Samsung Biologics will develop a “ready-to-activate” vaccine manufacturing process that can be deployed during health emergencies, under a new agreement with the Coalition for Epidemic Preparedness Innovations (CEPI). The agreement will see Samsung join CEPI’s Vaccine Manufacturing Facility Network (VMFN), which is a group of firms focused on ensuring that protein-based vaccines are available during outbreaks.
Matthew Downham, CEPI’s director of manufacturing and supply chain networks, tells GEN, “Through this partnership, CEPI and Samsung Biologics will establish a pre-agreed, ready-to-activate manufacturing process for recombinant protein vaccines that can be deployed rapidly in a future epidemic or pandemic.
“The focus is on mammalian cell–based production, a well-established and highly scalable approach used globally for protein-based biologics,” he continues. “The objective is not to develop a single vaccine in advance, but to ensure that manufacturing pathways are in place so production can begin quickly once a new pathogen is identified.”
Under the deal—which has an initial budget of $20 million—Samsung will develop a rapid production process for recombinant-protein vaccines based on its established mammalian cell-based manufacturing infrastructure.
The CDMO has agreed to make 50 million doses of vaccine in the event of a pandemic, some of which will be reserved for vulnerable populations in underserved LMIC regions. It has also committed to providing CEPI with one billion doses of drug substance ready to convert into vaccines.
In addition, Samsung will carry out a simulated outbreak using an influenza virus to test how quickly it can produce a vaccine and prepare a submission dossier that can be filed with regulators should the need arise.
Tech transfer and regulatory preparedness
The agreement also includes provisions that will see Samsung support technology transfer and regulatory preparedness.
“The partnership is explicitly designed to minimize activation time. By pre-agreeing manufacturing processes, running outbreak simulations, and preparing regulatory groundwork in advance, CEPI and Samsung Biologics aim to move from pathogen sequence to large-scale production far faster than traditional timelines,” says Downhan.
“While exact timelines depend on the pathogen and vaccine design, this work directly supports CEPI’s 100 Days Mission, which seeks to make vaccines ready for deployment within 100 days of identifying a novel pandemic threat.”
Samsung is the first East Asian manufacturer to join CEPI’s network, which includes Fiocruz in Brazil, the Serum Institute in India, Bio Farma in Indonesia, Aspen in South Africa, and Institut Pasteur de Dakar in Senegal.
“Together, these partners form a globally distributed manufacturing ecosystem spanning Latin America, Southeast Asia, Western Pacific, and Africa, intended to reduce geographic concentration of vaccine manufacturing and supply to improve speed, scale, and equity of vaccine access during future outbreaks in LMIC regions,” explains Downham.
At present, Samsung has a combined biomanufacturing capacity of 785,000 L across two sites—called Bio Campus I and II—in Incheon, South Korea.
In December, the CDMO said it would add 60,000 L of bioreactor capacity through the acquisition of GSK’s facility in Rockville, MD, in a deal due to complete at the end of Q1.
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