Development of retroviral-based gene therapy products: a quality control perspective

✍ Scribed by Nancy Sajjadi

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 108 KB
• Volume: 2
• Category: Article
• ISSN: 1087-8378
• DOI: 10.1002/(sici)1099-1786(199709)2:3<113::aid-qaj47>3.0.co;2-q

✦ Synopsis

Gene therapy holds much promise for the treatment of many human diseases. Research focused on improving vector delivery systems, identifying therapeutic genes and designing effective treatment regimens, continues. Meanwhile, many first generation gene therapy products are being evaluated in early phase clinical trials. As development continues towards a product licensure, considerable effort must be dedicated to designing facilities and processes that will allow for product manufacture and testing in accordance with Federal Regulations. This article provides a broad overview and brief history of quality control considerations in the development of retroviral-based gene therapy products.