BioVectra is ready to accept projects at its manufacturing facility in 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 optimisation, early and mid-stage clinical investigation, and even commercial scale supply of highly specialised therapeutics.
The addition of single-use fermentation capability provides BioVectra customers with several benefits including greater flexibility, faster turnaround times, and increased capacity utilisation.
Additional benefits include a decreased risk of contamination, and the elimination of costly and time-consuming cleaning and sterilisation 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 personalised 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.”
Our skilled fermentation process science team is ready to tackle your next challenge, and we are very excited to utilise single-use technology to help clients achieve the speed and efficiency they need for their important programs
“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 added. “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 commercialisation.”
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, said: “Our skilled fermentation process science team is ready to tackle your next challenge, and we are very excited to utilise single-use technology to help clients achieve the speed and efficiency they need for their important programs.”
