A critical cGMP requirement is the establishment of controls to ensure quality and safety of investigational drug products, 9 including comprehensive quality systems that apply to all aspects of ...
Translating knowledge of genetic disease mechanisms into gene therapies has been slow with limited clinical success. One major reason is that the transfer vectors, which are most often of viral origin ...
Viral vectors dominate gene therapy, with lentivirus, adenovirus, and AAV being key players, each with unique advantages and limitations. Non-viral vectors, such as lipid nanoparticles and GalNAc, ...
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