SAKARTA and Sinfonia Technology team up with MHRA to trial new stem cell manufacturing technology

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently trialling an innovative new robot that grows stem cells, called the CellQualiaTM Intelligent Cell Processing System.

Stem cells have a unique ability to turn into different types of cells with specialised functions, making them particularly useful in medicine for replacing damaged or lost cells from diseases.

However, stem cell-based therapeutics are difficult to manufacture, leading to limited availability of treatments that focus on limiting the extent of damage rather than fixing the damage that has already occurred.

The MHRA’s UK Stem Cell Bank is one of only two places in the world, outside of Japan where the robot was developed, to test this technology.

The 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 the Foundation for Biomedical Research and Innovation at Kobe (FBRI).

The robot has the potential to bring safer and more cost-effective treatments to people with a wide range of diseases, such as Parkinson’s.

The MHRA 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, stated that this technology could make the manufacturing process much easier, resulting in safer and more effective treatments.

The robot has the potential to reduce human error in the process and produce a more consistent final product. The results of the testing will be communicated to the public.

Health and Social Care Secretary Steve Barclay noted that the new robot has the potential to speed up access to more cost-effective and safer stem cell therapies.

The UK is only the second country where this technology has been tested, thanks to a partnership between the MHRA and industry.

The MHRA is responsible for regulating all medicines and medical devices in the UK, ensuring that they work and are acceptably safe.

SAKARTA Ltd is an exciting start-up building automated solutions for cell therapy and stem cell manufacture, while SINFONIA TECHNOLOGY Co., Ltd. is a company mainly engaged in the manufacture and sale of motion equipment and power electronics equipment.

The 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.


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