The Coalition for Epidemic Preparedness Innovations (CEPI) and CDMO Samsung Biologics formed a partnership to strengthen vaccine manufacturing preparedness for future epidemic and pandemic threats. The collaboration will see Samsung Biologics join CEPI’s Vaccine Manufacturing Facility Network (VMFN) with the aim of accelerating the availability of protein-based vaccines and advancing equitable access to those vaccines during future outbreaks in Low- and Middle-Income Countries (LMICs).
Supported by an initial budget of up to $20 million, CEPI will work with Samsung to establish a scalable, rapid manufacturing process for recombinant-protein vaccines.
Under the agreement, Samsung Biologics will also conduct a simulated outbreak response exercise using a wild-type H5 influenza as a prototype pathogen recommended by the WHO. The exercise is designed to demonstrate the speed and robustness of the company’s end-to-end capabilities, from antigen development through to vaccine drug product manufacture to supply, explained a Samsung spokesperson, who noted that this simulation will provide insights into how quickly recombinant-protein vaccines can be manufactured at scale in an outbreak scenario and help lay the grounds to prepare a generic regulatory submission dossier.
By joining CEPI’s global VMFN, in a future pandemic situation, Samsung will provide CEPI with guaranteed access to up to potentially 50 million vaccine doses, and an additional one billion doses of drug substance ready to be converted into finished vaccines. This arrangement reserves doses for vulnerable populations in underserved LMIC regions and at the same time, enables Korea’s national needs to be met in line with CEPI’s Equitable Access Policy, according to Richard Hatchett, MD, CEO of CEPI.
“Partnering with one of the world’s foremost recombinant protein contract manufacturers will help us move more rapidly from prototype sequence to production and get vaccines to the underserved global communities that need them most,” he said.
The partnership supports CEPI’s 100 Days Mission, a global effort to develop vaccines within 100 days of identifying a novel pathogen with pandemic potential, by putting in place pre-agreed, end-to-end manufacturing pathways that enable rapid scaling.
“By working with CEPI to advance recombinant protein vaccine development and ensure capacity for timely production when demand rises, we aim to broaden access to high-quality vaccines for patients around the world,” added John Rim, president and CEO of Samsung Biologics.
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