All bioproducts heading to commercialization go through a rigorous process that includes research and development, proof of concept, and validation studies. Furthermore, the fabrication process of a biological product is very different from that of a classical (synthetic small-molecule) pharmaceutical. That’s not only because of specific characteristics and requirements of the molecular entities involved, but also environmental considerations and specific issues related to human health and safety. Such differences are reflected in the cost drivers of approved manufacturing plants. Herein…