St. Louis-based API Innovation Center achieves groundbreaking milestone in creating reliable, efficient source for active ingredients used in lomustine for the treatment of brain cancer

The drug API Innovation Center today announced it has reached a milestone in the development of technology essential to accelerating the U.S. production of lomustine, a critical cancer medication, and will collaborate with St. Louis-based Apertus Pharmaceuticals to expand its manufacturing in Missouri. 

In the fight against glioblastoma – the most common and aggressive form of malignant brain cancer – doctors and patients turn to lomustine, a leading chemotherapy treatment relying on active pharmaceutical ingredients (APIs) produced off U.S. shores. 

Through the adoption of new, continuous manufacturing technologies, the API Innovation Center’s partnership with the Glioblastoma Foundation and Apertus aims to deliver high-quality U.S.-made lomustine, helping reduce patient costs and ensure availability of supply for cancer patients.

“When faced with glioblastoma, no one should have to be worried about the cancer drug they need being in shortage or being cost-prohibitive,” said Gita Kwatra, chief executive officer, Glioblastoma Foundation. “Partnership is key to resolving the lomustine crisis in the U.S. and working with the API Innovation Center and Apertus Pharmaceuticals, we now have the ability to provide patients with a safe, affordable U.S.-produced source of generic lomustine.” 

Manufacturing Innovation Vital for High-quality, U.S.-made Lomustine

Apertus will adopt the continuous flow advanced biomanufacturing solutions funded by the API Innovation Center and developed by the organization’s key research members.

“Apertus Pharmaceuticals is proud to be selected as the contract manufacturer for lomustine,” said David Gindelberger,president and chief scientific officer of Apertus Pharmaceuticals. “We are committed to working with the API Innovation Center and the Glioblastoma Foundation to ensure certainty of supply of lomustine for glioblastoma patients and glioblastoma clinical trials.”

As part of this collaboration, Apertus and the API Innovation Center will also invest in the establishment of an oncology production suite in Missouri, expanding the state’s biomanufacturing base and Apertus’s ability to manufacture additional drugs for retail, hospital systems, and the cancer patients they serve.

“The results of our lomustine project make it clear: A more efficient, cost-effective and sustainable route to pharmaceutical production is possible on U.S. soil,” said Tony Sardella, chair and founder of the API Innovation Center. “Working with our research and manufacturing partners, we are committed to strengthening the availability of high-quality, generic medications for cancer patients, healthcare systems, and retail pharmacies through the research and collaboration required to revolutionize the way our most relied-upon medications are made.” 

Collaborating to Expand Manufacturing in Missouri 

This announcement backs Missouri’s dedication to innovation in bioscience, healthcare, and advanced manufacturing for job growth and economic development and the security of the national pharmaceutical supply chain.

“The API Innovation Center’s latest accomplishments with lomustine is a testament to Missouri’s leadership in finding solutions that address our nation’s dependency on foreign production of critical pharmaceuticals,” said Sen. Lincoln Hough, R-Springfield. “I’m proud of the role the API Innovation Center, and Missouri, is playing to answer a vital national security concern.”

The API Innovation Center collaborates with state leaders to enhance national health security and position Missouri as a hub for essential pharmaceutical manufacturing. 

“The St. Louis region is at the forefront of emerging technologies and API production,” said Sen. Brian Williams, D- St. Louis. “The state’s investment in the API Innovation Center and its advancements through the lomustine project show the power of public-private partnerships in promoting the greater good and economic development opportunities for the state.”

In 2023, the API Innovation Center was awarded $9.5 million from the Missouri Technology Corporation’s Advanced Manufacturing Resiliency Grant Program. With this support, the API Innovation Center is investing in building a regional hub for drug advanced manufacturing, establishing Missouri as a leader in domestic API production to secure the U.S. essential drug supply chain.

“The Missouri Technology Corporation is proud to further the work of the API Innovation Center and help foster the growth of Missouri’s manufacturing base,” said Dan Cobb, Chairman of the Missouri Technology Corporation. “Providing investments for industries that are fundamental to the national security of the U.S. will help keep production of essential goods in Missouri and help create an environment for significant economic growth.”

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About the API Innovation Center:

The API Innovation Center (APIIC) is a 501(c)(3) nonprofit public benefit organization headquartered in St. Louis, Missouri, dedicated to revolutionizing pharmaceutical development through cutting-edge research in chemical and semi-synthetic research. By developing and leveraging advanced manufacturing technologies, APIIC aims to create sustainable and efficient routes for producing vital pharmaceuticals in the U.S. Through investments in and collaboration along the supply chain, APIIC’s model contracts leading U.S.-based specialists within their pharmaceutical ecosystem to develop and manufacture Active Pharmaceutical Ingredients (APIs), ensuring high-quality domestically produced pharmaceuticals. APIIC is committed to expanding access to critical medications through strategic partnerships to commercialize market-competitive supplies of finished drug products. Their mission is to ensure every hospital, pharmacy, and American has access to domestically produced critical medication to support national health security. APIIC is supported by the state of Missouri through the Advanced Manufacturing Resiliency Grant awarded by the Missouri Technology Corporation. To learn more, visit: apicenter.org.

About Apertus Pharmaceuticals:

Apertus Pharmaceuticals is a Contract Development and Manufacturing Organization (CDMO) that develops and manufactures device, OTC and prescription pharmaceutical products.  Services include product de-formulation, formulation development, process development and manufacturing (clinical batch to intermediate scale), including product serialization. Apertus performs an extensive range of analytical method development and validation as well as stability programs for all of the dosage forms it produces. Apertus currently manufactures solid oral dose, suppository, liquid and cream products.  Apertus is cGMP compliant and maintains  DEA research and analytical registrations for Schedules II-V. To learn more about Apertus Pharmaceuticals, visit: apertuspharma.com.

About Glioblastoma Foundation:

Glioblastoma Foundation, Inc. is a national 501(c)(3) nonprofit charitable foundation headquartered in Durham, North Carolina. The mission of the Glioblastoma Foundation is to transform the standard of care for glioblastoma by supporting the development of new drugs and other effective therapies. The Glioblastoma Foundation uses funds to support research that will transform glioblastoma into a treatable condition. Contactinfo@glioblastomafoundation.org for more information, or visit glioblastomafoundation.org.

About the Missouri Technology Corporation:

The Missouri Technology Corporation (MTC) is a public-private partnership created to foster innovation and entrepreneurship within the state of Missouri. By providing strategic investments and support to Missouri-based high-tech companies, MTC aims to drive economic growth and create a thriving ecosystem for technology-based businesses. For more information, visit missouritechnology.com