Production of retroviral vectors for clinical use.
Retroviral vectors were the first viral vectors to enter clinical trials and continue to be attractive candidates for applications where integration of the transgene is required. While these vectors are versatile and are used widely in the research setting, large-scale production for human use poses various challenges to insure quality and high titer. Our vector production facility has produced and certified over 20 vectors for clinical use and continues to be challenged to adapt the ever-changing vector technology to a method of production that complies with Good Manufacturing Practice (GMP). We describe two manufacturing methods for producing material for Phase I/II clinical trials and suggest ways for investigators to adapt these methods for multiple applications.
Cornetta
Kenneth
K
Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
Reeves
Lilith
L
Cross
Scott
S
D000818:Animals; D002460:Cell Line; D005822:Genetic Vectors / Q000096:biosynthesis* / Q000235:genetics; D006801:Humans; D051379:Mice; D008967:Molecular Biology / Q000379:methods*; D012190:Retroviridae / Q000235:genetics* / Q000502:physiology; D014162:Transfection; D019065:Virus Assembly