Our Innovation Ecosystem
Strategic partnerships powering our success
From our roots in the groundbreaking Novartis–MIT Center for Continuous Manufacturing to active collaborations with IMA, FDA, USP, and industry partners, CONTINUUS has built a network that has turned academic discovery into a regulatory-ready, industrial-scale reality.
Our collaborations, past and present, demonstrate that transformative innovation, particularly in highly regulated industries such as the pharmaceutical sector, rarely occurs in isolation. We have been honored to work with many dedicated and brilliant colleagues and remain devoted to the mission of increasing accessibility to much-needed drug products through continuous manufacturing.
Driving Innovation Through Academic, Industrial & Regulatory Partnerships
CONTINUUS thrives at the intersection of academia, industry, and regulatory leadership. By collaborating with world-class research institutions, global equipment manufacturers, pharmaceutical companies, and forward-thinking health authorities, we transform laboratory breakthroughs into scalable, regulatory-ready solutions that are redefining how medicines are made.
In 2007, Novartis and the Massachusetts Institute of Technology (MIT) initiated a long-term research collaboration aimed at transforming the production of pharmaceuticals. Novartis committed $65 million to the Novartis-MIT Center for Continuous Manufacturing, and the multidisciplinary faculty members, students, postdoctoral fellows, and staff scientists at MIT contributed to the work. Additionally, Novartis allowed some of their molecules to be early test cases, ultimately generating data that demonstrated to the industry and regulators that continuous processing could meet, and often exceed, batch standards.
Salvatore Mascia led the team that built the world’s first fully integrated API-to-tablet pilot-scale manufacturing line. While the Center’s initial research phase concluded in 2012, Salvatore, Stephen Born, and Bayan Takizawa established CONTINUUS Pharmaceuticals by licensing key patents developed at the Center. To this day, CONTINUUS maintains close ties with MIT.
Because most legacy equipment vendors lacked truly continuous unit operations, CONTINUUS forged a strategic partnership with IMA Active, the pharmaceutical division of the Italian machinery group IMA. The two companies co-developed some proprietary hardware, notably the continuous hot-melt extrusion/injection-molding module, and IMA took an equity stake in CONTINUUS’s 2014 Series A round. The partnership provides CONTINUUS with access to global fabrication, while IMA gains a front-row seat to next-generation manufacturing.
The US Food and Drug Administration has provided critical guidance for companies using continuous manufacturing and created its Emerging Technology Team (ETT) to shepherd innovative CMC submissions. The agency has also played a crucial role in CONTINUUS’s journey.
In 2016, the FDA awarded CONTINUUS a $4.4 million contract to help establish a science-based approach to create regulatory guidelines for continuous drug manufacturing. Then, in 2021, CONTINUUS secured a $69 million BARDA/DoD contract as part of the US Federal government’s efforts to reshore the manufacturing of strategic active pharmaceutical ingredients (API) and finished dosage drug products.
CONTINUUS has a good relationship with USP and has in the past worked together to develop continuous manufacturing standards, guidelines, and validation processes with the ultimate goal of strengthening America’s pharmaceutical supply chain.
Discover CONTINUUS
Learn how CONTINUUS is transforming and strengthening the pharmaceutical supply chain.Our Technology
Explore how CONTINUUS is transforming the pharmaceutical industry.Integrated API & DP Development
Learn how our Integrated Continuous Manufacturing technology works.GMP Manufacturing
Our GMP model and regulatory support.Our Ecosystem
Discover our partnerships with leading pharmaceutical and regulatory organizations.
Join the CONTINUUS Revolution
Learn how Integrated Continuous Manufacturing will transform your supply chain by reducing the cost of goods, increasing product quality, enhancing sustainability, and accelerating your path to market.