title: Developing novel lentiviral vectors into clinical products.
abstract: Gene therapy vectors based on murine retroviruses have now been in clinical trials for over 20 years. During that time, a variety of novel vector pseudotypes were developed in an effort to improve gene transfer. Lentiviral vectors are now in clinical trials and a similar evolution of vector technology is anticipated. These modifications present challenges for those producing large-scale clinical materials. This chapter discusses approaches to process development for novel lentiviral vectors, highlight considerations, and methods to be incorporated into the development schema.
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Leath
authors.forename: Kenneth
authors.initials: K
authors.lastname: Cornetta
mesh_terms: D018929:Cell Culture Techniques; D002852:Chromatography, Ion Exchange; D005818:Genetic Engineering / Q000379:methods; D015316:Genetic Therapy / Q000379:methods; D005822:Genetic Vectors; D057809:HEK293 Cells; D015497:HIV-1 / Q000235:genetics* / Q000302:isolation & purification / Q000502:physiology; D006801:Humans; D058889:Molecular Typing; D014162:Transfection / Q000379:methods; D014779:Virus Replication; D054299:env Gene Products, Human Immunodeficiency Virus / Q000235:genetics
chemical_list: D054299:env Gene Products, Human Immunodeficiency Virus