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NORA KOCHCryo-Cell International will relocate in preparation for stricter FDA rules for blood banks and for its future growth, company officials say.
CLEARWATER - Cryo-Cell International, a local company that stores newborns' umbilical cord stem cells for possible future medical use, plans to move to a larger, custom-built facility in Oldsmar this summer.
Cryo-Cell, which now stores more than 65,000 specimens, is moving in anticipation of new, more stringent federal regulations for blood banks and to accommodate growth, said Mercedes Walton, the company's chairman and interim CEO.
The new 18,000-square-foot facility in the Brooker Creek North section of the Tampa Bay Park of Commerce will include labs and clean rooms, where the company will be able to increase its use of "good tissue-manufacturing practices," Walton said. Cryo-Cell plans to vacate its current 12,000-square-foot facility on McMullen-Booth Road by the end of the year, she said.
Walton said the expansion is partly to prepare for expected new regulations from the FDA, which could require human cellular and tissue-based products to be manufactured in compliance with specific rules, including labeling and reporting requirements and guidelines for screening and testing for diseases.
Cryo-Cell, which has about 45 employees, will also move its clinical services, administrative and marketing operations to the new building.
In planning the expansion, the company factored in expected growth for the next 10 years, Walton said. The new facility will allow the blood bank to increase its capacity several times over. Cryo-Cell signed a 10-year lease with Harrod Properties of Tampa, which is developing the Tampa Bay Park of Commerce.
Cryo-Cell preserves newborn infants' umbilical cord blood at super-low temperatures in cryogenic freezers. The blood can be withdrawn and used to cure life-threatening diseases, such as leukemia. This month, the company plans to raise its fees of $595 plus $90 a year for storage by an unspecified amount.
The company relocated to Clearwater from Arizona in 1997. In January its board approved discontinuing use of a proprietary freezer once touted as giving the company a competitive edge.
After being delisted from the Nasdaq stock market in July, Cryo-Cell reported a profit for the quarter ended Feb. 29 because of an increase in fees for enrollment and storage, according to the company's latest earnings reports to the Securities and Exchange Commission. New specimens processed during the latest quarter were down 17 percent compared to the same period a year ago.
In a telephone interview, Walton said the company is on a sound footing.
"The bottom line is that the company is stable, strong and thriving," she said.
Walton would not disclose how much the company is investing in the building.
Cryo-Cell has submitted permits for the building to the city of Oldsmar, said Greg Scoville, director of the community development department.
- Times researcher Cathy Wos contributed to this report. Nora Koch can be reached at 727 771-4304 or nkoch@sptimes.com