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 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.
