FDA completes inspection of anthrax vaccine plant; company expects approval

Dec 21, 2001 (CIDRAP News) – The Food and Drug Administration (FDA) has completed a new inspection of BioPort Corp., the only US manufacturer of the anthrax vaccine, and a company official is predicting approval of the facility after a few remaining concerns are ironed out.

In an inspection that was completed Dec 19, the FDA noted seven problems that needed correcting at the Lansing, Mich., plant, according to an FDA news release. "BioPort satisfactorily addressed many of these observations during the inspection," the release says. The agency will make a decision on the company's "Biologics License Application" after the company responds to the remaining concerns, officials said.

BioPort President Bob Kramer, in a statement on the company Web site, said the company has 15 days to respond to the FDA's inspection report. "Once these items are addressed to the FDA's satisfaction, we believe we can anticipate facility approval." The company released a copy of the FDA inspection report.

Before vaccine can be released for shipment, however, the FDA must also approve a supplemental license for BioPort's contract-filling facility, Hollister-Stier Laboratories, the agency said. An FDA inspection of that facility is planned for early January, officials said.

The FDA had listed a large number of problems in a first inspection of the renovated BioPort plant in November 1999. The company said that "significant observations related to process validation and sterility assurance" during that inspection have since been resolved. "We believe we were able to clearly demonstrate to the FDA our ability to manufacture anthrax vaccine in a controlled and compliant environment," Kramer said.

BioPort renovated the plant after taking it over >from the state of Michigan several years ago. The company has not been able to sell anthrax vaccine because it lacked FDA approval for the completed renovation. BioPort supplies the vaccine to the US military, which launched a program in the late 1990s to vaccinate all service personnel. But because of a shortage of vaccine, last year the program was trimmed to focus only on those at greatest risk.

The Department of Health and Human Services announced this week that it was acquiring 10,000 doses of anthrax vaccine made in the renovated plant so they can be offered to people who were exposed to anthrax in the recent attacks by mail.

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