BioPort to hire outside company

Lansing firm to seek help in packaging of anthrax vaccine

By Tim Martin and A.J. Evenson

Lansing State Journal

Tuesday, October 31, 2000

BioPort Corp. plans to hire a contractor to address one of its toughest challenges in winning government approval for its renovated anthrax vaccine labs.

The Lansing company is searching for a firm to bottle and package its vaccine - the aftermath of a general U.S. Food and Drug Administration inspection completed last week. It would be the second time in recent months BioPort has turned to an outsider for help while working toward FDA certification of its new anthrax vaccine labs.

A company official said Monday that FDA approval could come by mid-2001 - possibly a few months later than projected when the certification process began in August 1999.

"We've had a little slippage, but not much," said Mike Tanner, BioPort's director of corporate services. "We're optimistic we could see final approval by the middle of next year."

BioPort and the military's anthrax vaccination program have come under fire in Congress for delays in getting the FDA approval. Low supplies of the vaccine caused the Pentagon to delay its plans to inoculate all 2.4 million U.S. troops against the deadly biological weapon, possessed by Iraq and up to 10 other nations.

Some in Congress have called to end the anthrax vaccination program, or make the decision to take the drug voluntary, citing health concerns. But getting FDA approval would be crucial to long-term success for BioPort and its 200-plus Lansing employees if the program continues as the Pentagon plans.

For months, BioPort has considered getting outside help for its filling and packaging operations. The company cemented its decision after a general FDA inspection this month found 18 flaws in the Lansing operations - more than half connected to filling and packaging.

BioPort had hoped to fix its bottling and packaging operations in stages, while keeping it operational. But after last week's FDA report reinforced years of earlier criticism about the operation, company officials decided they'd be better off renovating the entire area at once - and hiring a outside contractor to package vials in the meantime. It could take BioPort a year or more to renovate and win federal approval for its filling and packaging area, company officials said.

Eventually, the anthrax vaccine could be bottled in two locations: one at BioPort and one off-site.

"The Department of Defense would like us to have a second filling site," Tanner said.

The Pentagon is also hunting for a second company to make the vaccine.

One potential second source is Battelle Memorial Institute - an Ohio-based defense contractor. BioPort recently hired Battelle to hire 14 managers and assist with key potency testing for the anthrax vaccine.

"In some respects, it's not surprising they're coordinating with other Department of Defense contractors," said Mark Zaid, a lawyer who has represented military personnel opposed to the anthrax vaccine. "It seems they're doing anything they can to survive."

The FDA inspection completed this month was a routine, facility-wide probe conducted every two years.

FDA spokeswoman Lenore Gelb would not specifically comment on the BioPort inspection Monday. But in general, routine inspections are evaluated further before final conclusions are made, she said.

That could include follow-up discussions and visits with the company before a final report is issued.

The general inspection is separate from a FDA visit that likely will come early next year, tied specifically to renovated anthrax vaccine labs.

In November 1999, FDA found 30 problems tied directly to the new labs. BioPort can't distribute any new vaccine until those problems are fixed.

The lab has fared worse in previous FDA inspections, mostly when it was state-owned. In March 1997, the FDA threatened to shut down the lab for quality control deficiencies and manufacturing violations.

BioPort bought the state lab - called the Michigan Biologic Products Institute - in 1998.

Controversy has continued under private ownership, primarily because of finances.

A year ago, BioPort received an $18 million cash advance from the Pentagon - the company's largest customer - for doses of the anthrax vaccine the military still hasn't received.

BioPort officials earlier this year said they expected the company would complete 2000 with an $18 million cash shortfall without additional help. The military now is paying about $2 million more a month to keep the company afloat while it works toward FDA approval of the renovated labs.

Contact Tim Martin at 377-1061 or tmartin@lsj.com or A.J. Evenson at 377-1015 or aevenson@lsj.com.

Published 10.31.00