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.”
Check out our AAV CDMO service to expedite your gene therapy research
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
Sangamo Therapeutics Secures Accelerated Approval Pathway for Gene Therapy in Fabry Disease
Sangamo Therapeutics has announced a major advancement in its gene therapy program for Fabry disease, as the U.S. FDA has provided a clear pathway for Accelerated Approval. This decision could potentially speed up approval timelines by three years, with a Biologics...
[2024/10/18] Gene and Cell Therapy- weekly digest from PackGene
FeaturedNewsArticlesPackGene's NewsletterReceive the latest news and insights to your inbox.About PackGenePackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span...
GSK sues Moderna over mRNA vaccine patents, seeks ‘reasonable royalty’
GSK on Tuesday unveiled a lawsuit filed against Moderna in Delaware federal court, alleging that its patented inventions provide the “foundation” for Moderna’s mRNA vaccine portfolio. GSK said it’s looking to recover “a reasonable royalty” for Moderna’s tens of...
Gene Therapy Automatically Converts Omega-6 to Omega-3 Fatty Acids in the Body
Shriners Children's Develops New Technology to Prevent Childhood Obesity ST. LOUIS, Oct. 16, 2024 /PRNewswire/ -- According to the Centers for Disease Control, nearly 20% of children and teens are considered obese. Research shows it can have a dramatic impact on a...
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
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