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A new university spinout company is hoping to use synthetic biology to transform gene therapy manufacture. SynGenSys, from the University of Sheffield, plans to tap into engineering design principles to create synthetic promoters to target therapeutic genes to the correct patient tissues.

“Typically, people use viral promoters, such as cytomegalovirus as their go-to promoter, but it’s a really complex piece of DNA active in many human tissues,” says David C. James, PhD, professor of bioprocess engineering and co-founder of SynGenSys.

The company aims to rely on engineering principles to create a library of genetic building blocks. These can be used, James argues, to engineer mammalian cells with, for example, high levels of gene expression, or with expression limited to a target tissue.

“We think, in the future, genetic engineering using synthetic genetic parts with predictable, user-defined activity—such as tissue specificity—is a fundamentally safer way to give advanced medicines,” he explains.

James argues their approach is a fundamentally new way to approach cell factory engineering, which traditionally relies on high-volume screening of clonal cells. The traditional approach, he says, is coming under pressure as products become increasingly complex.

“Companies can be developing single-chain fusion proteins, traditional monoclonal antibodies, or bi/tri-specific molecular architectures, and they’ll use basically the same expression system for each, and then rely on clone screening to identify a cell line for manufacturing,” he adds.

“It’s akin to using the same tooling to make a bus and a car. One of our underpinning themes is designing expression systems to suit the product.”

The company’s long-term goal is for genetic engineering to apply the principles of product line engineering, with a core set of genetic parts swiftly deployed to meet new applications.

“To draw an analogy,” he says. “If you go to select a new car, you can go to the showroom and expect to choose upholstery or color. To achieve this, car manufacturers have to adapt their production processes to accommodate customer specifications—product line engineering.”

SynGenSys already has off-the-shelf products and a major biopharmaceutical investor. According to James, he feels his marketing effort is pushing at an open door, with companies too often focused on process optimization.

“You need to change how you work,” he says. “And this industry is too often conservative.”

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