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By Eytan Abraham, PhD, and Bruce Thompson, PhD
While cell therapies are still a small segment of therapeutics, the landscape is rapidly changing with over 1,000 ongoing clinical trials and several recent commercial approvals. Scalable biomanufacturing for cell therapies is crucial to making these therapeutic products successful and accessible to more patients. But gaps in capacity and technologies are holding these therapies back from wide adoption.
Cell therapies have now proven themselves in the clinic and are increasingly becoming viable third- and even second-line treatment options. What are the key bottlenecks that must be addressed before these therapies can reach their full potential?
The cost of these therapies, especially for non-life-threatening indications, is too high, partly due to the convergence of three main components: the high cost of goods sold (COGS), lack of scalability, and absence of in-depth analytics that support product understanding to enable a path to commercial licensure.
The COGS issue encompasses many elements. The key drivers are the length, complexity, and manual nature of many processes and the quality control (QC) processes. These result not only in high COGS but also in manufacturing deviations that can result in batch failures.
Other bottlenecks sit in process and analytical development. Highly complex therapeutic modalities are often difficult to characterize, and direct correlations to clinical efficacy have been elusive to date. Chemistry, manufacturing, and controls (CMC) organizations are under tremendous pressure to conduct the appropriate process design and heightened analytical characterization studies.
What are some of the solutions to improve cost and scalability?
The solutions are technological at heart—closed, automated processes run in equipment that requires minimal cleanroom space and enables a reduction in cleanroom grade.
Better process and product analytics will lead to higher batch-release success rates and a deeper understanding of the links between process and product, which all pertain to clinical efficacy. The use of antiquated QC methods do not support the data, release timelines, and throughput volume need to be updated or replaced to lower COGS. By automating QC methods and shifting to more rapid and less labor-intensive processes, we can enable a reduction in COGS and enhanced scalability.
Additionally, there is not always a strong understanding of the linkage between the cell therapy manufacturing process and biology. A better understanding of the therapy mode of action, the cell starting material, and the real-time process parameters are also critical for success.
As the field identifies more correlates of safety and efficacy from clinical studies, we must be poised to implement the appropriate engineering solutions in the CMC and manufacturing arenas to continue to drive efficiencies that impact COGS and product release cycles.
What technologies are needed to scale and reduce the cost of cell therapy?
Both allogeneic and autologous cell therapies have significant technological challenges in manufacturing and quality, which can facilitate a true and considerable reduction of COGS. There is a lack of large-scale fit-for-purpose downstream solutions for allogeneic therapies and a lack of closed, automated, and space-efficient manufacturing platforms for autologous therapies.
Faster and more reliable measurements such as rapid microbial methods, surrogate measurements of replication competency, and potency may help reduce the release testing cycle and lower the overall COGS.
Working with a partner with deep expertise in manufacturing cell therapies can be advantageous in this area. They understand and track (or even develop) solutions for these issues and can suggest and implement the latest and most informative technologies to maximize the chances of the therapy succeeding in the clinic and commercially.
Eytan Abraham, PhD, is the Vice President and Business Head for Resilience’s Cell Therapy, Gene Therapy, and the Nucleic Acid Franchises. Bruce Thompson, PhD, is the Vice President and Technical Head for the Cell Therapy Franchise at Resilience.
To learn about how Resilience’s cell therapy expertise can give your innovation its best destiny, contact the Resilience team today. resilience.com