News

Posted On: 11/08/2004

Chiron flu vaccine facility in the U.K. had history of aseptic manufacturing problems, article alleges

According to a news report published on November 7 in the Kansas City Star, Chiron's U.K.-based flu vaccine manufacturing plant in Liverpool, U.K., had a history of aseptic processing problems when it was operated by its former owner, Medeva.  Documents obtained by the newspaper's reporter Mike McGraw showed that, in 1999, FDA inspectors had noticed a number of deviations from good manufacturing practices at the facility. 

Chiron bought the facility from PowderJect, Ltd., which had acquired the plant from Medeva. Acccording to the article, inspectors found that Medeva plant staff had :

• mixed samples of contaminated vaccine with cleaner lots to reduce bacteria level
• raised limits for allowable contaminants
• failed to control air flow and other possible sources of contamination
• failed to produce critical documentation on manufacturing process problems.

In addition, the plant lacked alarms that would alert workers to bacteria entering through the heating and cooling system.  Inspectors noted that at least 21 batches of the vaccine distributed in 1999 had to be filtered more than once to remove bacteria such as E coli.

"To date, the evidence suggests that the source of microorganisms was the process equipment or materials [involved in production], rather than chance contamination from the environment," the article quotes from the report.

Sterilization had removed contamination from final product, but problems outlined in the article indicate that GMP problems that may have warranted closer scrutiny.  In fact, one source interviewed said, the practice of mixing clean and contaminated samples made the facility "a ticking time bomb" in which contamination could eventually reach the final product.

A group of Chiron shareholders recently launched a lawsuit alleging that the plant, which Chiron bought from PowderJect, Ltd. last year, had serious contamination problems and hadn't warned them or addressed them properly.

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