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news.Canadian oncology company YM BioSciences has revealed that the manufacturing facility for its nimotuzumab cancer treatment has been successfully scaled up to a 500-liter capacity continuous perfusion fermentation process.
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The company commented that the 500 liter-capacity fermentation process is sufficient for the initial commercialization of nimotuzumab, a humanized monoclonal antibody for the treatment of cancer.
YM BioSciences, which made the announcement in conjunction with the company’s majority owned subsidiary CIMYM BioSciences, also reported that Health Canada has issued a no objection letter for the product to be used in clinical trials in Canada.
In addition, an EU regulatory authority has inspected and certified the manufacturing process and infrastructure at the Center for Molecular Immunology.
“This drug is also being manufactured for other licensees at Biocon Biopharmaceuticals Limited, a subsidiary of Biocon in Bangalore, India, and at Biotech Pharmaceuticals in Beijing, China, where production is anticipated to start shortly,” said David Allan, chairman and CEO of YM BioSciences.
YM BioSciences expects a further increase in the manufacturing capacity to 1,000-liter scale continuous fermentation to be completed in 2007.