Our integratorsIVETH integrator:IVETh is an expertise facility and the first industrial national integrator (labeled in 2022 by Secretariat General pour l’Investissement in the scope of Biotherapy and Bioproduction) entirely dedicated to the production, engineering and characterization of extracellular vesicles (EVs) for diagnosis and personalized therapies. IVETh gathers a unique in Europe park of advanced instruments (funded by Région IdF, UPCité, DRRT, ANR, France 2030) which includes all the instruments needed for the bioproduction of EVs (bioreactors 100mL – 1L, multiflasks), tangential flow filtration (TFF) systems and (ultra)centrifuges for EV purifications and a large panel of cutting-edge characterization instruments: a system for analytical separation (AF4 coupled with multiple detectors MALS/UV/FLUO/RI), Raman spectroscopy microscope and Raman tweezers microscope (biomolecular fingerprint at the bulk or single-EV level, respectively), NanoFCM for nanoflow cytometry (phenotyping + size & concentration), Nanosight (+ autosampler), Zetaview and Videodrop for NTA (size distribution and concentration), Super-resolution microscope, as well as different microscopy solution for potency testing. Magenta, ART-TG:The Accelerator of Technological Research in Genomic Therapy (ART-TG) is a public R&D laboratory created by Inserm to accelerate innovation in the field of cell and gene therapy. It has received the label « Integrator » since 2020 under the name of MAGENTA (Manufacturing Cell and Gene Therapy Advances) to support its preclinical and service activities with adequate environment and in the context of a quality management system. ART-TG regroups a team of experts in molecular and cellular biology or pharmaceutical sciences and is actively funded, being part of several networks including the EU IMI T2Evolve, TREM2Meds IEC, RHU IRIS, AFM/Telethon strategic Sickle Cell Disease GT Program, PEPR THERA-B consortium and Labex Vaccine Research Institute (VRI). ART-TG/MAGENTA offers a unique capacity to support translational research in cell and gene therapy for those using lentiviral vectors or CRISPR genome editing technologies. MAGENTA enables the development of processes for the production and control of lentiviral vectors, cell processing and gene editing including analytical methods. MAGENTA supports preclinical and IND-enabling studies from academic laboratories or start-ups, enabling access to early phase clinical trials. Equipments available in ART-TG/MAGENTA include Akta 600 and AktaPur chromatography systems, Krosflo TFF system, ultracentrifugation, Videodrop nanoparticle tracking analysis, multicolor flow cytometry, small and large-scale magnetic cell selection and automated cell culture (CliniMacs Prodigy system) and electroporation (Maxcyte) as well as ddPCR and a bioinformatic capacity to analyse lentiviral vectors genomic insertion sites. Standardized materials are available. Located in the Genopole of Evry south of Paris, MAGENTA is part of the Paris Saclay University, and of the Genother biocluster.
Meary center:Integrated within the largest university hospital in Europe (Assistance Publique – Hôpitaux de Paris, AP-HP), the MEARY Cell and Gene Therapy Center is the AP-HP manufacturing center for Advanced Therapy Medicinal Products (ATMPs). It offers all the latest services and skills in the fields of gene and cell therapy and tissue engineering. On a human scale, nestled in the heart of an ecosystem of healthcare and research structures, it is based on a dynamic of innovation that has led to several world firsts, and on privileged links with the medical and pharmaceutical sector. The MEARY Cell and Gene Therapy Center aims to produce, control and release batches of ATMPs for biomedical research. Biomanufacturing rely on state of the art equipment such as an automated cell manufacturing platform Prodigy®, a cell sorter Tyto®, in-house microbiological testing including endotoxin and mycoplams, expertise in development of functional tests… The MEARY Center has a: - GMP agreement from ANSM (French regulation agency), authorization n° TIE/19/O/001 (EUDRA GMP Certificate) for experimental ATMP manufacturing (production and quality control). - GMO agreement n°5691 from MESRI (French Ministry for Research). - It is FDA and AIFA approved for clinical trials.
The MEARY Center team has expertise and skills in the various aspects related to ATMP manufacturing and quality control. The Center already put in place cell and gene therapy clinical trials and partnerships with both academic teams and private companies. The MEARY Center is labeled "Intégrateur Industriel", and member of 2 Carnot Institute. |
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