Drug substance

ABL Europe’s facilities in Strasbourg (4,500 m2) and Lyon (6,500 m2) are GMP licensed in accordance with the European Medicines Agency (EMA) for the manufacture of gene therapy products.

Both sites have large scale drug substance adherent and suspension capabilities, offering manufacturing & scheduling flexibility through all stages of clinical supply & commercialisation. 

Roller Bottles < 17 m2

Cell Stacks < 60 m2  (Cell Factories, CellSTACKs and HYPERStacks)

Stirred SUB 200 L and 500 L

Several drug substance suites provide grade A / B and grade A / C cleanroom classifications for the GMP manufacture of filterable and non-sterile filterable viral vectors types, compliant with regulations worldwide. 

Cell and virus banking can also be included in the scope of a complete product development program.

Process scale-up demonstration run activities are mitigated by using representative small scale equipment, throughout the process transfer, development, design and confirmation stages, with in-house analytical support provide by ABL’s QC department.