UMSL is preparing to renovate dedicated lab space in the Research Building that will be used for its collaboration with API Innovation Center. (Photo by Derik Holtmann)
The API Innovation Center is a nonprofit organization dedicated to improving American health security by bolstering the supply of market-competitive, commercial U.S.-made active pharmaceutical ingredients, or APIs.
The center, based in St. Louis, aims to take advantage of advanced manufacturing technologies and innovative research to strengthen pharmaceutical development and supply chain resilience in the United States. It has partnered in those efforts with the University of Missouri–St. Louis and pharmaceutical manufacturers and suppliers of key starting materials, or KSMs, that form the initial chemical building blocks for synthesis processes.
Last week, APIIC announced it had been awarded $14 million in federal funding from the Department of Health and Human Services through the Administration for Strategic Preparedness and Response’s Center for Industrial Base Management and Supply Chain to lead the development and domestic production of three critical APIs used in the treatment of asthma, diabetes and anxiety disorders. APIIC is investing an additional $2.4 million in the development of those ingredients.
UMSL will play an important role in that work alongside partners Mallinckrodt Specialty Generics, Apertus Pharmaceuticals and MilliporeSigma. The university has strong research programs in chemical organic synthesis and advanced pharmaceutical manufacturing methods, including continuous flow technologies, and it also boasts strong industry partnerships.
“Partnering with the API Innovation Center on this important initiative allows us to leverage our strengths in research, workforce development and community engagement to support a more secure and self-reliant pharmaceutical supply chain,” said Chris Spilling, UMSL’s vice chancellor for research and economic and community development. “UMSL is proud to play a key role in advancing these critical efforts, which will have lasting impacts on both our region’s economy and the nation’s health security.”
More than 80% of the nation’s top 100 generic medicines have no U.S.-based source for the small-molecule APIs used in the medication, according to a 2021 study from the Olin School of Business at Washington University in St. Louis. Manufacturers depend on foreign producers to obtain those ingredients, and that makes the U.S. pharmaceutical supply chain vulnerable should there be shortages or geopolitical conflicts that leave domestic manufacturers operating below capacity.
The decrease in U.S.-based production of APIs and the KSMs needed to make them creates significant risk in national health security.
The investment by the Center for Industrial Base Management and Supply Chain is viewed as key to ongoing efforts to reshore critical medicines and alleviate drug shortages.
APIIC will lead the development and production of three critical APIs, which were selected because of their role in U.S. health care, history of shortages and presence on a list of essential medicines. They are albuterol, which is used in the treatment of asthma and other respiratory conditions; desmopressin acetate, which is used to treat diabetes insipidus and blood coagulation conditions; and lorazepam, which is used in treatments for anxiety.
“This funding represents both a financial commitment and a significant step towards securing America’s pharmaceutical resiliency and patient access to critical medicines,” APIIC Founder and Chair Tony Sardella said in a news release. “By focusing on developing these high-impact molecules, we are creating a private-public blueprint for driving self-reliance that is essential for national health security and can be replicated across the country.”
UMSL is preparing to renovate dedicated lab space in the Research Building that will be used for its collaboration with APIIC.
The state of Missouri and Missouri Technology Corporation have also been important contributors in helping APIIC develop a state-support model for creating a resilient national pharmaceutical manufacturing ecosystem center in the St. Louis region. To date, the state has committed approximately $18 million to API reshoring.
“Missouri is leading in restoring America’s pharmaceutical manufacturing strength,” Gov. Mike Parson said in a news release. “The state’s investment, now bolstered by federal support, is a clear indicator that what we are doing in Missouri is working. We are not just talking about solutions. We’re delivering results that are necessary steps toward safeguarding the health and security of our nation.”
