Partnership offers a commercial GMP manufacturing solution for Acuitas’ licensed partners developing next generation therapies.

Biovectra and Acuitas Therapeutics, Inc. have entered into a technology transfer service agreement under which Biovectra will accept, on a non-exclusive basis, Acuitas’ best-in-class LNP technology platform for manufacturing mRNA-based therapeutics.

Through this partnership, Biovectra will formulate Acuitas’ LNP for licensed therapeutic partners for clinical and commercial products using a variety of payloads. Acuitas’ LNP technology is used in multiple vaccines and therapeutics.

The work will occur in Biovectra’s new biomanufacturing center, which, upon completion later this year, will support the GMP manufacturing of plasmid DNA, mRNA and LNP formulations. This facility adds 36,000 square feet to Biovectra’s existing Charlottetown campus and will be able to produce the equivalent of 160 million doses of mRNA vaccines and to fill/finish 70 million final vaccine doses per year for commercial distribution.

Currently, Biovectra is fully equipped and staffed with a team of experts at bench scale, to begin the technical transfer of nucleic acid processes that will be destined for manufacture in these new facilities. It also provides GMP commercial supply of lipids (including custom ionizable lipids), complex API’s and drug substances, from its five GMP facilities in Eastern Canada.

“We are thrilled about this partnership with Acuitas Therapeutics, a global leader in LNP delivery systems,” said Marc Sauer, chief science officer, Biovectra. “Our work together will provide their licensed partners with faster market access to cGMP-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. Barbosa added: “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.”

Source: https://www.contractpharma.com/contents/view_breaking-news/2023-10-05/biovectra-acuitas-ink-tech-transfer-agreement-for-lnp-delivery-system/9769
GMP mRNA
Check out our AAV CDMO service to expedite your gene therapy research
About PackGene

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Scientists develop potential stealth cancer therapy

Credit: ACS Central Science (2024). DOI: 10.1021/acscentsci.4c00559Sneaking by cancer's defenses, by disguising tumor-fighting antibodies inside the molecules cancer uses to nourish tumor growth, is the basis of a novel therapy from Yale Cancer Center researchers at...

read more

Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.

READ MORE

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.

READ MORE

aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.

READ MORE