Revolutionising cell and gene therapy manufacturing
Cell and gene therapies (CGT) represent a significant breakthrough in the treatment of patients suffering from cancer and rare diseases. Ori Biotech, a London and Philadelphia-based innovator in cell and gene therapy manufacturing, is on a mission to enable patient access to this new generation of life saving treatments. Ori’s platform technology has the potential to enable the production of cell and gene therapies at market scale, for market relevant cost, making it possible for patients to get access to high quality, affordable cell therapies earlier in the treatment pathway. As Ori’s design and development partner, PA Consulting is accelerating product development towards launch, utilising our broad range of scientific, engineering, manufacturing and design expertise, and by locating development work at our Global Innovation and Technology Centre in Cambridge, UK.
- Solved the critical technical challenges of reducing a large footprint, expensive, complex, manual process, into a compact, automated, benchtop cell processing system
- Designed a blueprint for large scale production to help cell and gene therapies to reach all patients in need
- Used our life sciences and innovation expertise to help Ori develop their intellectual property (IP) position and prepare to commercialise their breakthrough technology
Realising the potential of cell therapy
Currently, there are over 1000 ongoing clinical trials exploring different aspects of the efficacy and safety of cell and gene therapies, but only a few have so far been approved – like Kymriah® (Novartis), Yescarta® (Gilead), and Zynteglo® (Bluebird). Due to their expensive and labour-intensive manufacturing process, these drugs are currently amongst the most expensive therapies on the market, carrying price tags between $500,000 – $2 million per patient. The high prices are putting considerable strain on payers and healthcare systems.
Ori is developing a proprietary, flexible manufacturing platform that closes, automates and standardises manufacturing, allowing therapeutics developers to further develop and bring their products from pre-clinical process development directly through to commercial scale manufacturing. The initial focus of the platform is on supporting cell therapies (like CAR-T), though the flexible platform has the capability to support a wide range of processes. Chimeric Antigen Receptor (CAR) T cell therapy is a cellular therapy based on the genetic modification and re-direction of a patient’s T cells in order to specifically target cancerous tumour cells.
Turning the vision into reality
We’ve been working together with Ori to design, develop and build the technology for research laboratories and therapeutics partners to test. We’re also supporting Ori in shaping their future vision to ensure that we are designing a fully automatable system from the outset, scaling directly from a unit of one to a high throughput system capable of producing thousands of therapies a year.
It’s meant bringing together a diverse team of experts at our Global Innovation and Technology Centre in Cambridge, including:
- biochemists and biologists to anchor the work in the science of cell therapy and process development
- mechanical engineers, physicists and materials specialists to overcome complex engineering challenges
- software, electronics and quality experts to make sure the product satisfies stringent regulations and manage the software development and data integration
- product designers and automation experts to understand how users will interact with the system and house all the functions in a form that’s usable, small and scalable, and to visualise the product for investors and partners
- market sector specialists, experts in technology innovation and commercialisation in the life science sector.
With our support, Ori is moving towards product launch at pace. Ori aim to launch their first commercial product in early 2022 and scale towards a high throughput, fully automated commercial manufacturing system within three years post-launch.
We partnered with PA Consulting because they had the broad range of expertise we needed, from science to engineering to design to robotics and automation. We need to develop our technology at pace, because time is of the essence for patients with cancer and rare diseases. PA has delivered what we’d hoped for through the early stages of our partnership.Dr. Farlan VeraitchOri Biotech Co-Founder and CSO
We’re delighted to work with the Ori Biotech team on a project that is set to bring real benefits to patients. Realising a truly innovative idea in the market is not easy and requires vision, commercial expertise and technical capabilities. The passion and commitment Ori Biotech has demonstrated is a precious thing. Our multidisciplinary team recognises this and feels very privileged to be part of their mission to enable patient access to life saving treatments.Dr. Simon BurnellPA Consulting, Life Sciences Expert
Original Article: paconsulting.com