The STELLAR program is part of the development of the national bioproduction sector in regenerative medicine and more particularly in the field of human pluripotent stem cells.
It aims to give this sector a decisive competitive advantage by removing a major technological barrier through the development of an automated and standardized in-process quality control on adherent cells. Currently, only morphological observation of the cells or destructive controls can establish the level of differentiation of the cells. The production processes remain manual, very expensive and not industrially transposable, blocking the large-scale development of this type of production.
The objective of the STELLAR project is to develop and validate a continuous and non-invasive monitoring of pluripotent cell differentiation, allowing to control the differentiation of these cells according to a Quality By Design (QBD) principle. The goal is to introduce innovative technologies such as continuous holographic imaging, representative physical measurements of cell differentiation, and neural network learning of the system to enable prediction of the fate of a cell batch.
This project’s contribution will be:
- The reduction of production failures by anticipating the future of a batch: indeed, morphological monitoring is very dependent on the operator and requires long and specific training. The development of the solution will allow a standardization of the process and a sufficient initial training to intervene on several types of differentiations.
- Continuous and controlled large-scale production of differentiated cells. Thus, the development of quality control will allow a production scale compatible with a commercial phase.
- The elimination of destructive testing leads to a reduction in costs – a 50% reduction in in-process controls -, energy expenses and polluting waste. In addition to the preciousness and cost of raw materials, reagents and media, the development of the solution will save time and limit in-process quality controls, which generate polluting waste.
- The creation of a new tool for continuous monitoring of cell differentiation that will be useful in the more global field of regenerative medicine.
The stakes are therefore not only technological and economic, but also environmental and societal, by making these cell therapy or tissue engineering drugs accessible to the greatest number at a controlled cost.
Three French leaders in biomanufacturing are joining forces with Iprasense to break a major lock on the biomedical industry, respectively: CECS/I-Stem, EFS-Besançon and EFS-ABG.
CECS/I-Stem’s contribution consists of the collection of characteristic data and images at each stage of cell production and the development of an iPS reporter cell line for fluorescence.
Given the mastery of iPSC and hES keratinocyte production at I-Stem, this program was designed with this type of skin cells and is therefore in line with the projects of the Genodermatoses team.
This trial is financed by Banque Publique d’Investissement (BPI).