Recommendations for successful quality assurance of production of bulk drug substances for non-viral gene therapy

✍ Scribed by Wolfgang Kuhne; Konrad Zöllner

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 128 KB
• Volume: 2
• Category: Article
• ISSN: 1087-8378
• DOI: 10.1002/(sici)1099-1786(199709)2:3<129::aid-qaj45>3.0.co;2-n

✦ Synopsis

The quality assurance concept for GMP production of non-viral bulk drug substance for use in gene therapy is briefly summarised in the following paper. The term 'non-viral gene therapy product' is generally used for therapeutical plasmid DNA. Plasmid DNA is regarded as a 'biologic'. Without additional application, purified plasmid DNA has no competence of cell transfection, self replication or of integration into the host cell genome. Therefore, no special safety requirements have to be considered. The safety requirements for the production process of plasmids are comparable with the requirements that have already been developed and applied for the production of therapeutic proteins, e.g. monoclonal antibodies, cytokines, etc.