MEARY

• Gene therapy
• Cell therapy
• Immunology

• Production of experimental advanced therapy medicinal products (EUDRA-GMP authorisation)
• Experience with several cell types: Mesenchymal Stromal Cells, CAR-T cells, Regulatory T-cells, Pro-T, cell banking, GMO management
• Overall regulatory control in experimental ITMs and sterile medicinal products (drug circuit, Good Manufacturing Practices (GMP), drafting of experimental medicinal product dossiers, etc.)
• Application and development of quality control tests
• Pharmaceutical Quality System
• Technology transfer, optimisation and industrialisation of processes from research to GMP production.

⇒ 235m2 of GMP-compliant production premises:

• • 5 production rooms (including 1 gene therapy room) with FFU or PSM to guarantee environmental class A in B.
  • Premises authorised for handling class 1 and 2 GMOs
  • CliniMACS Prodigy® Instrument (Miltenyi)
  • CliniMACS® Plus Instrument (Miltenyi)
  • MACSQuant® Tyto® Cell Sorter (Miltenyi)
  • VIA FreezeTM and VIA ThawTM (Cytiva)

⇒ 182m2 quality control laboratory :

• • NucleoCounter NC202 (Chemometec)
  • MQ10 Cytometer (Miltenyi)
  • Quant studio 5 PCR (Thermofisher)
  • Nanodrop One C spectrophotometer (Thermofisher), qNANO (Izon Science)

As part of the Assistance Publique-Hôpitaux de Paris, Europe’s leading university hospital centre, the MEARY Centre is a recognised pioneer in the production of experimental Innovative Therapy Medicines. Thanks to the players and experts working today to develop the medicine of tomorrow, it provides patients with innovative treatments at a controlled cost in compliance with Good Manufacturing Practice (GMP).

Objectives:

• To assist academic (clinicians, researchers) and industrial (start-ups and the pharmaceutical industry) players with the technical and regulatory set-up of their process to conduct a clinical trial.
• Provide proximity to clinicians and patients thanks to its direct location in a University Hospital Centre.

Missions:

• To produce and control batches of experimental ITMs as part of academic or industrial clinical trials.
• To provide expertise in optimising manufacturing processes to transition to GMP production.
• Provide regulatory expertise in setting up clinical trials involving investigational ITMs.

• EudraGMP certificate no. 2023-MTIEXP-001 (ANSM)
• Label Carnot Opale
• Carnot Label @APHP

Academics

• TRAUMACELL
  • Effects of intravenous administration of umbilical cord Wharton jelly-derived mesenchymal stromal cells on systemic immunomodulation and neuroinflammation after traumatic brain injury (EU CT N° 2023-504415-33-00) – Phase I/IIa – Pr Vincent Degos, Hôpital Pitié-Salpêtrière, Paris – AP-HP Promotion

• SCARR
  • Allogeneic Umbilical Cord Mesenchymal Stromal Cells for the treatment of chronic humoral rejection (cABMR) of kidney transplants (EU CT N°2023-506598-36-00) – Phase I/IIa – Pr Antoine Durrbach, Hôpital Henri Mondor, Paris – Promotion AP-HP

• DUALCALM101
  • Immunotherapy with CD19/CD22 CAR-T cells in patients with refractory acute leukaemia – Phase I/IIa – Pr Nicolas Boissel, Hôpital Saint-Louis – Promotion AP-HP

• TREG PROGRAM
  • Autologous regulatory T lymphocytes in the prevention of hepatic, pulmonary and renal transplant rejection (TH-Treg, TP-Treg and TR-Treg) – Pr Makoto Miyara, Hôpital Pitié-Salpétrière, Paris – AP-HP Promotion

Industrials

• SMART101
  • Production of SMART101, developed by Smart Immune, as part of two phase I/II clinical trials (NCT04959903 and NCT05768035). These international trials (in Europe and the United States) are evaluating the safety and efficacy of SMART101 in accelerating immune reconstitution to combat infections and relapse after haematopoietic stem cell allotransplantation.