Gene therapy is a fast-growing sector in the life sciences industry, and there are countless reasons to be enthusiastic about it. For those living with diseases where other treatments have failed, gene therapies provide hope for a better life. One of the greatest challenges is how to scale up the manufacture of gene therapy products to industrial levels. For gene therapies to meet their potential, we need to solve this manufacturing challenge. Many gene therapy products are manufactured using individual steps that are both manual and involve open operations. Manufacturing efficiency is reduced, and the risk of product contamination increases.
Integrated manufacturing solutions create efficient, cost-effective manufacturing, irrespective of the in-house or contract development and manufacturing organization (CDMO) setting. Time, risks, and overall costs can be further reduced by adding single-use technologies to the closed systems. Gene therapies have the potential to revolutionize global healthcare treatments for diseases. Manufacturing and providing these therapies in an economically feasible way is still challenging. Companies must understand all manufacturing options available to them and select the one that best fits their product's process, scale, and manufacturing timelines. It is also important to consider whether manufacturing expertise will come from in-house employees or a supplier partnership, be outsourced, or involve a combination of these options. Fully understanding and optimizing manufacturing will enable more efficient and cost-effective production and ultimately will help advance patient access to the final product.
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