Facility in face-off with FDA to revive manufacturing privileges of anthrax vaccine, lack of cGMPs to blame

12/01/2001

Meg Villeneuve

LANSING, MI—To date, there isn't one facility 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 not maintaining current good manufacturing practices (cGMPs.)

Since the September 11th attacks and the anthrax threats sent to news media and the US government, 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 Corp.

It is likely that the FDA will inspect BioPort's facility by mid-December. However, approval may take as much as six months, according to a spokesperson for BioPort.

During the second half of 1998, BioPort purchased the Lansing, MI-based facility from the Michigan Biologics Products Institute (MBPI). 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 (WSJ), the FDA says it is moving quickly to inspect BioPort's facility, and hoped to do so by the middle of last month.

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 a strategic plan for compliance.

When the FDA returned to the facility in 1998, "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 particle 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,"says Jan Eudy, technical VP of contamination control for the Institute of Environmental Sciences and Technology (IEST.)

"For example, the types of filters and fermenters used in the plant were switched in 1990 and 1993 to increase production capabilities. But no tests were done to determine if those changes altered the vaccine being produced," explains Nancy Kingsbury of the General Accounting Office when she spoke to a congressional subcommittee on national security.

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 discuss the situation with CleanRooms magazine. However, a spokesperson from the Department of Health and Human Services told the WSJ, "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.