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Oncorine™ contains a deletion in E1B 55K region, which restricts the virus to bind and inactivate wild-type p27 protein. Inactivation of the host cell p27 is essential for wild-type adenoviruses to disable the activation of apoptotic pathway when host cell shifts to S phase in the oncolytic infection.
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US FDA defines gene therapy as products "that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms. The products may be used to modify cells in vivo or transferred to cells ex vivo prior to administration to the recipient."
Gene therapy is an experimental technique that uses proteins to treat or prevent disease. It targets the faulty genes responsible for genetic diseases.
European Medicines Agency (EMA) defines 'Gene Therapy Medicinal Products (GTMPs)' as: "generally consist of a vector or delivery formulation/system containing a genetic construct engineered to express a specific transgene ('therapeutic sequence') for the regulation, repair, replacement, addition or deletion of a genetic sequence. The active substance is the nucleic acid sequence(s), or genetically modified microorganism(s), virus(es) or cells."
EMA defines that a gene therapy medicinal product is a biological medicinal product which fulfills the following two characteristics: (a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; (b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
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