Integrated Microfluidic Bioproduction
One Instrument capable of Producing any Cell or Gene Therapy in a fully Automated Way
Lakhesys is an integrated and versatile solution to improve, standardize and upscale CGT production.
Lakhesys instrument is an automated closed system that supports all key steps of CGT production. It is fully programmable, enabling the user to program the instrument for the manufacturing of any known cell or gene therapy.
Within Lakhesys, all operations are performed in a state-of-the-art microfluidic environment with optimal accuracy and efficiency.
The instrument is designed to support batch size upscaling, from research to clinical use, using the exact same manufacturing protocol.
Why we have chosen a Microfluidic Approach
Microfluidic is the science of handling liquids at very small scales. At Astraveus we have developed microfluidic based technologies specifically adapted for cell and gene therapy manufacturing purposes.
Using microfluidics we are capable of handling cells and reactants with high precision. This is key for the reproducibility of cell and gene therapy manufacturing protocols.
Our microfluidic approach also allows for loosing virtually no cells. Additionally, we are processing cells in miniaturized liquid volumes.
Thus, we make the most out of each cell and droplet of reactant, leading to unprecedented efficiency.
Our Approach to Overcome the Scaling Problem
Currently companies manufacturing cell and gene therapies re-engineer their protocols every time they have to increase batch size. This is because today, manufacturing instruments (e.g. bioreactors) of different capacities, cannot implement processes in a proportionate manner. As a result, re-engineering of the protocol is required as batch size increases, in order to obtain outputs of consistent quality. Protocol re-engineering demands screening to identify optimal production parameters. With increasing batch size up to a clinical dose level, the larger quantity of cells and reactants required for screening purposes make re-engineering expensive and challenging.
To tackle this problem, our approach was to develop Lakhesys, an instrument capable to scale production in proportionate and quality consistent manner without any need for re-engineering. This is attributable to Lakhesys ability to define and replicate a "unit process", i.e. a model process of constant attributes.
Defining the unit process is performed by process parameter screening the first time that a cell or gene therapy product is manufactured using Lakhesys.
Once the unit process for a cell or a gene therapy is defined, it is the basis for downstream manufacturing of batches of any size of the respective therapy. To make a batch, a number of parallel replications of the unit process are performed simultaneously within the same Lakhesys instrument. The number of replications directly depends on the ratio between the desired batch size and the unit process output size.
For further upscaling, an unlimited number of Lakhesys instruments can run in parallel to manufacture multiple batches simultaneously.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement N° 850358.
This project has also received funding from French Minister of Education and Innovation and BPI France as part of i-Lab 2018 program.