Founded in 1970, BioVectra is a CDMO with specialties in microbial fermentation, complex chemistry and biologics. The company is looking to bolster its mRNA manufacturing capability.
In November 2021, the Canadian company announced its intent to build a new $79.6 million facility dedicated to producing and manufacturing mRNA vaccines and therapeutics. The initiative resulted from a joint private-public investment from the company and federal and provincial governments in Canada.
In April, BioVectra broke ground on the 36,000 ft2 mRNA Vaccine and Biomanufacturing Center located at its campus in Charlottetown, a city on Prince Edward Island.
The funding from the Canadian government followed after officials reached out to BioVectra with the intent of building up domestic manufacturing capability for mRNA- and plasmid-DNA-based vaccines.
Government officials ultimately decided to invest in BioVectra’s expansion, which will be structured into three phases, according to the company’s chief science officer Marc Sauer, Ph.D.
The first phase involves expanding its single-use bioreactor capacity in an existing dedicated biologics facility in Windsor, Nova Scotia. The company is adding 100- and 1000-liter scale bioreactors at that facility. “I believe the 1000-liter capacity will be one of the first for North American CDMOs,” Sauer said. BioVectra supports bioreactors as small as 1 liter and as large as 17,000 liters as part of its service offering. “We have everything in between,” Sauer said.
BioVectra aims to complete construction of the Windsor single-use clinical-scale microbial suite this summer.
Marc Sauer
The second part of the investment will focus on ramping up BioVectra’s process development capabilities. “We’re expanding our footprint in Prince Edward Island as well as in Nova Scotia, and we’re moving into new facilities in both provinces,” Sauer said. “We are extremely excited about the research and development facility in Halifax, Nova Scotia because this brings us closer to the universities in that area.” The first portion of this phase will entail a 16,000 ft2 expansion with “the opportunity to double that over the next three years,” Sauer added. The expanded facility will be the home of BioVectra’s Center of Excellence for biologic therapeutics such as plasmid DNA (pDNA) and mRNA. Plasmid DNA is an important ingredient involved in the manufacture of mRNA therapeutics and vaccines.
The projects will also allow the company to add capabilities such as cell banking, cell-line development and gene editing. Biovectra also plans on adding developing and manufacturing nucleic acids and adding capacity for microbial protein and other biotherapeutics via microbial fermentation.
In Charlottetown, BioVectra is building a facility that can enable production of up to 160 million doses of mRNA vaccines per year and prepare and package 70 million fill-finish doses per year for commercial distribution. The doses could either be for vaccines or therapeutics.
The company’s traditional focus is on clinical-to-commercial scale production capabilities with expertise related to synthetic and fermented small molecules, potent APIs, biologics and bioreagents.
When asked about mRNA’s potential beyond COVID-19 vaccines, Sauer is optimistic. “This is my opinion, of course, but I truly believe that this is a very disruptive technology,” he noted. “When you look at CRISPR and other personalized medicines that have been developed, they’re still fairly expensive and a bit more complicated than what mRNA production can offer.”
Sauer is confident that mRNA and pDNA technology in the coming years will provide an alternative to a number of existing therapies. “I think this will be a growing market. There’s a lot of investment currently being placed in development activities,” he said.
The technology also has few limitations in terms of what it can accomplish. Oncology and autoimmune disorders could be two of the next areas outside of vaccines to benefit from mRNA technology. “mRNA has the potential to knock out genes as well,” Sauer said. “If there’s a genetic disorder, this technology can help flip the switch again so that people suffering from autoimmune diseases can live a normal life again.”
A 2018 paper in Pediatric Allergy and Immunology noted that plasmid DNA and mRNA vaccines encoding allergens can “induce T helper 1 as well as T regulatory responses, which modulate or counteract allergic T helper 2–biased reactions.” They thus could hold potential for food allergy treatments. “There are some interesting clinical trials out there that show successful data when it comes to using mRNA against food allergies,” Sauer said.
mRNA also has economic advantages, given that mRNA doses are so small, and manufacturing processes related to it are relatively straightforward. “With mRNA, you don’t need to make crazy amounts in order to serve a large patient population,” Sauer said. “About 20 kilograms of mRNA could probably serve the entire global population.”