A proven partner
Highlights from our discussion with Heather Delage, Chief Commercial Officer at BIOVECTRA.
Supply and logistics
The location of a CDMO is always an important consideration by any sponsor organization considering its manufacturing strategy. BIOVECTRA’s facilities are located across several Eastern Canadian provinces – an area rich in fundamental science and engineering programs, and highly supportive of the bioscience industry.
“We are physically positioned well in terms of North American supply and logistics, but also globally,” says Heather. “For instance, Health Canada maintains Mutual Recognition with other global regulators such as EMA.”
BIOVECTRA has maintained regular audit history with Health Canada, the US FDA and Japan’s PMDA. The company has considerable experience in supplying and managing complex supply chains for products with specialized categorizations (such as HPAPIs and controlled substances), and those with varying physical requirements such as cold chain management or specialized volumes and packaging.
Heather says that the BIOVECTRA team sees themselves as continuing to grow, in tandem with their client partners, solving complex problems and demonstrating a unique culture of care as programs progress through the clinic toward commercialization.
Addressing complex challenges
As BIOVECTRA becomes Canada’s first CDMO to offer single-use microbial fermentation at the 1,000L scale, it is interesting to consider how the company has evolved over its 50-year history. BIOVECTRA thrives on continually developing its capabilities and inspiring its expert teams to support customers – often taking on the challenges that few other CDMOs would have the expertise or desire to address.
In terms of addressing complex customer challenges, Heather shared two recent examples.
“One of our biologics clients with an unusually complex supply chain had a fermented small molecule that required conjugation to their protein,” she explains. “Our team of experts identified flow chemistry as a potential scalable and safe way to synthesize their molecule. We’re nearing completion of our proof of concept with them and anticipate performing scale-up activities later this year. In addition, we have offered to further streamline their supply chain by producing the MPEG that their large molecule requires. This will reduce their supply network from three vendors to one, with BIOVECTRA making a protein, small molecule, and MPEG for the same program.”
She continues, “Another client came to us with a newly designed route for a controlled substance in pre-clinical development. Our team of scientists and regulatory experts identified several problems with their route, in terms of operational issues. We proposed a new synthetic route that would avoid those pitfalls. Within 15 months, we’d implemented the route and optimized and scaled it to produce their first two GMP batches.”
These are two great examples of how, with its end-to-end capabilities, facilities and equipment, BIOVECTRA is able to meet difficult challenges head-on. It is in the company culture to problem-solve, and to plan the next investments in view of current partners’ and clients’ requirements.
Current investment
One such investment that is taking place at the moment is a state-of-the-art mRNA vaccine and bio-manufacturing facility, as well as some new microbial fermenters, all of which should be operational later this year. These new laboratory facilities will have GMP capabilities for mRNA drug substance production by early 2023, and finished drug capabilities by the second half of 2023.
“With this facility, we’re thrilled to be able to make the production of plasmid DNA and mRNA products a reality in Canada, for our global customers,” says Heather. “This is a natural extension of our relevant experience producing both biologic and synthetic molecules, including very complex fermentation, and commercial supply experience with chemistries used in mRNA molecules such as MPEGs, lipid nanoparticles and entities like nucleic acids.”
The investment makes BIOVECTRA ready to serve global pharma customers with mRNA development programs or other novel therapies requiring plasmid DNA. It also provides an offering to emerging biotech developers looking for a proven partner who can move quickly; and Heather is quick to define what she means by a ‘proven’ partner, citing BIOVECTRA’s extensive experience in supplying commercial APIs and biologic drug substances.
“Whether for emerging or large pharma BIOVECTRA is an established, credible CDMO with the relevant skill sets, agility, and resources for integrated program delivery,” she concludes.
DCAT Week is the premier global event held annually in New York City for companies engaged in the Bio/Pharmaceutical manufacturing value chain. It is hosted by the Drug, Chemical & Associated Technologies Association (DCAT), a not-for-profit, corporate member-supported, and volunteer-led global business development association for companies engaged in the Bio/Pharmaceutical manufacturing value chain. Learn more at