Companies need to manufacture their product candidate under current Good Manufacturing Practice (cGMP) conditions in order to conduct clinical trials. R&D cost in bio-pharma is high and there is a need for more efficient technology as biologics manufacturing is complex and highly regulated by the FDA. Puneet Ramaul of Beroe Inc discusses the challenges encountered by bio-pharmaceutical companies in product development.
https://international-pharma.com/wp-content/uploads/2014/03/Why-the-need…pdf.pdf