Lindsey Clarke
Lindsey Clarke, head of cell and gene therapy EMEA at Bio-Techne

On January 21, 2020, three companies—Bio-Techne, Fresenius Kabi, and Wilson Wolf—announced a joint venture in cell and gene therapy. As Lindsey Clarke, head of cell and gene therapy EMEA at Bio-Techne, said, “We have a great portfolio of tools that are being used to make these therapies already, but by partnering we combine complementary expertise and together we can develop truly scalable manufacturing technologies and processes.”

Although cell and gene therapies are showing great potential for a range of diseases, current manufacturing processes create a bottleneck in the ability to scale. Companies face many challenges in developing cell and gene therapies. “For autologous therapies,” Clarke explained, “it’s such an incredibly complex supply chain.” Cells are taken from a patient; the cells are engineered as needed and then returned to the patient. Consequently, the clinic, manufacturer, and logistics must be tightly aligned “to scale this out,” Clarke said. “So, manufacturing really needs to be streamlined.”

Making manufacturing platforms that simplify the production of cell and gene therapies will be even more important as this market grows. One market report forecasts almost a 37% increase from 2019–2025. To keep the tools advancing that fast, the industry might need to rely on collaborations.

Bio-Techne is already planning for this increasing scale and demand. The company announced significant investment in its GMP manufacturing operations, and it just entered another partnership around using its expertise to scale up COVID serological testing.

“Cell and gene therapies show so much potential,” Clarke said. “As an industry, we know that collaboration is going to be key to solving the many challenges of scale.”

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