Immune-system modulator, for managing HIV disease and the public health crisis
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CytoDyn has completed safety testing of Cytolin. Its an immune-system modulator for managing HIV disease and the public health crisis, afflicting communities where the infection is spreading due to unprotected sex and the other risk factors for AIDS.
Tests for specific adventitious agents and other quality parameters following purification were performed by the manufacturing facility, Vista Biologicals of Carlsbad, California. The other safety tests, including in-vivo general safety using two animal species, were performed by WuXi AppTec in facilities in St. Paul, Minnesota.
Since the product is intended for use in a clinical trial, the tests conducted were those required for each new batch of a biologic agent manufactured for use in human research. The company believes that the test results satisfy the current safety standards for the manufacturing of drugs belonging to the class of biologics.
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