Genesys awarded grant to develop a cell and gene therapy manufacturing platform

Genesys Electronics Design is pleased to announce it has been awarded a $3 million grant by the Australian government to develop a microbioreactor for use in cell and gene therapy. With matched and in-kind funding from collaboration partners CSL and UNSW Sydney, Genesys will be the programme manager of a complex $9 million project over three years.

The announcement of Round 9 recipients of the Cooperative Research Centres Projects (CRC-P) Grants was made today by the Hon Karen Andrews MP.

Cell and gene therapy is a process where a patient’s stem cells or T cells are extracted from their blood, modified with therapeutic genes, and replaced. While the field is still in its infancy, the global excitement over the technology arises from the possibility of a cure for many cancers and genetic diseases in a single treatment. Already a few treatments have been approved by regulators for clinical use and many new treatments are being developed.

Titled Making cell & gene therapy affordable with a Microbioreactor, this CRC-P project will develop an automated microscale bioreactor to bring down the cost of genetically modifying cells for the treatment of cancers and inherited diseases.

Existing large-footprint machines require skilled staff and complicated multi-step procedures, resulting in prohibitively expensive treatment costs, limiting accessibility. For example, curing some cancers with CAR-T cells is possible but available only to relatively few, currently costing in the order of US$0.5 million per treatment.

Dr Robert Nordon and his team from UNSW’s Faculty of Engineering has developed microfluidic technology for miniaturising and simplifying the therapeutic cell manufacturing process, which aims to simplify procedures and significantly reduce cost. Genesys will commercialise the technology, establishing a new company to manufacture microbioreactors that can be used for both research and treatment purposes.

UNSW Deputy Vice-Chancellor (Acting) of Enterprise Professor Eliathamby Ambikairajah said: "It is exceptional partnerships like this that brings UNSW closer to our vision of improving quality of life for people in Australia and around the world.

“We are delighted to see our life-changing technology being recognised and translated into real-world impact. The grant is a testament to the extraordinary work being done throughout the University and in conjunction with our partners. UNSW looks forward to continuing the relationship with Genesys and CSL, and seeing the positive impacts the new platform will have on society.”

CSL will ensure the microbioreactor is focused on end-user needs and support the technology’s development. CSL is a global leader in biotechnology and one of the largest companies in Australia. Cell and gene therapy development is an area in which CSL is expanding its capabilities, having recently acquired a number of biotherapeutic technologies for the treatment of diseases such as sickle cell disease and β-thalassemia.

Dr Anthony Stowers, Senior Vice President Recombinant Product Development at CSL, welcomed the grant saying ”gene therapies hold great promise in providing lasting and even curative treatments for conditions that are currently incurable. However, as an emerging field, they are difficult and expensive to make. We are very pleased to be able to support this program by providing our expertise in cell biology and manufacturing in the hope that a fast, reliable and efficient instrument will be delivered to support better outcomes for people with serious medical conditions.”

This project supports the strategic priorities of Genesys, which has been to increase its focus on the development of high-reliability devices such as those used in medical industries. A few years ago, Genesys attained ISO 13485 certification for the design of active medical devices – those with software and electronics.

This new project will take the company beyond design to become a certified manufacturer of medical devices, being the “product sponsor” of the Microbioreactor. Genesys will offer contract device manufacturing services for companies that need a medical device but do not want to be the product sponsor.

While Genesys already has expertise in electronics and software development for medical devices, the grant funding will also enable Genesys to expand its capability into complementary fields such as blockchain technology and e-health systems integration within Good Manufacturing Practice environments.

The project is part of Genesys’ strategic plan to build stronger relationships with leading universities and become more active in collaborative research projects. Genesys plans to pursue opportunities to develop and manufacture other medical devices.

This project is strongly aligned with government priorities as set out by MTP Connect and the Advanced Manufacturing Growth Centre. The microbioreactor will enable treatments at the cutting edge of precision and regenerative medicine and help relieve the growing economic burden of supporting people with chronic health conditions. Advanced micro-manufacturing techniques will be required and the system will be enabled by Industry 4.0 principles.

For further information contact the Microbioreactor Project Programme Manager, Dr Tim Kannegieter on 0407 219 570 or timk@genesysdesign.com.au.