The API Innovation Center (APIIC) Has Announced a Cooperation Agreement to Accelerate the Adoption of Low-Cost, Flexible Pharmaceutical Manufacturing Technologies to Support Critical Medicine Production in the United States.
The API Innovation Center (APIIC) is exploring business arrangements with Missouri-based pharmaceutical manufacturing companies Mallinckrodt Pharmaceuticals (SpecGx LLC), Apertus Pharmaceuticals, and Sentio BioSciences. The APIIC’s intent is to collaborate and potentially form business partnerships with each organization. With a shared interest in the domestic production of critical Active Pharmaceutical Ingredients (APIs), these organizations have committed to work with the APIIC toward this goal.
The APIIC is particularly proud that today’s announcement is highlighted by partners who are specifically focused on creating an innovative and advanced manufacturing hub in Missouri. These partners represent capabilities across the pharmaceutical supply chain, including but not limited to the commercialization, development and manufacturing of key starting materials, APIs and finished drug products.
“Our public-private model of bringing together a supercluster of innovators, researchers, and manufacturers to develop and commercialize new technologies and manufacturing processes will significantly advance domestic biomanufacturing,” said Kevin Webb, Chief Operating Officer of APIIC. “It could also be a successful model for the nation,” added Webb.
“Mallinckrodt’s Specialty Generics Business proudly operates the largest Active Pharmaceutical Ingredient plant in the country, and we’re the largest US-based provider of FDA-identified essential medicines,” said Andrew Gonce, VP of Commercial and Strategy for Mallinckrodt Pharmaceuticals. “This collaboration with APIIC should strengthen our nation’s domestic manufacturing capabilities, with the goal of greater domestic production of critical medicines.”
“Apertus is proud to be at the forefront in the effort to reshore critical APIs,” said Rick Ryan, CEO of Apertus Pharmaceuticals. “Through this coordinated partnership with the APIIC, we can continue to develop and work together to deliver timely and sustainable reshoring solutions.”
The APIIC facilitates an epicenter of innovation fueled by stakeholder partnerships and expert networks for drug supply chain coordination across the entire pharmaceutical manufacturing continuum: from prioritizing drugs for reshoring through innovation in R&D to FDA-approved finished drug product. This coordinated approach between public entities and private enterprises offers the greatest likelihood of increasing supply chain resilience and lessening our dependence on foreign manufacturers.
“Sentio is proud to team up with the APIIC with our continued focus on innovation, technology development, pharmaceutical cGMP manufacturing, FDA registrations and commercialization of complex therapeutics. We are proud to be part of this community of innovators working towards critical medicine production in the United States,” said Karthik Raghaven, President and CEO of Sentio BioScience. “Ensuring access to these medications is vital to our public health security.”
The APIIC was recently awarded a $9.45 million grant from the Missouri Technology Corporation (MTC) and the state of Missouri to establish an API innovation manufacturing hub for the development and production of critical drugs of strategic national importance. In addition, the APIIC was awarded $500,000 from the U.S. Economic Development Administration Build Back Better Regional Challenge grant for advanced manufacturing equipment to expand domestic API manufacturing.
The API Innovation Center is a 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, the 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. To learn more about APIIC, visit: www.apicenter.org.
About Apertus Pharmaceuticals:
Apertus was founded in 2012 by Dr. Gindelberger and Dr. Ryan. Initially, the team focused on API development but quickly added formulation projects. After opening their doors, they obtained a DEA manufacturing registration quickly followed by research and analytical registrations. Their first customers were other small companies in the St. Louis area with lab support needs. They developed analytical and manufacturing procedures for a diverse array of products from magnetic nano-particles to extended-release drug products. They then expanded their capabilities to include small-scale cGMP manufacture of drug products. To learn more about Apertus Pharmaceuticals, visit: www.apertuspharma.com
About Mallinckrodt Pharmaceuticals:
Mallinckrodt Pharmaceuticals is a multibillion-dollar specialty pharmaceutical company focused on its mission: Listening for Needs. Delivering Solutions. The Company provides medicines to address unmet patient needs, stemming from over 155 years of using its unique strengths, experience and expertise to help improve people’s lives. To learn more about Mallinckrodt Pharmaceuticals, visit: www.mallinckrodt.com
About Sentio BioSciences:
Sentio BioSciences LLC was founded in 2008 with 2 FDA-approved drug products on the U.S. market. Sentio is an innovative pharmaceutical company focused on Animal and Human Health, Research & Development, cGMP Manufacturing and Regulatory Compliance and Submissions. Sentio’s manufacturing suites are vertically integrated to minimize the reliance on material from overseas markets. It currently manufactures FDA-approved pharmaceutical APIs, drug products, and intermediate products. Sentio manufactures medical devices for clinical studies. Sentio, as a Small Business, has FDA-audited strong quality systems in place and are now focused on rapidly developing and scaling up new products through the regulatory process to commercialization. To learn more about Sentio Biosciences, visit: www.sentiobiosciences.com