Integrated Solutions To Support Gene Therapy Commercialization

Currently, there are thousands of global cell and gene therapy clinical trials underway, with an increasing proportion of candidates advancing to Phase III clinical evaluation. As momentum in the industry builds and the therapeutic success of cell and gene therapies continue to prove out in clinical trials, the global gene therapy market and investment in this space has likewise grown significantly. As a result, many companies are looking toward manufacturing and commercialization of their lead therapies. However, the path to commercialization for this relatively new modality is not well established, and there are still challenges in order to manufacture these products consistently, at the appropriate scale, and cost effectively.

Gene therapy commercialization focuses on managing and balancing risk during decision making. In the clinical, financial, and manufacturing domains, there are many choices to be made. Additionally, getting all of these to work together cohesively can be a significant challenge. Implementing integrated solutions can provide manufacturing systems that work in concert to create a closed, automated, scalable, and performance-qualified network of unit operations. Factors such as the product’s process, scale, automation needs, process economics, and manufacturing timelines, will be important in selecting a best-fit manufacturing solution.