Introgen Receives European Certification of its Production Facilities
Advexin p53 anticancer therapeutic will be manufactured.
Gendux and Introgen Therapeutics say that they have been given the go ahead to produce its drug candidate for a variety of somatic and inherited cancer indications.
Introgen received certification from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and its facilities and production processes were found to be compliant with European Good Manufacturing Practices for the production of Advexin® p53 therapy.
After an audit and inspection of Introgen’s facilities, clinical certification by the MHRA was obtained so that Advexin can be made available to cancer patients in the E.U. Introgen will supply Gendux and its European marketing partners with Advexin.