Institute expects improved standards to reduce costs and need to outsource production work.
FDA has awarded the nonprofit National Institute for Pharmaceutical Technology and Education (NIPTE) $35 million over the next five years to develop approaches to reforming and improving drug manufacturing standards. The institute maintains that investment in manufacturing will aid competitiveness in the U.S., and help reverse the current trend toward outsourcing from abroad.
“Outsourcing of drugs and drug intermediates are increasing at an alarming rate, potentially threatening overall quality of our drugs,” comments NIPTE executive director, Prabir Basu. “Development and manufacturing costs can be reduced, quality of our drugs can be improved, and outsourcing trends can be reversed by developing science-based standards for drug developing and manufacturing.”
To this end, the FDA grant will support NIPTE programs aimed at rectifying existing drug development and manufacturing problems by generating new ways to reduce time to market, improve small-batch production, promote continuous manufacturing, save money/energy, and reduce the environmental impact of manufacturing. “Over the last several years, NIPTE has contributed a great deal of research toward our understanding of quality pharmaceutical manufacturing,” remarks Helen N. Winkle, director of FDA’s Office of Pharmaceutical Sciences. “Progress in this area will mean safe, more efficient, and less costly drug production here in the U.S.”