ABSTRACT

The scientific and technological achievements of the last decades have allowed the discovery and production of new biological medicines, or substitution of those previously extracted from animal sources, like insulin and growth hormone. Most of those medicines are proteins obtained by animal cell cultivation, which differs from bacteria and yeast in that animal cells carry out post-translational modifications needed for biological activity and similar to the natural protein. Biopharmaceutical production in mammalian cells, including hormones, monoclonal antibodies (mAbs), vaccines, and other molecules with medical interest, involves high cost processes due to factors such as:

• low cell yield • complex culture media • shear sensitivity • low resistance to toxic metabolites • complex purification • rigorous control of all phases • sophisticated methodologies of process control and final product

control.