Periodic Reporting for period 4 - Lakhesys (Lakhesys: building the machine to make the medicines of tomorrow)
Reporting period: 2022-01-01 to 2023-02-28
The Lakhesys project aims at supporting the development and accessibility of innovative therapies called cell and gene therapies (CGT).
CGT have an incredible potential to save lives of patients suffering from incurable diseases such as genetic diseases and cancers.
For example CAR-T cells have been shown to cure patients suffering from certain relapsing leukemia for which there used to be no treatment in more than 50% of patients.
Unfortunately CGT such as CAR-T cells consume extraordinary amounts of ressources to make. This is in part due to the fact that they are made with the patients' own cells so that this living drug survives in the patient and watches and eliminates potential relapses. This is also due to the fact that they are advanced biotechnology products which need particular plants, equipments, reactants and skilled staff to be manufactured.
As a result these drugs cost typically 500 000€ to 2 000 000€ per patient and only a few thousand doses can be manufactured each year globally.
To save more lives without breaking the health systems we need solutions to massively produce these therapies in the best possible grade of quality and at an affordable costs. This is was the Lakhesys project is intending to do.
Lakhesys is an innovative instrument for cell and gene therapy manufacturing integrating the entire manufacturing process.
It is based on a network of individually programmable microfluidic bioprocessors allowing to perform the steps required to transform cells into medicines with higher precision and performances than conventional tools. By operating this network of bioprocessors Lakhesys offers a unique potential for screening and definition of optimal unit processes.
These processes defined at the scale of one bioprocessor can then be replicated consistently, always in Lakhesys, to adjust with desired production outputs.
With these features we expect Lakhesys to allow its user to accelerate their drug development project in the cell and gene therapy area and to considerably derisk the manufacturing scale-up. Lakhesys is also expected to considerably improve the economic performance of cell and gene therapy manufacturing, by above 75% for both capital expenditure and running costs required for treating the same number of patients per year.
CGT have an incredible potential to save lives of patients suffering from incurable diseases such as genetic diseases and cancers.
For example CAR-T cells have been shown to cure patients suffering from certain relapsing leukemia for which there used to be no treatment in more than 50% of patients.
Unfortunately CGT such as CAR-T cells consume extraordinary amounts of ressources to make. This is in part due to the fact that they are made with the patients' own cells so that this living drug survives in the patient and watches and eliminates potential relapses. This is also due to the fact that they are advanced biotechnology products which need particular plants, equipments, reactants and skilled staff to be manufactured.
As a result these drugs cost typically 500 000€ to 2 000 000€ per patient and only a few thousand doses can be manufactured each year globally.
To save more lives without breaking the health systems we need solutions to massively produce these therapies in the best possible grade of quality and at an affordable costs. This is was the Lakhesys project is intending to do.
Lakhesys is an innovative instrument for cell and gene therapy manufacturing integrating the entire manufacturing process.
It is based on a network of individually programmable microfluidic bioprocessors allowing to perform the steps required to transform cells into medicines with higher precision and performances than conventional tools. By operating this network of bioprocessors Lakhesys offers a unique potential for screening and definition of optimal unit processes.
These processes defined at the scale of one bioprocessor can then be replicated consistently, always in Lakhesys, to adjust with desired production outputs.
With these features we expect Lakhesys to allow its user to accelerate their drug development project in the cell and gene therapy area and to considerably derisk the manufacturing scale-up. Lakhesys is also expected to considerably improve the economic performance of cell and gene therapy manufacturing, by above 75% for both capital expenditure and running costs required for treating the same number of patients per year.
We have significantly advanced key technological developments as well as their integration in Lakhesys.
We have also significantly advanced multiple aspects of Lakhesys development and validation including those regarding its operating software.
We have been preparing Lakhesys product range industrialization according to our launch plan and increased our communications activities.
Lakhesys is closer to a stage where beta testing can be conducted.
We have also significantly advanced multiple aspects of Lakhesys development and validation including those regarding its operating software.
We have been preparing Lakhesys product range industrialization according to our launch plan and increased our communications activities.
Lakhesys is closer to a stage where beta testing can be conducted.
At this stage Lakhesys relies on six technologies which we consider to be highly innovative.
We expect to be able before the end of the project to demonstrate Lakhesys advantage for the manufacture of autologous cell and gene therapies such as CAR-T cells.
We aim at deploying Lakhesys to help the industry address the bottlenecks of cell and gene therapy manufacturing.
Our ambition is to help bringing manufacturing capabilities worldwide to hundred of thousands of doses of cell and gene therapies made per year while reducing costs in such a way that healthcare system be able to afford these innovative and potent therapies.
We expect to be able before the end of the project to demonstrate Lakhesys advantage for the manufacture of autologous cell and gene therapies such as CAR-T cells.
We aim at deploying Lakhesys to help the industry address the bottlenecks of cell and gene therapy manufacturing.
Our ambition is to help bringing manufacturing capabilities worldwide to hundred of thousands of doses of cell and gene therapies made per year while reducing costs in such a way that healthcare system be able to afford these innovative and potent therapies.