Toulouse, La Madeleine, Nancy, France – 28 February, 2022
The OPTI-STEM consortium led by CDMO Cell-Easy receives €7M from the French government and Bpifrance and €800,000 from the Occitanie Region to democratize access to cell therapy in France and Europe
The OPTI-STEM project aims to optimize the production of MSCs in order to democratize access to them and thus allow the diversification of therapeutic applications of this type of cells and their derivatives (exosomes, etc.). To achieve this objective, the R&D consortium led by Cell-Easy has obtained public funding of more than 7 million euros as part of the “Biotherapies and Bioproduction of Innovative Therapies” acceleration strategy, operated on behalf of the French government by Bpifrance.
The development of innovative therapies based on mesenchymal stem cells (MSCs) is confronted with prohibitive production costs, limiting patient accessibility and discouraging reimbursement agencies in a context of budgetary constraints in many countries. The dilemma is important: deny innovation to millions of patients or develop a multi-speed elitist medicine. A significant improvement can only be achieved by a complete overhaul of these processes. The OPTI-STEM project, funded by the French government to the tune of 7 million euros, proposes to transpose to the production of MSCs for therapeutic purposes the systems biology methodology that has been successfully applied to microbial bioproduction, while integrating new components of non-animal origin into the culture media. Beyond the change of scale, it is also the management of the production parameters that will be improved thanks to the development of micro-sensors with “intelligent” monitoring.
OPTI-STEM aims to combine large-scale MSC production with on-board analytical monitoring. The goal is to monitor and control the industrialization of the production of large quantities of MSCs to facilitate therapeutic applications, reduce prices by a factor of 100 and reach a production capacity of more than 100,000 doses per year.
Upstream of the Opti-Stem2 project and in a complementary way, the funding from the Occitanie Region will allow the development of the preliminary phases of the process (2D and/or 3D), as well as the precise analytical characterization of the MSCs produced at 3 levels: their identity (Cellnature®), their safety (Cellsecure®) and their therapeutic effectiveness (Cellfeature®).
Cell-Easy is a Young Innovative Company whose mission is to develop the production of stem cells on an industrial scale with the ambition to democratize access to them, by facilitating the implementation of numerous clinical trials in various fields of application, opening the way to new treatments for a greater number of patients in need, in particular for pathologies that currently have no therapeutic solution (critical ischemia of the lower limb, for example). As an indication, the current cost of a single dose of one of the few products currently on the market is €54,000.
The global approach of systems biology, directly inspired by the approach that has allowed the optimization of many microbial cultures, will lead to the removal of the empiricism that is still required in the field of cell cultures. This observation led Cell-Easy to join a panel of partners – the Roquette Frères company, the RESTORE, TOXALIM, LAAS and LRGP-MTInov laboratories – mastering the production of innovative ingredients of vegetable origin, the knowledge of physiology metabolism and characterization of the properties of adipose tissue MSCs (ASC), the development of miniaturized sensors, the identification and modeling of metabolic pathways by bioinformatics analysis of metabolomics data and the culture of stem cells in 2D flasks.
This set of industrial and scientific skills perfectly complements the know-how developed by Cell-Easy for the production of MSCs and will allow a qualitative and quantitative leap in the mastery of the industrial production of this type of cells, which is essential both to succeed in a significant change of scale and to efficiently meet the quality, safety and efficacy constraints imposed by the regulatory agencies.
The consortium will conduct an original multidisciplinary approach around the following 5 axes:
- Adequacy between culture conditions and cell phenotype (RESTORE, TOXALIM, Cell-Easy)
- Definition of culture and conservation media (RESTORE, Cell-Easy, Roquette)
- Quality control of cell productions (RESTORE, LAAS, Cell-Easy)
- Development of tools for real-time monitoring of MSC cultures in bioreactors (LRGP, LAAS, Cell-Easy)
- Data integration (RESTORE, TOXALIM, Cell-Easy)
The joint financing of this new process by the State and the Occitanie Region will strengthen the development of the bioproduction of innovative therapy drugs (ITD) in France, and more particularly will contribute to facilitate the emergence of new therapeutic applications of mesenchymal stem cells over the next decade.
About Cell-Easy – www.cell-easy.com
Founded in 2017 in France, Cell-Easy is a company specialized in the development and custom production (CDMO) of cells and their secretome for cell and gene therapies, whose objective is to provide easy and rapid access to ready-to-inject allogeneic therapeutic solutions for clinical treatment development projects.
About ROQUETTE Frères – www.roquette.com
“Offering the best of nature”. Roquette is a world leader in plant-based ingredients, a pioneer in plant proteins and a major supplier of pharmaceutical excipients. The group responds to the societal challenges of today and tomorrow by revealing the potential of nature to offer the best ingredients to the food, nutrition and health markets. Driven by a desire for permanent innovation and a long-term vision, the group is committed to improving the well-being of millions of people throughout the world while taking care of resources and territories. Founded in 1933, Roquette is a family-owned company with a presence in more than 100 countries, a turnover of approximately 3.5 billion euros and 8,360 employees worldwide.
About RESTORE CNRS – www.restore-lab.fr
The challenge of RESTORE is to bring together research teams in a wide variety of fields ranging from mathematics, physics, chemistry and biology to the bedside. This unique transdisciplinary research center is dedicated to a global exploration of the origin of age-related physiological alterations in order to propose innovative applications in the field of geosciences, rejuvenation and biotherapies. RESTORE brings together young and talented researchers from these different fields and develops efficient technological approaches accessible to the academic or industrial scientific community. Involvement in the CARe University Research School (https://care-graduateschool.fr) also allows us to offer students a unique international transdisciplinary master’s degree program.
About TOXALIM INRAE – www6.toulouse.inrae.fr/toxalim
The joint research unit in food toxicology, TOXALIM (INRAE-ENVT-UT3), contributes to the development of knowledge on the long-term effects on human and animal health of toxic compounds such as agricultural inputs, pesticides, mycotoxins, packaging migrates and other food contaminants. Within the unit, the Metabolism and Xenobiotics (MeX) team has a strong expertise in the development of in silico models of the metabolic network of human cells in order to identify cellular metabolic modulations induced by low doses of endocrine disruptors, but also more broadly to study cellular metabolic modulations in different genetic and environmental contexts.
About the LAAS CNRS – www.laas.fr
With more than 650 people, the CNRS Laboratory of Analysis and Architecture of Systems is one of the most important research units of the organization. To anticipate the major interdisciplinary challenges of our rapidly changing society, the LAAS-CNRS has identified strategic axes based on the four major disciplinary fields that have been the hallmark of the laboratory since its creation in 1968: automation, robotics, computer science, and micro and nanotechnologies. Within the MNBT (Micro and Nano Biotechnologies) department, the ELiA (Engineering in Life Sciences and Applications) team has a strong expertise in the development of technologies for the design, fabrication and characterization of microfluidic devices and 3D in-vitro models applied to tissue engineering.
About the LRGP CNRS – www.lrgp-nancy.cnrs.fr
The LRGP (Laboratoire Réactions et Génie des Procédés, UMR 7274) is a joint unit of the CNRS and the University of Lorraine created on January 1, 2010 and based in Nancy. The team will provide the OPTISTEM project with its expertise in the development of human cell culture processes in bioreactors, in particular the culture of MSC on microcarriers.
The industrial integrator MTInov was born in 2020 from the association of the Cell Therapy and Tissue Bank Unit of the Nancy CHRU and the Bioprocesses and Biomolecules research axis of the Reactions and Process Engineering Laboratory (CNRS, UL). This platform for the study, optimization and scaling up of the production of biomedicines based on human and animal cells, has expertise in cell culture in stirred bioreactors (on-line monitoring, intensification, modeling and design of bioreactors), as well as in the transfer to clinical grade in compliance with good manufacturing practices.