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Under this agreement, Acuitas Therapeutics’ LNP technology platform will be transferred to BIOVECTRA for use in manufacturing mRNA-based therapies.
BIOVECTRA and Acuitas Therapeutics have entered into a technology transfer service agreement, through which Acuitas’ lipid nanoparticle (LNP) technology platform for manufacturing messenger RNA (mRNA)-based therapeutics will be transferred to BIOVECTRA’s new biomanufacturing center currently being built at its Charlottetown, Prince Edward Island site in Canada.
Under the agreement, BIOVECTRA will formulate Acuitas’ LNP for licensed therapeutic partners for clinical and commercial products using a variety of payloads. Acuitas’ LNP technology is currently used in multiple vaccines and therapeutics in clinical development. The technology is also used in the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY, according to an Oct. 5, 2023 company press release.
The tech transfer will occur in BIOVECTRA’s biomanufacturing center in Charlottetown, which is expected to be completed in late 2023. Upon completion, the facility will support the good manufacturing practice manufacturing of plasmid DNA, mRNA, and LNP formulations. The 36,000 additional ft2 will be able to produce the equivalent of 160 million doses of mRNA vaccines and will have the capability to fill/finish 70 million final vaccine doses per year for commercial distribution, according to the press release.
“We are thrilled about this partnership with Acuitas Therapeutics … ,” said Marc Sauer, chief science officer, BIOVECTRA, in the press release. “Our work together will provide their licensed partners with faster market access to CGMP [current good manufacturing practice]-quality LNPs for early and late-stage products. BIOVECTRA looks forward to continuing to make a difference in patients’ lives by supporting GMP and commercial-ready LNP formulation at our new mRNA biomanufacturing facility in Atlantic Canada.”
“LNP-based mRNA medicines provide the opportunity to address an incredibly wide range of health conditions, from infectious diseases such as COVID-19, flu, and malaria to therapeutic areas related to heart disease, or cancer, as well as many rare diseases,” said Chris Barbosa, vice-president, Technology Development, Acuitas Therapeutics, in the release. “As we move forward in the development process in all of these areas with our partners, the demand for Acuitas’ clinical-grade LNP for our partners increases exponentially. We look forward to working with the BIOVECTRA team to expand the CGMP manufacturing capacity for Acuitas’ LNP so that we can continue to meet the growing needs of our global partners.”