Chapter 20. Facilities for Large-Scale Production of Vectors under GMP Conditions

Summary

Good Manufacturing Practice is one part of the quality assurance system required in the production of medicinal products. In the European Union, the relevant conditions are covered by the ‘Orange Guide’; these include personnel, premises and equipment, documentation, production, quality control and self-inspection. Other European Directives cover the use of genetically modified organisms and recombinants. Most gene therapy products cannot be terminally sterilised therefore aseptic operations are required throughout. Viral vectors are grown in cultured mammalian cells using a variety of techniques. Master virus and/or plasmid banks must be created and monitored regularly. Equipment should be designed and maintained to suit the intended purpose, then validated according to a Master Validation Plan. Documentation procedures should ensure the traceability of all starting materials using a standard format throughout. Designing a suitable building for a production facility is a major undertaking and flexibility will be a key to success.