Advanced Technology for Vector-Based Therapies Highlighting Stem Cell-Derived Exosomes Manufacturing Process

The number of clinical trials investigating viral vectors and MSC-EVs as therapeutic and skincare agents has been increasing greatly over the years. The complexity and fragility of the vector-based products, scalability, yield, and purity of production processes are challenges to meeting demand. With this comes the requirement to ensure that there are robust manufacturing processes in place to scale with demand and to make these therapies readily accessible to those who need them.

However, current manufacturing processes for vectors and exosomes have often been developed with limited scalability in mind and large shifts in technology must take place to enable industrialization. To overcome this challenge, we are presenting industrialization of an MSC-EVs case study which illustrates the next generation manufacturing process for large volume upstream manufacturing using high-quality hMSCs along with paired bioprocess medium formulations for cell growth and EV production and downstream clarification using tangential flow depth filtration (TFDF) system and highly efficient exosome concentration using tangential flow filtration (TFF) with hollow fibers. Parameters identified during the development phase of this study can be scalable to 2000 L bioreactor. For this case study, we will show the benefits of integrated manufacturing platforms for high-productivity and cost-effective exosome manufacturing to meet the increasing global demand.

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