Continuus to Build GMP End-to-End Continuous Manufacturing Facility

A contract from the US government will help fund domestic US production of small-molecule APIs and finished dosage forms and will be the first GMP facility using ICM technology.

Continuus Pharmaceuticals received a US government contract to build a continuous manufacturing facility for US-production of critical APIs and finished dosage forms, the company announced in a Jan. 21, 2021 press release. The $69.3 million contract will help the company to commercialize its Integrated Continuous Manufacturing (ICM) technology for end-to-end production of small-molecule drugs.

The contract was awarded by the Department of Defense (DoD) in conjunction with the US Department of Health and Human Services (HHS) and was funded through the Coronavirus Aid, Relief, and Economic Securities (CARES) Act, the DoD said in a Jan. 15, 2021 announcement. 

Continuus plans to break ground for the new facility in Woburn, MA in late January 2021 and intends to make the plant fully operational within two years. The facility will be the first US good manufacturing practices (GMP)-certified facility for end-to-end, ICM-based production of small-molecule drugs. The company says it will produce vital medicines, including for treating COVID-19, and that production will include marketed products, generic medications, and investigational therapies through all phases of clinical trials and a product's lifecycle.

"We are honored to receive this important contract from the Departments of Defense and Health and Human Services, both of which recognize the urgency of ramping up domestic production of critical-care medicines," said Salvatore Mascia, founder and CEO of Continuus Pharmaceuticals, in the press release. "In addition to streamlining continuous, environmentally friendly, and cost-efficient production of these medicines, this contract will help us build a state-of-the-art facility that will address urgent pharmaceutical supply chain issues, ultimately speeding the delivery of high-quality, affordable medications to patients, while also creating US-based jobs."

The ICM technology reduces drug production time from months or years to just a few days, which will help to mitigate hospital and pharmacy shortages of critical drugs. The approach also enables manufacturing of multiple drugs in quick succession with lines that can be easily transported between locations.

"Beyond addressing national security needs in obtaining critical-care medicines from overseas, we will work with hospitals and pharmacies to ensure that other key drugs, such as epinephrine and ciprofloxacin, are never again in shortage," said Bayan Takizawa, MD, co-founder and chief business officer of Continuus, in the press release. "The impact on the pharmaceutical industry will also be significant, as our technology eliminates the typical delays associated with scale-up, allowing companies to accelerate development of small-molecule drugs for faster delivery to patients in need."

Sources: Continuus , US DoD