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BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.
BioVectra, a Mallinckrodt Pharmaceuticals company and CDMO based in Canada, announced in a May 24, 2017 press release 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.
BioVectra’s $30-million investment has equipped the 50,000-ft2 facility with 40,000 L of fermentation capacity, downstream processing equipment, and new preclinical fermentation and potent chemistry suites. The new facility is an investment in BioVectra’s core development and manufacturing competencies: microbial fermentation and complex chemistries. 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 APIs, handling potent substances such as antibody-drug conjugate warheads, with occupational exposure limit 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.