美通社

2024-10-09 23:37

Centivax Selects Global CDMO BioCina to Initiate cGMP Manufacturing of Revolutionary Universal Influenza Vaccine

ADELAIDE, South Australia, Oct. 9, 2024 /PRNewswire/ -- BioCina Pty Ltd., a global end-to-end biologics Contract Development and Manufacturing Organization (CDMO), announced a new partnership with Centivax, Inc., for a project involving cell line development, cell banking and plasmid DNA manufacture. Centivax is developing Cent-Flu, a universal influenza vaccine, consisting of a proprietary multivalent mixture of 22 unique mRNA transcripts delivered as a lipid nanoparticle (LNP) encapsulated mRNA vaccine. In vivo, the vaccine has been demonstrated to convey protection against current, past, and future influenza strains. BioCina will provide proven expertise in the selection of optimal plasmid manufacturing cell lines, Master Cell Bank (MCB) and plasmid manufacturing, to support Centivax's progression to First-in-Human clinical trials.

Centivax Selects Global CDMO BioCina to Initiate cGMP Manufacturing of Revolutionary Universal Influenza Vaccine.
Centivax Selects Global CDMO BioCina to Initiate cGMP Manufacturing of Revolutionary Universal Influenza Vaccine.

 BioCina's Chief Executive Officer, Mark W. Womack stated, "We're privileged to support Centivax's breakthrough approach to sustained flu prevention and we couldn't be more excited to be their partner of choice to initiate cGMP manufacturing, thus advancing the journey to bring such an important vaccine to market. This is a tremendous opportunity for the BioCina Team to leverage our world-class capabilities in cell line development, cell banking, and cGMP plasmid production."

Centivax's Chief Executive Officer, Jacob Glanville, said, "We are thrilled to announce BioCina as our Master Cell Bank manufacturing partner for the first phase of manufacturing our universal influenza vaccine. BioCina's exemplary expertise and track record in mRNA/LNP MCB, combined with their state-of-the-art facilities, aligns perfectly with Centivax's commitment to innovation and quality. This partnership enables us to leverage BioCina's expertise to ensure the highest standards of vaccine production. Together, we're taking a significant step forward in bringing our universal influenza vaccine to market, with the goal of providing broad, lasting protection against the disease on a global scale."

About BioCina
BioCina is a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO), offering highest-quality, cost-effective cell line, process, analytical and formulation development, and cGMP clinical & commercial manufacturing for the microbial, pDNA and mRNA modalities. BioCina's first facility in Adelaide, South Australia has a rich history of developing and manufacturing both clinical and commercial drug substance, backed by most critical SME's having an average tenure of 15+ years at the site. BioCina boasts an elite quality record having successfully passed regulatory inspections by the US FDA, EMA, TGA and Health Canada. Through a partnership with NovaCina, BioCina offers clients a highest-quality fill-and-finish solution. BioCina is proud to have clients globally, including the U.S., Europe, and the Asia Pacific. Australia offers one of the most attractive tax incentives globally (up to 48.5% cash refund), and one of the world's premier trial networks, making it an ideal destination for biologics companies looking to invest in scaling-up and manufacturing products. Visit https://biocina.com.

About Centivax
Centivax is a universal vaccine platform technology company founded and led by experts in vaccinology, vaccine regulatory affairs, immunology, and computational bioengineering. The universal vaccine platform intellectual property has demonstrated unprecedented breadth of protection against influenza and coronaviruses. The platform delivers ultra-broad neutralizing titers, HAI titers and in-vivo protection in ferrets, pigs, rats, mice and human immune organoids. Development of the Centivax platform has been financially supported by the Global Health Investment Corporation (GHIC) BARDA venture arm, NFX, BLUE KNIGHT™ J&J/BARDA program, the Bill and Melinda Gates Foundation, the National Institute of Health (NIH), the Naval Medical Research Center, the Walter Reed Army Institute of Research, the Medical Technology Enterprise Consortium, the Department of Defense, and the National Institute for Innovation in Manufacturing Biopharmaceuticals. Centivax is on a mission to accelerate the world's transition to a post-pathogen humanity.

Media Contact
media@biocina.com 

source: BioCina

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