XBiotech (XBIT) Announces Completion of EMA GMP Inspection; Facility Recommended for Xilonix Production
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XBiotech Inc. (Nasdaq: XBIT) announced a successful GMP (Good Manufacturing Practices) inspection by the European Medicines Agency (EMA). The EMA’s Competent Authorities of France [The French Agency for the Safety of Health Products], conducted the inspection in connection with the Xilonix Marketing Authorization Application. XBiotech’s production operations were deemed to be in general compliance with the principles and guidelines of good manufacturing practice as laid down in Commission Directive 2003/94/EC. The findings allow the French Agency to recommend to the EMA XBiotech’s current facility for the commercial manufacture of Xilonix.
XBiotech is pioneering a new manufacturing process using disposable bioreactor technologies. These manufacturing technologies reduce capital costs and operating complexity while improving flexibility of biological manufacturing compared to existing clean-in-place technologies. XBiotech CEO, John Simard, commented, “The confirmation of GMP compliance is an important step for our manufacturing platform and commercialization capabilities.”
The GMP inspection was performed as part of the evaluation of the Company’s Marketing Authorization Application for Xilonix for the treatment of advanced colorectal cancer. The Company expects EMA decision on the Marketing Application as early as the end of 2016.
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