transfer the production process to new facilities with a fer-mentation scale of 41 L. The mAb-Racotumomab produced from bioreactors (Racotumomab-ST10L and Racotumomab-ST41L)have to be bioequivalent to ascites fluid-produced Racotumomab(Racotumomab-AF) in order to ensure the same effect in thepatients. The first bioequivalence study between Racotumomab-AF and Racotumomab-ST10L was reported by Machado and colleagues [10].