Applying supply chain insights and advanced manufacturing technologies to address critical drug shortages
The API Innovation Center (APIIC) and the U.S. Pharmacopeia (USP) have entered a strategic collaboration to investigate ways to solve real-world supply chain challenges impacting patients in the United States.
Many governmental and nongovernmental efforts aim to bolster medicine supply chain resilience and mitigate or prevent drug shortages. As part of the collaboration, APIIC and USP will support these efforts by expanding awareness among policymakers and administration officials on the state of critical drug shortages and the importance of strengthening domestic manufacturing capacity.
APIIC will coordinate the U.S. development, manufacturing, approval, and distribution of prioritized oncology drugs intended to achieve the greatest patient impact. USP will support the development and deployment of advanced manufacturing technologies, advanced analytical technologies, and methods to help strengthen local manufacturing capabilities for quality medicines.
“We are excited to work closely with USP, a leader in setting and upholding high standards of quality in the pharmaceutical industry,” said Anthony Sardella, Chair of APIIC. “Through this coordinated collaboration, we can accelerate the deployment of advanced manufacturing technology to help ensure the availability of critical medicines in the United States.”
“For patients, drug shortages can mean delayed treatments, missed treatments or the use of less effective treatments. The impact can be the difference between life and death,” said Dennis Hall, Vice President, Advanced Manufacturing Technologies, USP. “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.”
To learn more, read USP’s recent policy paper for key insights on adopting advanced manufacturing for medical products and Quality Matters article, “Drug Manufacturing Innovation: Building In Quality From the Start with USP.”
The API Innovation Center (APIIC) is a 501(c)(3) non-profit public benefit organization headquartered in St. Louis, Missouri, dedicated to delivering market-competitive commercial supply of US-made Active Pharmaceutical Ingredients (APIs) to address national health security. By fostering collaboration among a network of companies, academic and research institutions, and startups, APIIC stewards innovations in advanced manufacturing and enables solutions for drug supply chain fragility. The Center also works to create a diverse talent pipeline by partnering with local educational and apprenticeship programs that target underrepresented communities. APIIC is supported by the State of Missouri through the Advanced Manufacturing Resiliency Grant awarded by the Missouri Technology Corporation. To learn more about APIIC, visit: www.apicenter.org.
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality resources and standards for medicines, dietary supplements and food ingredients. This includes actively collaborating with academic research centers, industry, and regulators to help with the adoption and implementation of advanced manufacturing technologies. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. For more information, visit: www.usp.org.