YM BioSciences says that the manufacturing facility for nimotuzumab, the company’s humanized mAb for the treatment of cancer, has been successfully scaled up to a 500-L capacity continuous perfusion fermentation process.
“The 500-liter capacity fermentation process is sufficient for the initial commercialization of nimotuzumab,” notes David Allan, chairman and CEO of YM BioSciences. “This drug is also being manufactured for other licensees at Biocon Biopharmaceuticals, a subsidiary of Biocon in Bangalore, and at Biotech Pharmaceuticals in Beijing, where production is anticipated to start shortly.”
YM also reports that Health Canada issued a No Objection Letter for the product manufactured at the 500-L capacity to be used in clinical trials in Canada. A regulatory authority in the EU has also inspected and certified the manufacturing process and infrastructure at the Center for Molecular Immunology. A further increase in capacity to 1,000-L scale continuous fermentation is also anticipated to be completed in 2007.
Nimotuzumab is produced in a continuous process using a stirred tank perfusion bioreactor. This method delivers higher capacity than batch production in bioreactors of the same size, according to the company.