Transgenic animal-derived human therapeutics should undergo pathogen safety assurances -- FDA "PTC".
TRANSGENIC ANIMALS: PATHOGEN SAFETY ASSURANCES SHOULD BE DEVELOPED by manufacturers for final products to be derived from the production of transgenic animals, FDA states in its first "Points to Consider" document on transgenics issued Aug. 24 and announced in a same-day Federal Register notice. "Transgenic animal source materials have the potential to contain a variety of human pathogens (e.g., viruses, bacteria, mycoplasma, transmissible spongiform encephalopathy agents)," the document declares. "For this reason each manufacturer should develop analytical methods and purification processes that can ensure the safety of the product."
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