MHRA trialling pioneering stem cell robot that could transform the availability of life-saving cell therapies
The MHRA’s UK Stem Cell Bank is one of only two places in the world to test this technology.
An innovative new robot that grows stem cells, the CellQualiaTM Intelligent Cell Processing System, is being trialled by the Medicines and Healthcare products Regulatory Agency (MHRA). This robotic system has the potential to bring safer and more cost-effective treatments to people with a wide range of diseases. It is currently the only one in the world outside of Japan, where it was developed.
Stem cells have a unique ability to turn into different types of cells with specialised functions. This makes them particularly useful in medicine because they can replace cells that have been damaged or lost from disease – for example restoring eyesight after corneal disease.
Because stem cell-based therapeutics are difficult to manufacture, their current availability is limited. This means that most treatments for degenerative diseases are focused on limiting the extent of damage rather than fixing the damage that has already occurred. The system being tested at the MHRA has the potential to change this, offering new hope to patients with serious diseases such as Parkinson’s.
This trial is part of a UK-based international research programme, launched in 2021, and a partnership between the MHRA, SAKARTA (a Scottish Regenerative Medicine start-up), and Sinfonia Technology Co. Ltd (a Tokyo-based electrical equipment manufacturer), supported by Foundation for Biomedical Research and Innovation at Kobe (FBRI). The UK Stem Cell Bank is testing the robot over a 12-month period to see whether the cells produced by the fully automated Intelligent Cell Processing System meet the standards needed for them to be used in the manufacture of potentially life-saving treatments.
Marc Bailey, MHRA Chief Scientific Officer said:
At the MHRA, we’re committed to being at the forefront of the latest scientific developments so that we can help bring safe and effective treatments to the people who need them most.
Cell-based therapeutics have the potential to treat, and even cure, a vast number of diseases but their availability has been limited because they are often very difficult to manufacture.
The new Intelligent Cell Processing System being tested at the MHRA, of which there are only two machines in use in the world, could make this manufacturing process much easier and therefore transform the availability of these treatments. It also has the potential to reduce human error in this process and produce a more consistent final product which will result in safer and more effective treatments.
We look forward to communicating the results of our testing.
Health and Social Care Secretary Steve Barclay said:
This pioneering new robot has the potential to speed up access to more cost-effective, safer stem cell therapies. By replacing cells that have been damaged or lost, this new technology could transform the lives of tens of thousands of people with Parkinson’s and other devastating diseases.
The UK is only the second country where this technology has been tested, thanks to a partnership between the MHRA and industry. It is yet another example of how clinical research is ensuring patients benefit from the very latest scientific breakthroughs.
Further information to help inform reporting
- The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK, by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- SAKARTA Ltd is an exciting start-up building automated solutions for cell therapy (and stem cell) manufacture. Together with key collaborators in Scotland and Japan, they are developing a robotic platform to deliver novel treatments for degenerative diseases.
- SINFONIA TECHNOLOGY Co., Ltd. is a company mainly engaged in the manufacture and sale of motion equipment and power electronics equipment. Founded in 1917, Sinfonia has a wide range of industrial equipment product line, from components for space rockets and aircraft, electromagnetic clutch brakes, to vacuum melting furnaces, power generators, handling equipment for semiconductor manufacturing devices. Sinfonia entered cell and gene therapy equipment market in Oct. 2021, with the launch of CellQualiaTM brand, and its first product, CellQualiaTM Intelligent Cell Processing System. CellQualia - INTELLIGENT CELL PROCESSING SYSTEM
- Foundation for Biomedical Research and Innovation at Kobe (FBRI) is a core support organisation in the Kobe Biomedical Innovation Cluster, which promotes industry-academia-government-medical collaboration. FBRI’s mission is to contribute to the creation of innovative medical technologies and the formation and development of medical-related industrial cluster through supporting R&D and clinical application that contribute to the realization of advanced medicine and building a next-generation medical system.