MANUFACTURING OF INNOVATIVE THERAPY DRUGS: PROCESS OPTIMIZATION AND INDUSTRIALIZATION (ALL/AML)

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)