By Nathan Rubbelke, St. Louis Business Journal | October 14, 2021
The Cortex Innovation Community has launched a new initiative to strengthen the U.S. supply chain for pharmaceutical ingredients.
Its Active Pharmaceutical Ingredients (API) Innovation Center @ Cortex will enhance those efforts. The nonprofit API Innovation Center wants to "address health security and foster job growth” and will seek to advance that mission by having businesses, researchers, academics and experts work together to find ways in which the U.S. can boost production of pharmaceutical ingredients.
“The API Innovation Center at Cortex is dedicated to addressing the fragility in the U.S. API supply chain and the risks to health security. Missouri, as the number-one-ranked state in the country for production of pharmaceutical APIs, is uniquely positioned to help secure the domestic supply chain,” said Tony Sardella, chair of the API Innovation Center. "Promising advancements, such as continuous flow manufacturing technologies, offer the opportunity for the U.S. to address our health security risks. The center will steward the necessary collaborations for these innovative technologies to realize their full potential.”
Organizations currently involved in the API Innovation Center include Cortex, BioSTL, Mallinckrodt Specialty Generics, Continuity Pharma, AMIC and Apertus Pharmaceuticals.
The new initiative is the second innovation center launched this year by Cortex. In May, it established the Global Center for Cybersecurity @ Cortex, which collaborates globally within the cyber industry. Cortex President and CEO Sam Fiorello said Cortex is a natural fit for these types of projects given its ability to convene innovators across academia, business and government.
“This is what we do best,” Fiorello said.
The organizations behind the API Innovation Center said their collaboration targets a U.S. public health concern. A recent study from the Center for Analytics and Business Insights at Washington University’s Olin Business School found that more than 80% of the active pharmaceutical ingredients in medicines considered essential by the U.S. Food and Drug Administration have no U.S. manufacturing source. Most of the production occurs in India and China, according to the study.
Fiorello said the API Innovation Center wants to reverse those figures by engaging in programming and partnerships that drive innovation across policy, R&D and ingredient manufacturing. The nonprofit also hopes to partner on creating a R&D facility. Fiorello said that could include partnering with Washington University to develop a high-end collaborative lab space to test different methods of manufacturing inside of one of the former MERS Goodwill buildings near Cortex. The university owns the buildings.
Longer term, Fiorello is bullish that the efforts of the API Innovation Center will grow manufacturing innovation that leads to job growth in St. Louis.
“This is going after solutions that are going to lift up our region and provide opportunities,” he said.
The API Innovation Center is being funded through membership dues paid by the nonprofit’s member organizations. Fiorello said it will also target federal grants and other funding sources to back projects like the R&D facility and other research initiatives.
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