1. Scope
The scope will cover the sourcing, testing, and clinical monitoring important for ensuring the adventitious agent safety of xenogeneic tissue engineered medicinal products. It will cover not only measures for ensuring the safety of the product prior to clinical studies, but also what controls and/or monitoring necessary for ensuring that such products do not result in the introduction of new pathogens into the population.
The standard is necessary to provide clear guidance to manufacturers and clinicians which ensure the pathogen safety of the product, as the safety of the general population by defining procedures which minimise the risk of novel viruses into the population.
Keywords
Adventitious agent testing, biosafety testing, virus safety, mycoplasma, virus, xenotransplantation, xenogeneic gene therapy, pathogen safety
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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