Biovectra to Build First mRNA Vaccine and Drug Manufacturing Plant in Canada

Biovectra to Build First mRNA Vaccine and Drug Manufacturing Plant in Canada

Canadian pharma and biotech CDMO Biovectra has received funding from provincial (PEI) and federal governments in Canada for expansion of its biomanufacturing facilities to enable production of mRNA vaccines.

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. The $79.6 million project received funding from the province of Prince Edward Island (PEI) in Eastern Canada, where the facility will be built, and the Canadian federal government in amounts of $10 million and $39.8 million, respectively.

The investment will go towards expanding Biovectra’s existing production facility in Charlottetown, PEI. The expansion will include a new 30,000-square-foot building that will be able to produce 160 million doses of an mRNA vaccine per year, and up to 70 million prepared and packaged fill finish doses for commercial distribution annually. Additional production would be performed at other facilities for final packaging.

Construction of the new manufacturing plant is scheduled to begin in March next year, with production anticipated to begin at the facility a year later.

The reliance of COVID-19 vaccine manufacturing on only a handful of countries globally has made many nations realize the need for large-scale, domestic biomanufacturing facilities for drugs and vaccines as preparation for potential disease outbreaks and health emergencies in the future.

Biovectra is a global CDMO that focuses on clinical-to-commercial scale production capabilities for biologics, bioreagents, synthetic small molecules, fermented small molecules and active pharmaceutical ingredients (APIs), including highly potent APIs, among others. The company has over 550 employees with cGMP facilities in PEI and Nova Scotia, Canada.

Related: Medicago’s Plant-Based COVID-19 Vaccine Enters Human Trials

Biovectra is not new to biomanufacturing as it has been around for several decades in Canada. In a press release from the company, Biovectra CEO Oliver Technow said, “Biovectra is well poised to make the production of mRNA therapeutics in our country a reality. As a leading Canadian CDMO, with more than 50 years of expertise, we have a proven record of pushing the boundaries of our capabilities to meet our global customers’ challenges. This expansion is a significant yet natural evolution for us.”

“At Biovectra, we aim to be a global leader, bringing Canadian innovation to the center stage of biopharmaceutical manufacturing,” said Technow. “We understand our obligation to not just manufacture mRNA, pDNA, and provide an end-to-end manufacturing solution domestically, but to also demonstrate to the world that innovation and talent lives here in Atlantic Canada.”

The CDMO’s new manufacturing facility will have the capability to develop and manufacture nucleic acids, recombinant proteins and therapeutics expressed via microbial fermentation.

During the pandemic, the Government of Canada acknowledged recent shortcomings in the life sciences and biomanufacturing sectors. This left the country without production capabilities for large-scale manufacturing of COVID-19 vaccines. As such, the federal government  is putting in major effort to build Canada’s domestic biomanufacturing sector “by focusing on both quick strategic actions and a long‑term vision,” according to a from the Government of Canada. The government also stated it has invested over $1.2 billion to rebuild Canada’s vaccines, therapeutics and biomanufacturing capacity.

“Vaccines save lives, and COVID-19 vaccines are helping us start getting back to normal. Biovectra’s plan to establish a state-of-the-art vaccine facility here in Prince Edward Island, and upgrade their existing facilities in Nova Scotia, is a key move that supports our strategy to grow a strong, competitive domestic life sciences sector with cutting-edge biomanufacturing capabilities. This will make sure Canada is prepared for future pandemics and other health emergencies, strengthen our economy and create good jobs here in Atlantic Canada,” said the Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry.

Canada’s National COVID-19 Vaccine Projects

The Canadian government has also provided $173 million in funding to Medicago, a biotech company based in Montréal, Québec, which is working to develop a plant-based COVID-19 vaccine in partnership with GlaxoSmithKline (GSK). The funding is going towards vaccine research and development as well as construction of a manufacturing facility in Québec City. The vaccine demonstrated positive Phase II trial results and is currently in Phase III testing. If all goes well, it could become Canada’s first domestically developed COVID-19 vaccine.

In addition to the investments into home-grown Biovectra and Medicago, Canada also has plans to manufacture its own doses of Maryland-based Novavax’s anticipated protein subunit COVID-19 vaccine in 2022 at the National Research Council of Canada’s Biologics Manufacturing Centre in Montréal, pending its authorization. Once up and running, federal officials say the facility could produce 24 million doses of vaccine per year. The two-dose shot has so far only been authorized for emergency use in Indonesia and the Philippines. At the beginning of the month, the company completed a rolling submission to Health Canada seeking approval for the vaccine in Canada.

The need for COVID-19 vaccines is anticipated to continue considering waning immunity and increasing case numbers, prompting health regulators around the world to recommend boosters for some groups of people, and even the general public. On Friday, the US Food and Drug Administration (FDA) expanded eligibility of both Pfizer and Moderna COVID-19 boosters to individuals 18 years of age and older.

These efforts will pave the way for Canada to be able to produce its own COVID-19 vaccines for the very first time since the beginning of the pandemic, and other vaccines and drugs at large-scale in the future.

Biovectra is also working to strike research partnerships and look for new development opportunities for life science professionals and those in the field of biomanufacturing. This will include the addition of 125 new positions at the company’s PEI and Nova Scotia sites along with up to 225 co-op terms, according to the company. The Windsor, Nova Scotia site will also undergo expansion to support the development and production of plasmid DNA (pDNA), which is key to the manufacturing of mRNA vaccines and therapeutics.

In total, Biovectra has five accredited facilities across Canada’s eastern seaboard.

“Biovectra is excited about our new mRNA vaccine and biomanufacturing facility that will be part of the Canadian solution to building the domestic vaccine production capability crucial to protecting Canadians’ health in the face of a future health crisis. As a globally recognized Canadian anchor company in life sciences, Biovectra brings the experience and biomanufacturing know-how needed to produce mRNA and pDNA vaccines. Today’s joint investment [with the Canadian government] accelerates Atlantic Canada’s fast-growing bioscience sector and strengthens the Canadian biomanufacturing ecosystem,” said Technow.