Source https://www.fightaging.org/archives/2025/09/bringing-affordable-vegf-gene-therapy-to-medical-tourism-clinics/
Many classes of therapy can be robustly manufactured with little risk of issues and do not need the full cost in time, effort, and funds of Good Manufacturing Practice (GMP) specified by the FDA in order for any given batch of the drug to be demonstrated to be safe. The most frequently used AAV vector serotypes, for example, are relatively safe in this way. One can manufacture a batch of an AAV drug with any one of the very experienced manufacturers in the same way one would for research in animals, and then run all of the quality assays needed to demonstrate that the batch is safe. This costs a lot less than full GMP but should produce essentially equivalent outcomes in safety.
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Source https://www.fightaging.org/archives/2025/09/bringing-affordable-vegf-gene-therapy-to-medical-tourism-clinics/
Many classes of therapy can be robustly manufactured with little risk of issues and do not need the full cost in time, effort, and funds of Good Manufacturing Practice (GMP) specified by the FDA in order for any given batch of the drug to be demonstrated to be safe. The most frequently used AAV vector serotypes, for example, are relatively safe in this way. One can manufacture a batch of an AAV drug with any one of the very experienced manufacturers in the same way one would for research in animals, and then run all of the quality assays needed to demonstrate that the batch is safe. This costs a lot less than full GMP but should produce essentially equivalent outcomes in safety.
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