BioWhittaker is in talks with FDA over procedures Regulator concerned about how company ships live-cell product

October 13, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

BioWhittaker Inc. said yesterday that it is working with U.S. Food and Drug Administration officials to iron out the regulatory agency's concerns over procedures the company uses to prepare a live-cell product for shipment.

The company, which sells cell and tissue cultures and testing products for biotechnology research and manufacturing, also confirmed yesterday that it has laid off about 25 employees as a result of its 1997 purchase by Cambrex Corp. of East Rutherford, N.J.

Some of the laid off employees will not leave the Frederick County-based company until the end of the year. The layoffs represent about 6 percent of the company's pre-layoff work force of 420.

The employees who lost their jobs worked chiefly in accounting, legal affairs and other administrative positions, though a few manufacturing employees also lost their jobs.

Rohrer said the layoffs were tied to efforts to streamline operations as Cambrex and BioWhittaker merge computer systems that handle office functions.

Philip L. Rohrer, chief financial officer for BioWhittaker, said the FDA told the company in a warning letter earlier this month that it was concerned that the company was not using an FDA-approved test to screen the living-cell product for contamination before shipment.

Rohrer said the company had been using a test approved for use in Europe, but has switched to using the U.S.-approved test since receiving the FDA advisory. The FDA conducted an inspection of BioWhittaker's manufacturing and shipping facility this summer.

The Walkersville-based company is in talks with the FDA about other issues it raised about handling of the live-cell product after the inspection, Rohrer said.

"The bottom line is we are continuing to sell and ship the product, and are continuing our discussions with the FDA," he said.

The FDA was closed yesterday for the Columbus Day holiday.

Rohrer said the live-cell product, which is sold to biotechnology researchers and bio-pharmaceutical companies, is not a significant revenue generator, though he declined to be specific.

Prior to being purchased for $130.9 million in August 1997 by Cambrex, BioWhittaker had annual sales of $56 million.

Publicly held Cambrex specializes in supplying pharmaceutical firms with specialty chemicals for product development and manufacturing.

Pub Date: 10/13/98

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