Biovectra, Acuitas Ink Tech Transfer Agreement for LNP Delivery System

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.”

PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

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