The API Innovation Center, (APIIC), the St. Louis-based nonprofit focused on strengthening the U.S. supply chain for pharmaceutical ingredients, has formed a pact with a pharmaceutical standards group.
APIIC and Rockville, Maryland-based U.S. Pharmacopeia (USP) have launched a strategic collaboration the two organizations say will “investigate ways to solve real-world supply chain challenges,” with a focus on examining how advanced manufacturing can help boost U.S. production of pharmaceutical ingredients used in cancer drugs.
Launched in 2021 as the Active Pharmaceutical Ingredients Innovation Center, APIIC is a nonprofit organization that seeks to bring together businesses, researchers, academics and experts to find ways in which the U.S. can increase production of pharmaceutical ingredients. It launched through the Cortex Innovation Community. USP is an independent scientific group that works with academics, businesses and regulators to set standards for development of medicines, dietary supplements and food ingredients.
APIIC and USP said they plan to work together as the St. Louis nonprofit seeks to “coordinate the U.S. development, manufacturing, approval and distribution of prioritized oncology drugs.” USP will assist in efforts to use advanced manufacturing and other technologies to bolster development of those drugs, it said.
“No single government agency or any individual industry organization can solve supply chain vulnerabilities or drug shortages. We are pleased that we can bring to bear USP’s analytics and insights to further our collective understanding of supply chain vulnerabilities and help with the implementation of advanced technologies such as continuous flow and new analytical quality solutions,” said Dennis Hall, USP's vice president of advanced manufacturing technologies.
APIIC Chief Operating Officer Kevin Webb said a partnership with a standards group like USP is “critically important to making sure we have eyes on what the U.S. Food and Drug Administration needs” as efforts are made to boost drug manufacturing domestically. Webb said advanced manufacturing will speed up manufacturing and reduce costs, two critical components to reshoring production of drugs.
“That’s the value,” Webb said.
APIIC and USP said their partnership will also include discussions with policymakers to educate them about drug storage and initiatives to manufacture therapeutics domestically. Webb said it's an issue he believes can draw bipartisan support because of its implications on national security, workforce development and public health.
“That’s something everybody can like,” he said.
APIIC’s first project since its launch has been an initiative to create a source of U.S.-produced API for lomustine, a chemotherapy drug used to treat glioblastoma, an aggressive form of brain cancer. APIIC reported total revenue of $107,679 and total expenses of $188,148 for the year ended Dec. 31, 2022, according to its most recent IRS filing. APIIC in 2023 received a $9.5 million grant from Missouri Technology Corp., the private-public organization that supports innovation and entrepreneurship in Missouri. The nonprofit has a staff of eight.
