseptic environment. These systems not only minimize the risk of contamination but also enable real-time monitoring and control of critical process parameters which are essential for ensuring the safety and efficacy of treatments. Automation plays a pivotal role by streamlining production processes and reducing the need for manual intervention, which in turn enhances efficiency and minimizes errors.
Automation and closed manufacturing systems address the access gap head-on. Whether it be the production of off-the-shelf allogeneic therapies or patient-specific autologous treatments, closed systems offer a versatile and adaptable platform capable of accommodating diverse manufacturing requirements. By standardizing manufacturing processes, closed systems also foster greater consistency in product quality—a factor critical for achieving regulatory approval and garnering confidence from healthcare providers and payers.
Decentralized Production, Localized Access
Because a closed system uses automation to ensure quality and consistency, it does a far better job replicating quality standards locally when compared to manual, open systems that are susceptible to human error and other variables. Therefore, closed manufacturing systems can help to decentralize cell therapy production by enabling the establishment of smaller-scale manufacturing facilities closer to patient populations. This reduces the need for centralized manufacturing hubs and facilitates personalized or regionalized production of cell therapies.
Establishing production facilities closer to patients, especially in remote or underserved areas, can improve patient outcomes by reducing transportation time and increasing accessibility to care.
Additionally, localized production enables more flexible scaling of capacity to meet demand variations and ensures compliance with regulations governing transportation and distribution.
The transformative potential of closed manufacturing systems extends beyond the realm of cell therapy, offering a blueprint for innovation across the broader field of biomanufacturing. The principles and technologies underpinning closed systems—automation, real-time monitoring, and process control—have far-reaching implications for the production of biologics, vaccines, and other advanced therapeutics.
By offering scalability, standardization, and efficiency, closed systems will help deliver the full potential of cell-based treatments, ushering in a new era of personalized medicine. As we continue to unlock the mysteries of cellular biology and harness the power of regenerative medicine, closed manufacturing systems will undoubtedly play a pivotal role in shaping the future of healthcare—a future where life-saving therapies are affordable and available to all who need them.
Don’t miss your opportunity to shape the future of medicine. If you are 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 developing complex instrumentation, with extensive experience guiding teams through the product development framework, particularly in the medical device industry. As the Director of Engineering and Program Management at Ascential Technologies, he has a proven track record of successfully executing sophisticated medical device programs that recently includes an ISO 13485 medical IVD platform. His expertise extends to creating cutting-edge solutions and driving projects through the end-to-end commercialization process.
