WINDSOR, Nova Scotia--(BUSINESS WIRE)--BioVectra Inc., a Contract Development and Manufacturing Organization (CDMO) providing cGMP services to globally operated biotech and pharmaceutical companies, today announced that its fourth cGMP facility will be fully operational by December 2017. The late-stage to commercial-scale microbial fermentation and complex chemistry facility is located in Windsor, Nova Scotia, with proximity and service to Northeast USA development entities.
BioVectra’s $30 million investment has equipped the 50,000 square-foot facility with 40,000 liters (L) of fermentation capacity, downstream processing equipment and new pre-clinical fermentation and potent chemistry suites. “The investment strengthens our unique position in the very competitive global marketplace, enabling us to offer new and existing clients range of scale throughout the entire lifecycle of a product,” said Oliver Technow, BioVectra’s President.
The new facility is an investment in BioVectra’s core development and manufacturing competencies: microbial fermentation and complex chemistries. As an industry leader in microbial fermentation of both small and large molecules, the company provides scalable cGMP operations from 30 L to 17,000 L. BioVectra has the capability to handle the development and cGMP scale-up of high-potency active pharmaceutical ingredients (APIs), handling potent substances such as antibody-drug conjugate warheads, with occupational exposure limit (OEL) levels of < 20 ng/m3 (Safebridge Band 3 and 4).
The new facility increases BioVectra’s ability to partner with global pharmaceutical companies by offering dual-site risk mitigation. “This expansion helps BioVectra keep up with the growing demand for our products, while also meeting an underserved need for large-scale microbial fermentation in North America,” said Heather Delage, Vice President of Business Development. “In addition to the facility’s large-scale fermentation capability, the site also offers a complementary footprint for synthetic process development and laboratory-based activities.”
BioVectra’s three additional cGMP facilities and headquarters are located in Charlottetown, Prince Edward Island.
BioVectra is a CDMO that serves pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and APIs. An innovative and reliable partner with an impressive track record of long-term API supply and a strong quality history, BioVectra has over 45 years of experience specializing in:
- Microbial Fermentation
- Complex Chemistry
- High-Potency APIs
- Process & Analytical Development
- Drug Development
BioVectra is a wholly owned subsidiary of Mallinckrodt Pharmaceuticals.