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EMA GMP inspection successfully completed for XBiotech (XBIT)

The EMA’s Competent Authorities of France (The French Agency for the Safety of Health Products), conducted the inspection of XBiotech Inc. in connection with the Xilonix Marketing Authorization Application and the company has successfully completed the GMP inspection.

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’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.


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