• The production of lab-grown skin in a fully-closed system based on single use disposables was a big milestone, proving that CUTISS’s vision can become reality.
• This closed system can increase safety for both operators and patients and optimise the manufacturing facility space and maintenance whilst reducing costs.
• CUTISS and Zühlke are continuing their collaboration to scale-up denovoSkin™’s manufacturing process. This should provide new hope for patients requiring large amount of skin.

Today’s standard of care in skin surgery is split-thickness skin autografting. A thin layer of skin is harvested from a patient’s own donor site and applied on the wounds. Donor site shortage is an unmet need in large wounds and split-thickness skin autografting often results in permanent, highly debilitating scars.

The Swiss Life sciences start-up, CUTISS, wanted to revolutionise skin surgery by using personalised, bio-engineered skin that could improve patient’s quality of life by reducing scarring. CUTISS developed a process in which a personalised bilayer skin graft can be bio-engineered in the laboratory in large quantity starting from a postage stamp-sized skin sample. CUTISS developed a first-in-class automated process that collects keratinocytes and fibroblasts, expands them, and then uses them to create a skin tissue graft.

Currently, the biotechnological manufacturing process is carried out manually. Automating the process is a key step for the life sciences start-up. That’s why CUTISS and Zühlke started a collaboration in 2018.

Using agile methods and working in interdisciplinary teams, we analysed a range of factors and worked with CUTISS to develop a concept for a complete automated production process.

With CUTISS, we developed a functioning prototype for the first step of the manufacturing e.g. cell isolation. The prototype included a sterilised disposable set comprising tubing and bags. The proof of concept demonstrated that it is indeed possible to isolate single cells from a skin biopsy automatically and in a fully closed fashion – an important milestone for CUTISS.

Following an extensive test phase, we started working on developing the next generation cell isolation system. The system also included a new disposable set with a smart sample loading aid for which CUTISS and Zühlke were awarded the Swiss Plastics Expo 2023 Award for Engineering.

A key feature of lab-grown skin production automation is the fully closed system based on single use disposables. A closed system can increase safety for both patients and operators and optimise the manufacturing footprint and maintenance whilst reducing costs.

Today, Zühlke and CUTISS are continuing their collaboration.