Charlottetown, CANADA, October 31, 2022 – BIOVECTRA is ready to accept projects at its manufacturing facility in Windsor, Nova Scotia, Canada, for its new, single-use biologics fermentation suite. Containing 100 L and 1,000 L single-use fermenters, this state-of-the-art process train enhances BIOVECTRA’s microbial fermentation overall network of capacity and allows BIOVECTRA to support even more promising biologics for their tech-transfer and optimization, early and mid-stage clinical investigation, and even commercial scale supply of highly specialized therapeutics.
The addition of single-use fermentation capability provides BIOVECTRA customers with several benefits including greater flexibility, faster turnaround times, and increased capacity utilization. Additional benefits include a decreased risk of contamination, and the elimination of costly and time-consuming cleaning and sterilization between batches, which is essential with stainless-steel equipment.
“Our closed, sterile single-use fermenters are designed to provide mixing, oxygen transfer, and cooling capabilities comparable to stainless-steel bioreactors while being more agile and avoiding their fixed costs, which is a benefit many of our clients are eager to explore,” said Heather Delage, Chief Commercial Officer, BIOVECTRA. “As the demand for personalized therapeutics grows, single-use fermenters offer a unique solution and a huge advantage over stainless-steel fermenters with respect to batch segregation and cross-contamination risks.”
“Companies that want to start a clinical program and take it to commercial launch are no longer faced with an either/or choice of single-use versus stainless-steel fermenters,” Delage continues. “The combination of the two can be ideal for those engaged in clinical-to-commercial scale production. Clients could begin with single-use fermenters for production of biologics needed for development, early-phase clinical trials, and orphan indications. Then, for large-scale production of successful drug products, BIOVECTRA can support the transition to larger stainless-steel fermenters (e.g., >3,000 L up to 17,000 L, or larger) to manufacture enough product for phase 3 clinical trials and commercialization.”
BIOVECTRA is the first Canadian CDMO to offer single-use, microbial fermentation at the 1,000 L scale. This additional capacity enhances the company’s overall biologics asset network and continues to broaden its wide range of operating scale, which includes three process development labs (high-throughput multiplex systems at the 1 and 10 L scales), three early to mid-clinical scale production suites (suites from 100 L to 1,500 L vessel capacity), and two large scale production suites (with 10,000, 15,000, and 17,000 L fermentation production scales). This significant breadth of fermentation capacity is offered by a world-class CDMO with decades of experience in producing and supporting commercially marketed therapeutics.
Dr. Marc Sauer, Chief Science Officer for BIOVECTRA, stated, “Our skilled fermentation process science team is ready to tackle your next challenge, and we are very excited to utilize single-use technology to help clients achieve the speed and efficiency they need for their important programs.”
BIOVECTRA is a global biotech and pharmaceutical CDMO (contract development and manufacturing organization) that specializes in clinical-to-commercial scale production capabilities for: biologics, small molecules, bioreagents, and pDNA and MRNA manufacturing. Flexibility, creativity, process optimization and compliance are at the heart of our method. With more than 50 years of experience, over 550 employees, and cGMP facilities in Prince Edward Island and Nova Scotia, Canada we assure our programs advance on time and with the highest quality outcomes.
Media Contact: Valerie Keays, Director of Marketing, [email protected]