I’m delighted to report another significant step forward as we grow our bioinnovation capability and continue to extend our services at the overlap between biology and engineering. Cambridge Consultants has officially received our licence from the UK Human Tissue Authority (HTA) to store human tissue for research purposes. This opens the way to future development in cell therapies and regenerative medicine.
The HTA is a government body that regulates all work carried out in the UK that uses primary human tissues and cells – that is 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.
The primary mechanism to exert this control is through a licence system. 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.
Why is the licence important?
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.
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. But with this go-ahead to receive and handle primary human tissues at our Cambridge UK facilities, we can now develop and test cell-based processes under realistic conditions.
You might well say that this sounds unusual, given our reputation as a technology company. But this is an area we have moved into in recent years, after realising these new therapy approaches were moving out of research and into clinical use. 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.
As a company we have a long history of world-first engineering and technology development. We’ve built on this by adding biology skills and creating truly multidisciplinary teams under the ‘bioinnovation’ banner. Gaining our HTA licence is part of our journey to integrate biology into the company, extend our relevance to a new generation of clients and play our part in taking lifesaving new therapies from the research lab to the clinic.
Where do we go from here?
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.
We are already working with clients within our facilities to develop exciting new approaches for cell therapy manufacture. I expect our cell culture labs to be very busy in the coming months – so please email me if you’d like to discuss this growing area of our work.