By Brian Hampson, Vice President of Global Manufacturing Sciences and Technology, PCT
Patient-specific cell therapies (PSCTs—those in which cells extracted from the patient or a donor matched to the patient are processed and then returned as therapy to the patient) are still, in many ways, the new kid on the block in medicine; researchers, therapeutic developers, manufacturers, FDA, and payers are still exploring and developing an understanding of the powerful benefits and unique challenges of this growing industry. As we all become more familiar, an evolution will need to occur—as it had to for automobiles, computers, and every technological advance in human history—in order for these therapies to become widely adopted, cost-efficient, market-scalable, and sustainable over the long-term. We must seek to understand what is needed from a manufacturing perspective for us to achieve the future of patient-specific cell therapy.
In light of these challenges, it is crucial for cell therapy developers to invest in a robust manufacturing process that leads to products of high quality, at a reasonable cost of goods (COGs), that is scalable and sustainable throughout the commercial life of the product. This strategy—planning for and implementing a manufacturing process that from the beginning takes into account quality, COGs, salability, and sustainability—is something we refer to as Development by Design (DbD). DbD calls for planning for these four elements well ahead of the realization of each.
To achieve optimal DbD-based manufacturing, the industry needs not only manufacturing processes that are vastly different from the traditional methods of manufacturing biologics, but also from the current standard of cell therapy manufacturing. In order for the cell therapy industry as a whole to become commercially viable in the long-term, we must envision and develop the “factory of the future,” likely to have at least some of the following attributes:
- Manufacturing processes in controlled, non-classified (CNC) spaces
- Concurrent adjacent processing of patient lots
- A highly mitigated risk of human error
- An electronic execution system with release by exception
- A highly mitigated cost impact of idle capacity
- A minimal set of unit operations to execute the process
- A very low failure-to-deliver-therapy rate
- A robust, secure, supply chain
What we need is an industry-wide effort of innovation and engineering, an effort that is just beginning to take root at commercialization-focused cell therapy developers, as well as at some of the tools and technology providers and contract manufacturing partners that support developers. This will enable thoughtful and staged rebuilding of unit operations for cell therapy manufacturing from the ground up, to transform cell therapy manufacturing processes and test methods in a way that achieves true scalability and sustainability. Cell therapy manufacturing must move largely away from the clean room model and sent to the “back of the facility,” into production spaces more suited to high-volume production. That is not to say that clean rooms have no place in cell therapy; they certainly do. However, any time that automation, integration, and closed processing systems can result in steps whereby one entire processing room can be leveraged over a greater number of processes at any one time and with simpler facility infrastructure, your bottom line will be in better shape for the effort. Only by achieving this can we move together toward a world in which transformative cell-based therapeutics are accessible to all.
Brian Hampson is Vice President, Global Manufacturing Sciences and Technology, tasked with leading PCT’s newly created Innovation and Engineering department (I&E). I&E was created to help PCT’s Clients think beyond current practices and to develop long-term solutions to the unique challenges faced by the manufacturers of cell therapy products. PCT’s E&I solutions accelerate the use of automation, integration, closed processing and other strategies to address the important issues of scale up, cost of goods, quality control and robustness of our Client’s manufacturing processes in anticipation of commercial success.