Facility, FDA Face Off Over Manufacturing Privileges of Anthrax Vaccine

October 22, 2001 — LANSING, MI — To date, there isn’t one facility that is approved by the Food and Drug Administration (FDA) to manufacture the anthrax vaccine. That’s because three years ago, the only facility approved to manufacture was shut down by the FDA for shoddy good manufacturing processes (GMPs.)

“Companies have procedures in place to manufacture vaccines and are governed by the FDA,” says Jan Eudy, technical VP of contamination control for the Institute of Environmental Sciences and Technology (IEST.)

Since the September 11th attacks and the proceeding anthrax threats sent to news media and Congress, there is a heightened urgency for the vaccine to be produced again. At this time there is only one company that holds the license to manufacture the vaccine, BioPort Corporation.

During the second half of 1998, BioPort purchased the Lansing, MI based-facility from the Michigan Biologics Products Institute. Prior to that sale, MBPI halted the production of the anthrax vaccine to renovate its facilities to be in compliance with the FDA. Upon the purchase, BioPort agreed to follow the strategic plan put into place by MBPI.

According to a report in the Wall Street Journal, the FDA says it is “working closely with BioPort to resolve its problems.”

Originally, the facility and the license to manufacture the anthrax vaccine was owned by the Michigan Department of Public Health, which in 1996 became known as MBPI. During that same year the FDA inspected MBPI’s facility and found “numerous significant deviations from the Federal Food, Drug and Cosmetic Act, FDA’s regulations and the standards in MBPI’s license,” according to a report released by the FDA.

In 1997, the FDA issued a Notice of Intent to Revoke letter, which meant if MBPI did not comply with FDA standards it risked having the facility closed and the possibility of the vaccine seized. MBPI responded with strategic plan for compliance.

When the FDA returned to the facility, “the inspection disclosed significant deviations from FDA?s regulations,” according to the FDA. As a result, MBPI was forced to quarantine 11 lots of the anthrax vaccine that were thought to have possible problems with potency, sterility and particulate matter. “Now the company has to prove to the FDA that they can make a consistent batch over time and that they are meeting the standards,” Eudy adds.

In preparation for its subsequent submission of a Biologic License Amendment (BLA), BioPort began manufacturing consistency lots of the anthrax vaccine in May, 2000. The BLA is a requirement when any facility undergoes changes or renovations, according to a BioPort spokesperson.

At this time neither the FDA or BioPort were able to give an interview to CleanRooms Magazine. However, a spokesperson from the Department of Health and Human Services told the Journal, “Before September 11, the FDA expected that BioPort might come into compliance within three to four months. Now the goal is to have that happen within six weeks.” On October 12, BioPort submitted an amended BLA


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