In October 2023, BioVectra, a global biotech and contract development and manufacturing organization (CDMO) based in Charlottetown, Prince Edward Island, Canada, signed a service agreement with Acuitas Therapeutics for a unique lipid nanoparticle (LNP) delivery system used in manufacturing mRNA-based therapies. Under the agreement, Acuitas’ licensed users can contract with BioVectra for an accelerated path to GMP production.

Vancouver-based Acuitas is a private biotech specializing in the development of delivery systems for nucleic acid therapeutics based on LNPs.

BioVectra specializes in clinical-to-commercial scale production capabilities for biologics, small molecules, bioreagents, lipids, pDNA, mRNA and LNP manufacturing from facilities in Prince Edward Island and Nova Scotia.

Contract Pharma recently interviewed BioVectra’s chief science officer, Marc Sauer, PhD, about the partnership with Acuitas and the expansion of BioVectra’s Charlottetown facility, where the work will occur.

Contract Pharma: Can you provide an overview of the partnership between BioVectra and Acuitas?

Marc Sauer: BioVectra and Acuitas have 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.

CP: What prompted the collaboration between the two companies?

Sauer: Acuitas and BioVectra are both Canadian companies that offer world class services in their field. Our work together will provide Acuitas’ licensed partners with faster market access to cGMP-quality LNPs for early and late-stage products. BioVectra is ready to perform technology transfers and 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.

CP: How does each company’s expertise complement the other in the context of biomanufacturing?

Sauer: Acuitas’ proprietary LNP technology is used in multiple vaccines and therapeutics in clinical development and enables COMIRNATY, the Pfizer-BioNTech COVID-19 vaccine that was first to receive regulatory approval and that has been administered to people in 180 countries. Acuitas continues to license their technology to clients around the globe and BioVectra offers development and manufacturing capabilities that allow Acuitas partners a platform to advance their projects to the clinical stage and beyond.

CP: How does this collaboration align with BioVectra’s long-term goals?

Sauer: Collaborating with partners such as Acuitas offers access to experts in creating innovative lipids and novel mRNA-lipid nanoparticle formulations. These efforts are geared towards enhancing stability and optimizing packaging methods for mRNA.

Acuitas Therapeutics is a global leader in LNP delivery systems. Our work together will not only strengthen the solid and valuable biomanufacturing foundation in Canada but will enable Acuitas’ licensed users globally to access solutions for GMP grade production of LNPs for important and emerging therapies. BioVectra will enable Acuitas’ licensed customers domestically and globally to accelerate their path to clinical and commercial applications. It is also important to note that this agreement is non-exclusive. BioVectra also offers process development, scale up, and technology transfer of any LNP system. Additionally, we are experienced in manufacturing custom lipids as well.

CP: What are some of the key features and capabilities of BioVectra’s new biomanufacturing facility in Charlottetown?

Sauer: With the addition of our new biomanufacturing center, we can offer our clients end-to-end services from non-GMP pre-clinical development to commercial manufacturing under cGMP for drug substance and drug product.

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, providing an end-to-end manufacturing solution for BioVectra’s clients.

In addition, the expansion of our biologics capabilities into pDNA and mRNA vaccines/therapeutics and lipid nanoparticle opens a world of new possibilities to our clients. The potential to impact many patients’ lives and to be part of the solution to treat previously incurable diseases and illness is extraordinary.

CP: What specific technologies or innovations are integrated into the facility?

Sauer: We offer complete solutions from cell banking, plasmid development and manufacturing, mRNA drug substances, LNP formulation and sterile fill-finish. We embedded single-use technology throughout the entire process train and are taking advantage of continuous operations, e.g. cell lysis, wherever possible.

The facility features two Cytiva SA25 Robotic Filling Machines. This cutting-edge technology is a highlight for the new facility. Up to 20,000 2 ml vials can be filled in a 24-hour period and between 10,000 to 12,000 vials in the 10 ml format.

CP: How do these advancements contribute to efficiency, quality, or sustainability in the biomanufacturing process?

Sauer: Unlike typical aseptic isolator filling machines, which need glove ports to allow operators to perform interventions during the filling process, the SA25 is a completely robotic system that eliminates human interactions with the product increasing overall sterility assurance of the process.

CP: Are there any unique aspects of the facility that set it apart in the industry?

Sauer: The new biomanufacturing facility was built-for-purpose and is not a retrofit of an existing footprint. This allowed us to optimize work and material flow specific to an end-to-end solution for mRNA-based therapeutics and vaccines.

CP: How does the partnership and new facility impact BioVectra’s position in the market?

Sauer: Advanced modalities are expected to be a high growth sector in the biomanufacturing sector for years to come and with this new facility BioVectra has positioned itself as a leading CDMO in this space.

In terms of the Acuitas partnership, 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.

CP: Are there potential implications for the broader biopharmaceutical industry?

Sauer: This suite of BioVectra capabilities specialized in mRNA, pDNA, lipid nanoparticle and fill/finish work is unique and the first of its kind in Canada. It marks a milestone in Canada’s strategy for better preparedness in a future health crisis by creating specialized domestic biomanufacturing capacity.

CP: What can the industry expect from BioVectra moving forward?

Sauer: BioVectra has a rich 50-year history in the business, and our strategic move into the mRNA space was a logical step, closely aligned with our existing core competencies. Unlike companies that are venturing into this area from scratch, we are not new to the game. We have the right people, the right team, and a well-established support structure in place to guide our clients effectively.

Our quality systems have been routinely inspected and approved by regulatory authorities like the U.S. FDA, Health Canada, and the PMDA in Japan. We also collaborate with most of the world’s top pharmaceutical companies, with 18 out of the top 20 having inspected our quality systems. This extensive experience positions us well to assist our clients in navigating the intricate regulatory landscape.
Our approach extends to academic and industry collaborations, reinforcing our commitment to continuous learning and growth. The Canadian ecosystem offers a fertile ground for such partnerships.

Academic collaboration not only enrich our understanding of the science but also broaden our problem-solving capabilities. This is crucial, given that the cost of mRNA therapeutics is currently prohibitive for many new therapeutics. We are actively exploring alternative approaches to processes, such as In Vitro Transcription (IVT) reactions, with the aim of delivering high-quality products at a reasonable price.

Change is indeed challenging, but it is necessary for progress. While change may not always lead to the perfect process, it allows us to learn and adapt. An example is the initial skepticism surrounding single-use reactors. Many initially questioned the idea of conducting reactions in plastic bags, but eventually, it became an accepted and efficient practice. I’m grateful that at BioVectra we’re always looking to innovate.