Ori Biotech selected to join cell and gene therapy process analytical technology consortium project

Ori Biotech Ltd., an innovator in cell and gene therapy (CGT) manufacturing technologies, today announces it has been selected to join the Process Analytical Technology Consortium Project. The consortium has been formed to increase process efficiency, consistency and quality and to lower the costs of cell and gene therapies by assessing the application and combination of multiple technologies for process analytics within CGT manufacturing.

The consortium is the largest to date in the global cell and gene therapy sector, in the number and specific expertise of the participating organizations, and its aims and objectives. In addition to Ori Biotech, it is comprised of over 20 pharmaceutical companies, therapeutic developers, raw material providers, technology providers, including sensor, manufacturing system and analytical tool companies, and charitable organizations. The consortium is led by the Cell and Gene Therapy Catapult, the organization established to advance the growth of the UK cell and gene therapy industry. The collaboration will be funded by the Cell and Gene Therapy Catapult itself as well as selective funding by either finance or materials from the consortium members.

The consortium has identified the development of process analytical technology as critical to the success of the cell and gene therapy industry. This technology will enable more full and detailed monitoring and control during the manufacturing process and the collection of data to be utilized in process development, characterization and optimization, as well as potentially predictive analytics and adaptive processing. It will ultimately lead to better process efficiency and reduce batch failures and manufacturing costs. This is a key element in accelerating the approval and commercialization of therapies across the cell and gene therapy sector. The consortium will assess multiple process analytical technologies, both newly developed for CGT and newly applied from other industries. These technologies will also be evaluated in specific manufacturing settings, in or alongside closed system processing and with specific CGT materials and equipment.

Ori has been asked to join the consortium for its expertise and specialism in CGT manufacturing and process data systems, its innovation in automation and intention to utilize the best analytical technologies to evolve the field.

Ori Biotech and the other member organizations will gain vital insight and knowledge through this collaboration and the sharing of the experimental data and conclusions on the suitability, applicability and value of these technologies to CGT development. They will be able to integrate this into the development of their product portfolios, whilst saving development time and sharing the costs of the research and development within the consortium. Ori will specifically benefit by adding to and complimenting its own investigation and development of process analytical technologies within its proprietary, flexible manufacturing platform for closing, automating and standardizing CGT manufacturing. Ori Biotech specifically developed its manufacturing platform to increase throughput, improve quality and decrease costs.

“Breaking down barriers within the cell and gene therapy field is vital for its ongoing commercial and therapeutic successes required to increase access for patients to next generation therapies. Process analytics is a significant component of the major manufacturing barrier that is preventing the commercialization of therapies for patients,” said Jason C. Foster, CEO, Ori Biotech. “To be selected to play a part in the Process Analytical Technology Consortium Project enables Ori Biotech to play a major role in a large consortium designed to break down some of these key barriers. The collaborations Ori will participate in within this consortium will enable us to both contribute our own expertise, but also acquire much of the knowledge and discoveries shared within the consortium. This will be essential to Ori as we continue to develop our own fully automated CGT manufacturing platform.”

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