Cambridge Consultants kicks on with human tissue licence for bioinnovation

Cambridge Consultants accelerated its bioinnovation capabilities this month following a successful application for a licence from the UK Human Tissue Authority (HTA) to store human tissue for research purposes.

The HTA is a government body that regulates all work carried out in the UK involving primary human tissues and cells – human material obtained from donors. Its job is to ensure all samples are obtained ethically and with consent, and that the material is used respectfully and safely by competent people for appropriate reasons. Anyone who wants to work with primary human tissues and cells in the UK is legally obliged to obtain a licence and be on a register: this includes hospitals, research groups and biotechnology companies.

A Cambridge Consultants spokesperson said: “Obtaining the licence is a vital boost to our increasing work in cell therapies and regenerative medicine – particularly scale-up and manufacture. These next-generation therapies rely on handling and manipulating human cells outside the body.”

Richard Hammond is technology director and head of bioinnovation at the Science Park-based company.

“There are 160 people in the medtech group,” he explains. “There’s ten of us in the core bioinnovation team, for clients who need engineering and biology skills. We started the group five years ago to extend our range of capabilities, so we have labs on the Science Park and we’re building that capability.”

Acquiring the licence is a statement of intent too. Cambridge Consultants is best known as a world-leading engineering and technology company. Then biology was added to the mix, and that has evolved into multidisciplinary teams under the ‘bioinnovation’ banner.

“As we investigated further, we started to understand the scale and depth of the technical challenge involved, and how good solutions require deep understanding in both biology and engineering,” says Richard, adding: “Holding this licence is not trivial. The application process took six months and many hours of effort to define all our procedures and protocols to meet the HTA requirements. Our application was assessed in depth before the licence was issued.

“As part of our procedures we have created an HTA panel that sits quarterly to oversee our work and ensure we maintain the highest standards of ethics and safety. We are audited by the HTA annually to check compliance and we are obliged to display our licence so everyone can see we have it. This opens the way to future development in cell therapies and regenerative medicine.”

Obtaining the licence is far from a shoo-in.

“It costs £3,000 a year to maintain, and it takes a lot of effort to acquire it, to demonstrate to the authority that you’ll handle the material safely.

“Cell lines are one thing but if you want to use primary new materials that’s a whole new level of control. You can’t just have patient samples sitting in freezers, so it’s about how to store, acquire and dispose the material. A big part is traceability, so how many samples, when they were used, how they were stored. Plus there are ethical considerations, you don’t hold human material lightly. You have to get consent, but also the donor might not want them [the cells] to be used for some purposes, for instance if there are religious beliefs involved.

“We’re pushing into some quite new areas, with new challenges and technical problems in the medical industry.”

The licence legitimises Cambridge Consultants’ push into synthetic biology by expanding the sort of projects that can be taken on. While cell lines are usable up to a point for process development and characterisation, ultimately you can only gain confidence in your process by testing on human cells with all the associated heterogeneity. And, with this go-ahead to receive and handle primary human tissues, Cambridge Consultants can now develop and test cell-based processes under realistic conditions at its new extension on the Science Park.

“These are next-generation so you start with small molecules, then it’s monoclonal antibodies but cell therapies are the very newest – where you use modifying cells to fight a disease, typically cancer, so it’s immune cells. So you take the cells from a living person, manipulate the cells, then put them back into the person. It’s a non-trivial process.”

The bioinnovation team at Cambridge Consultants signed off 30 contracts in 2020, “typically most last for between six and nine months”.

The track record is good, says Richard, who studied engineering at the University of Cambridge and was working at Red Bull until he joined Cambridge Consultants in 2015, saying: “After a few years sending people round a circle at high speed loses its appeal.”

“We haven’t had a client yet where we haven’t been able to deliver a successful result,” Richard concludes of Cambridge Consultants’ bioinnovation initiative. “It does happen but so far, for us in bioinnovation, we’ve managed to find a way through in all instances.

“We are already working with clients within our facilities to develop exciting new approaches for cell therapy manufacture.”