FDA approves MedImmune's vaccine production facility in UK
MedImmune, headquartered in Maryland, US, says the US Food and Drug Administration (FDA) has approved its new influenza vaccine manufacturing facility in Speke, UK. The facility can produce up to 15 million bulk doses a month of the trivalent, intranasal influenza vaccine, FluMist.
MedImmune, headquartered in Maryland, US, says the US Food and Drug Administration (FDA) has approved its new influenza vaccine manufacturing facility in Speke, UK. The facility can produce up to 15 million bulk doses a month of the trivalent, intranasal influenza vaccine, FluMist.
Bernardus Machielse, senior vice-president, operations at MedImmune said the facility will enable the company to ramp up production of FluMist and the 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 that of the company's existing manufacturing facility in Speke, and features larger testing and storage facilities, as well as automated inoculation capabilities. It employs a new filtration process that is expected to provide greater sterility assurance during bulk production.
The company plans to begin manufacturing FluMist at this site in 2006.