Résumé
Background and AimsThe landscape of regenerative medicine and biotherapies is undergoing a transformative evolution, driven by the surging demand for scalable and standardized production of cutting-edge therapeutic agents. At the heart of this progress lies the Occitanie Biotherapy-Bioproduction Integrator (OBBI), a unique European pioneering structure functioning as a HUB with up-to-date facilities that brings together scientific and clinical expertise to address critical challenges in the development of biotherapies and the bioproduction of extracellular vesicles (EVs) and organoids.MethodologyBy providing our partners with access to expert academic resources, we develop robust and reproducible processes for producing EVs and organoids including rigorous GMP-like quality controls.ResultsAs an example, we set-up an innovative organoid process suitable to generate 3D microphysiological human beige adipose tissues of different scales (from 1 mm to 1 cm) without the use of Matrigel. These organoids present the classic architecture of native tissue, the metabolic and endocrine functions and are sensitive to key inducers of beige phenotype. The different sizes of organoids and micro-physiological tissues are compatible with the development of screening models as well as future transplantable Advanced Therapeutical Medicinal Product (ATMP) (1 and patents). In parallel, we implement a machine learning based pipeline of transcriptomic profile to rapidly identify key molecular markers and targets from single cell analysis.Furthermore, we are investigating the production of EVs from organoids as the reflect of tissue complexity. All these bioprocess and pipeline analysis can be easily translated to any other organoid and 3D objects.A comparable strategy for addressing the demand for bioassays and therapeutic agents across various fields is being implemented for EVs.ConclusionOBBI provides access to dedicated academic platforms and expertise that accelerate quality by design integrated bioproduction scheme to bridge the gap between research and industrial or clinical applications, ultimately revolutionizing patient care on a global scale.