By George Todorov

Demand for cell and gene therapies is increasing, but are current manufacturing approaches up to the task? Technology companies are on the case and new solutions are emerging. Here, we explore the key considerations when developing ex vivo gene therapy and cell therapy processes for commercial manufacturing.

In recent years, ex vivo gene therapies have stirred hope for a curative treatment for B cell malignancies and, in the future, solid tumors. Somatic cell therapies have also been shown to be effective against metastatic prostate cancer and in hematopoietic or immunologic reconstitution therapies. 

CAR-T, CAR-NK, and T cell receptor (TCR)-T cell therapies are generated by administering recombinant genetic material that alters the properties of living cells. Genetic alteration of the cells is performed outside the body before the cells are delivered to the patient, so these therapies are classified as ex vivo gene therapies. In contrast, somatic cell therapies are human cells transplanted to repair damaged tissue or cells, and include modalities such as hematopoietic or mesenchymal stem cells and cellular immunotherapies.  

Both ex vivo gene therapies and somatic cell therapies have seen clinical success and commercial licensure. Cell immunotherapy products such as CreaVax RCC and Immuncell-LC have been licensed in South Korea since 2007. Dating back to the early 2010s, Dendreon’s Provenge was among the first somatic cell therapies to receive FDA and EMA approval. However, CAR-T cell therapies have taken longer to reach commercialization. Yescarta and Kymriah secured FDA approval in 2018, paving the way for others, such as Tecartus, Breyanzi, and Abecma. 

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