Pharma Focus Europe

BIOVECTRA and Acuitas Therapeutics Enter Into Partnership for Unique Lipid Nanoparticle (LNP) Delivery System in the Production of MRNA-based Therapies

Friday, October 06, 2023

BIOVECTRA and Acuitas Therapeutics, Inc. have announced a collaborative technology transfer service agreement. BIOVECTRA will gain access to Acuitas' advanced Lipid Nanoparticle (LNP) technology platform for manufacturing mRNA-based therapeutics on a non-exclusive basis.

Marc Sauer, Ph.D., Chief Science Officer of BIOVECTRA, expressed excitement about the partnership with Acuitas Therapeutics, a leader in LNP delivery systems. He emphasized that this collaboration would accelerate the availability of cGMP-quality LNPs for early and late-stage products to Acuitas' licensed partners. He also highlighted BIOVECTRA's commitment to impacting patients' lives positively by supporting GMP and commercial-ready LNP formulation at their new mRNA biomanufacturing facility in Atlantic Canada.

Within this partnership, BIOVECTRA will be responsible for formulating Acuitas' LNPs for licensed therapeutic partners, catering to both clinical and commercial product needs across various payloads. Acuitas' proprietary LNP technology has played a significant role in multiple vaccines and therapeutic developments, including the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY®, which received regulatory approval and has been administered globally.

Dr. Chris Barbosa, Vice President of Technology Development at Acuitas Therapeutics, emphasized the broad potential of LNP-based mRNA medicines, spanning from infectious diseases like COVID-19, flu, and malaria to therapeutic areas such as heart disease, cancer, and rare diseases. As the demand for Acuitas' clinical-grade LNPs continues to rise with ongoing developments, the partnership with BIOVECTRA will enable an expansion of cGMP manufacturing capacity, ensuring the ability to meet the increasing needs of global partners.

This collaborative effort will take place at BIOVECTRA's biomanufacturing center, set for completion later in the year. This facility will support the GMP manufacturing of plasmid DNA, mRNA, and LNP formulations. It will expand BIOVECTRA's Charlottetown campus by 36,000 square feet and have the capability to produce an equivalent of 160 million doses of mRNA vaccines while also providing fill/finish services for 70 million final vaccine doses annually for commercial distribution. This facility effectively offers an end-to-end manufacturing solution for BIOVECTRA's clients. BIOVECTRA is already well-prepared with an expert team at the bench scale for the technical transfer of nucleic acid processes intended for production in these new facilities. Additionally, the company has a track record of GMP commercial supply, encompassing lipids, complex API's, and drug substances, from its five GMP facilities in Eastern Canada.

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