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With the progress of live biotherapeutics development, multiple microbiome or probiotics have been extensively applied for the prevention and treatment of human diseases and conditions. Currently, an increasing number of preclinical and clinical trials are underway to assess the therapeutic potential and safety of new probiotics, especially those gene engineered probiotics that do not have a long history of safe use. Probiotic microorganisms are directly orally administrated into the human body to provide a variety of beneficial and therapeutic effects. Some probiotics must be intestinal environmental resistant and antibiotic-resistant to achieve the desired therapeutic effect, which requires high safety to ensure that there will be no potential safety hazard to the body. Furthermore, the safety assessment of live biotherapeutics products in high-risk populations, such as immunocompromised individuals, deserves special attention.
With the progress of live biotherapeutics development, multiple microbiome or probiotics have been extensively applied for the prevention and treatment of human diseases and conditions. Currently, an increasing number of preclinical and clinical trials are underway to assess the therapeutic potential and safety of new probiotics, especially those gene engineered probiotics that do not have a long history of safe use. Probiotic microorganisms are directly orally administrated into the human body to provide a variety of beneficial and therapeutic effects. Some probiotics must be intestinal environmental resistant and antibiotic-resistant to achieve the desired therapeutic effect, which requires high safety to ensure that there will be no potential safety hazard to the body. Furthermore, the safety assessment of live biotherapeutics products in high-risk populations, such as immunocompromised individuals, deserves special attention.