Biosafety Issues in Lentivector Production
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The development of efficient lentivectors brings about exciting possibilities for novel therapeutic interventions. Still, as new biologicals intended to be used in the clinic, these vectors will have to comply with a complete set of requirements regarding their mode of preparation and characterization. Over the past 50 years, there has been an increasing awareness of the safety issues surrounding the manufacturing of medicinal products. Regulatory authorities and agencies regularly publish guidelines and coordinate international conferences on harmonization (ICH), whose goal is to define common standards for biotechnological and biological products to be administered to human patients (SCHULTZ 1998).
KeywordsCiency Virus Rous Sarcoma Virus Packaging System Human Immunode Gene Transfer Vector
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