North American Biologicals Inc. (NABI) of Miami said that itsimmune therapy division has built a pilot laboratory toproduce clinical trial quantities of NABI's proprietaryformulation of HIV immune globulin (HIVIG) according to GoodManufacturing Practices complying with FDA regulations. NABIhas also applied for a special FDA license to qualify its CoconutGrove, Fla., plasma collection site to collect and process HIV-positive plasma.
NABI hopes to prove through clinical trials that its HIVIG canprevent the transmission of AIDS from HIV-positive mothers tounborn infants. HIVIG is prepared from the plasma of HIV-antibody-positive donors who are healthy and have a strongimmune response to the virus, the company (NASDAQ:NBIO)said.
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