Morovic and colleagues survey analytical testing under cGMP that are crucial to ensure the efficacy and safety of gene therapies. Methods like quantitative PCR are used to detect various nucleic acid-based characteristics of gene therapies, vectors, and their associated production elements and necessitate stringent development and validation.
All Keywords
【저자키워드】 artificial intelligence, Gene therapy, Regulatory, droplet digital PCR, Next-generation sequencing, quantitative PCR, adeno-associated virus, good manufacturing practices,
【저자키워드】 artificial intelligence, Gene therapy, Regulatory, droplet digital PCR, Next-generation sequencing, quantitative PCR, adeno-associated virus, good manufacturing practices,