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    Home > Active Ingredient News > Drugs Articles > FDA approves genetically engineered modified pig that could be used to produce potential human therapies

    FDA approves genetically engineered modified pig that could be used to produce potential human therapies

    • Last Update: 2020-12-26
    • Source: Internet
    • Author: User
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    The FDA announced it has approved the listing of a home pig, known as GalSafe, that is intended to alter the genome.
    this kind of pig may be used for food or human treatment.
    fda's first FDA-approved animal to be used for both human food consumption and as a potential source of therapy, according to a press release.
    the genome of GalSafe pigs is designed to eliminate the expression of pig cells on the surface α-semi-lactose.
    α-semi-lactose is the main cause of acute immune rejection in allogeneic organ transplantation.
    use of pig organs to alleviate the shortage of transplanted organs is the direction developed by several biotech companies.
    For example, eGenesis, co-founded by Professor George Church of Harvard University and synthetic biologist Dr. Yang Wei, and a letter-starting organism co-founded by Dr. Yang Wei in China, are using CRISPR gene editing to develop pigs suitable for human transplant organ donors.
    galSafe pig was developed by Revivicor, a united Therapeutics company, to address the acute immune rejection problems that can be caused by tissues and organs from pigs.
    genetically engineered, the company knocked out proteases that add α-semi-lactose to the surface of pig cells, so that pig cells no longer express α-half lactose.
    GalSafe pigs may be used to produce the blood-thinning drug heparin, which does not contain α-semi-lactose for human use and does not contain α-semi-lactose.
    as part of a review that genetically engineered pig cells to stop expressing α-semi-lactose, thereby reducing acute immune rejection (Photo: Revivicor's official website), the FDA evaluated the safety of genetic engineering in animals and people who eat their meat, and whether it eliminated α-half lactose from pig cells.
    FDA determined that Food based on GalSafe pigs is safe for the general population to eat.
    the FDA's data showed that no 100-half lactose α been detected in multigenerational GalSafe pigs.
    . Stephen M. Hahn, DIRECTOR of the FDA, said,
    Today's FDA approval of a biotech animal product that can be used as a potential source of both food and biomedical therapies represents a huge milestone in scientific innovation.
    as part of our public health mission, the FDA strongly supports the promotion of innovative biotechnology animal products that are safe for animals, safe for humans, and achieve the desired results.
    press release also noted that the FDA has not evaluated the pigs for use as heterogeneity transplant products or implanted in human subjects.
    developer must first submit an application to the FDA and obtain approval before these products can be used in human medicine.
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