As a patient’s cells are collected, duplicated, and altered in the lab, cell and gene therapy is typically a time-consuming procedure that can take several weeks. Even more straightforward in vivo treatments need a number of stages, including the use of synthetic genetic components and artificial viruses. It is extremely challenging to manufacture any of them on a significant scale. It can be difficult, even in a research context when only tiny amounts of the aforementioned components are needed.
The Alliance for Regenerative reports that there are already more than 2,200 clinical trials assessing these medicines. However, the firm doesn’t seem to be discouraged by the intricacy of the manufacturing process. Given the amount of research, it stands to reason that cutting-edge technologies, apparatus, and concepts will be required in the very near future to enable the mass production of cell and gene therapies so that more patients may benefit from the novel treatments.
Undoubtedly, one of the biggest difficulties facing the production of cell and gene therapies at the moment is scalability. The fact that the manufacturing process frequently entails physical labor, which is time-consuming and expensive, is one of the primary problems in this industry. Because of this, it is now important to create therapies with reliable processes, explore the design space and comprehend biology on a small scale, and then scale up to production in low-impact systems that combine automated bioprocessing, integrated analytics, and connectivity to data management systems.
Given the intricacy of the procedure, cell and gene treatments are famously expensive to create. As a result, these treatments are becoming less scalable and accessible to patients. But thankfully, there are still initiatives to cut expenses. Although it is still difficult to produce autologous medications, businesses are building more facilities to save expenses. The major contributor to lowering the cost of producing cell and gene therapies is automation.
So that cell and gene therapies may someday be more widely available to patients and really benefit patients, it is imperative that the manufacturing process for cell and gene therapies undergoes significant advancements. It is envisaged that there would be enough of a drive as more and more cell and gene treatments are approved to create technologies that can enhance manufacturing and, by extension, commercialization.