MANUFACTURING OF ADVANCED THERAPY DRUGS: EARLY CLINICAL TRIALS OF CAR-T CELLS (ALL/AML)
- Biomanufacturing
- ALL
- AML
- Gene therapy
- Cell therapy
- CAR-T cells
- Clinical research (TRL 6-8)
GMP-compliant manufacturing of ATMP clinical batches for early cell and gene therapy trials.
AP-HP MEARY Center for Cell and Gene Therapy is a leader in the manufacturing of Advanced Therapy Medicinal Products (ATMPs), offering cutting-edge expertise to industrial partners to support and carry out their cell, tissue and gene therapy clinical trials. It supports industrial partners in the technical and regulatory development of their processes.
Description
Scope
Manufacturing of clinical batches of experimental drugs for advanced therapy:
- CAR-T cells
- Mesenchymal stromal cells
- Treg cells
- T progenitors
- Etc
Project management
Steps:
- Assessment of the project and its development stage
- Analysis of the manufacturing process and quality controls to be implemented
- Drafting of contracts and quality agreements
- Technology transfer
- Drafting of regulatory dossiers
- Trial set-up and batch manufacturing
Research infrastructure
- ATMPs Manufacturing Department: ATMPs manufacturing facilities (235 m2) encompass 6 ISO 4/5 clean rooms, with type 2 GMO containment
- ATMPs Quality Control Department: with its state-of-the-art equipment, the ATMPs quality control laboratory offers a wide range of control options, including control of raw materials, starting materials, reagents, intermediates and finished products
- Quality Assurance Department: regulatory support (technical-regulatory dossiers, clinical trial set-up) and quality management (GMP, audits, Pharmaceutical Quality Systems)
Quality assurance
- GMO approval n°5691 (French Ministry of Higher Education, Research and Innovation)
- ANSM authorization TIE/19/O/001 (Eudra GMP)
Specifications
The platform
A Cellular and Gene Therapy Center dedicated to the manufacturing of innovative therapeutic drugs:
- Pre-industrial development
- Clinical batch manufacturing (phases I-II)
- Regulatory support
- Setting up clinical trials
Supported projects
Experimental cell and gene therapy drugs for the early phases (phase I-II) of clinical development.
Examples of partnerships
Safety and efficacy of SMART101 in pediatric and adult Patients with hematological malignancies after T cell depleted allo-HSCT – The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with hematological malignancies."
Sponsor : Smart Immune
Terms
Projects are submitted to the MEARY Centre's Scientific Advisory Board for approval.
Contractualization may take the form of partnership/collaboration agreements, or service provision contracts.
OPALE entity
MEARY CIC-BT
Head of Entity
Contact
Dr. Sandrine PalcyBusiness Development Director