Biomaterials
Some believe that cellular creation violates the sanctity of nature, commoditises life and amounts to playing God.
A hard cell $37bn Markets and Markets 5,000 National Library of Medicine 112
The amount the synthetic biology (inclusive of synthetic cells) market is expected to grow to by 2027.
The amount, in expert years, that researchers in 2017 estimated it would take, to engineer a living cell configured from entirely artificial components.
All the same, Schwille is unsure how quickly this breakthrough might be used in actual medical treatment. Given her research into the smallest unit of life, she understands how difficult it is to know and control which external environmental factors ultimately impact artificial cells. That’s critical if a synthetic cell were to be used for delivering drugs into a patient when responding to a specific trigger. “We need to see what’s actually going on in such a cell system before it can be put into patients,” she stresses. “You have to know what is happening under controlled conditions and we could say this research is a step further away from synthetic cells which have been created before.” No less crucial, Schwille notes that needing water to exist could prove challenging. So far, these artificial cells can’t survive without it. At the same time, Schwille highlights how difficult it can be to control or wholly understand the mechanics of a synthetic cell. Her own research, which looks at the fundamentals of life itself, involves artificially building cells or parts of cells (vesicles, cytoskeletons, membranes) and looking at how they interact with inputs to divide and create new life. “It can be a headache to work with reconstituted proteins,” she admits, referencing one way of synthetically recreating a cytoskeleton. “And it is difficult to measure in a controlled setting the features of the biological molecules [we create].” Of course, these are problems researchers who are interested in creating synthetic cells for applicative use will also face. The German scientist is not the only expert
wary of getting ahead of themselves. For instance, a recent article from the Max Planck Institute of Molecular Cell Biology and Genetics concludes that, when it comes to artificial cells being able to
sense where they are in living tissue, hurdles remain. That’s crucial to be able to then deliver medicine or complete other tasks. “With [only] a handful of studies,” the article concluded, “it is difficult to explore the practical application of artificial cells fully.” Even if that milestone was reached, meanwhile, regulatory hurdles would also need to be surmounted. As it stands, US regulations for synthetic drug delivery systems do not yet exist – and the authorities would want guarantees over clinical trials and manufacturing safety. There may even be issues around how a synthetic cell would be classified. With regulations often created in a cautious manner, and on a case- by-case basis, moreover, EU guidelines on usage are some way off too. That’s even before getting onto the ethical dilemmas, notably around playing God or worries about not being able to control a synthetic cell. This isn’t to say that regulators are inactive. Over 50 countries have a bioeconomic strategy – inclusive of synthetic biology, including cells – as a way to drive innovation. That’s hardly surprising given bold claims on how cells could soon transform various corners of medical life. Though she’s doubtful of how soon the University of Carolina research might be put into action in a medical use, indeed, Schwille is mindful of just how dynamic synthetic cell research already is. “Even if we’re a far way from practical use in regenerative medicine,” she says, “there are so many applications being explored for synthetic cells right now.” For that to happen, though, it just might require stakeholders, from researchers to policymakers, to find a suitable and safe way forward together – moving synthetic life, and cells, from the world of sci-fi and into the real world of medical use. ●
Medical Device Developments /
www.nsmedicaldevices.com
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