FDA Approves MedImmune's State-of-the-Art Influenza Vaccine Manufacturing Facility

GAITHERSBURG, Md. -- MedImmune, Inc. announced today that its newly constructed influenza vaccine manufacturing facility in Speke, England has been approved by the Food and Drug Administration (FDA). The facility allows MedImmune to produce up to 15 million bulk doses per month, or approximately 90 million bulk doses per influenza manufacturing season, of its trivalent, intranasal influenza vaccine, FluMist (Influenza Virus Vaccine Live, Attenuated).

"The approval of our new manufacturing facility demonstrates MedImmune's ongoing commitment to being a worldwide leader in the influenza vaccine market," said Bernardus N.M. Machielse, Drs., senior vice president of operations. "With this state-of-the-art facility, we can substantially ramp up production. It provides the capacity for manufacture of increased supply of FluMist and our investigational, next-generation influenza vaccine, known as CAIV-T (cold adapted influenza vaccine, trivalent). The facility could also be used to produce vaccine year round in the event of an influenza pandemic."

The square footage of the new facility is 10 times larger than MedImmune's existing bulk manufacturing facility in Speke, and features larger testing and storage facilities, as well as automated inoculation capabilities. The facility uses a new filtration process, which is expected to provide greater sterility assurance during bulk production. MedImmune plans to begin manufacturing FluMist at this site in 2006.

Source: MedImmune, Inc.