title: Improved virus purification processes for vaccines and gene therapy.
abstract: The downstream processing of virus particles for vaccination or gene therapy is becoming a critical bottleneck as upstream titers keep improving. Moreover, the growing pressure to develop cost-efficient processes has brought forward new downstream trains. This review aims at analyzing the state-of-the-art in viral downstream purification processes, encompassing the classical unit operations and their recent developments. Emphasis is given to novel strategies for process intensification, such as continuous or semi-continuous systems based on multicolumn technology, opening up process efficiency. Process understanding in the light of the pharmaceutical quality by design (QbD) initiative is also discussed. Finally, an outlook of the upcoming breakthrough technologies is presented.
authors: Instituto de Biologia Experimental e Tecnológica, Apartado 12, 2781-901, Oeiras, Portugal; Instituto de Tecnologia Química e Biológica, Universidade Nova de Lisboa, 2780-157, Oeiras, Portugal.
authors: Piergiuseppe
authors: P
authors: Nestola
authors: Cristina
authors: C
authors: Peixoto
authors: Ricardo R J S
authors: RR
authors: Silva
authors: Paula M
authors: PM
authors: Alves
authors: José P B
authors: JP
authors: Mota
authors: Manuel J T
authors: MJ
authors: Carrondo
mesh_terms: D000818:Animals; D001709:Biotechnology / Q000379:methods*; D002499:Centrifugation, Density Gradient / Q000379:methods; D002845:Chromatography / Q000379:methods; D015316:Genetic Therapy / Q000379:methods; D006801:Humans; D013678:Technology, Pharmaceutical / Q000379:methods; D014462:Ultrafiltration / Q000379:methods; D014612:Vaccines / Q000302:isolation & purification*; D014771:Virion / Q000302:isolation & purification; D014780:Viruses / Q000302:isolation & purification*
chemical_list: D014612:Vaccines
keywords: continuous purification; downstream bioprocessing; gene therapy; process intensification; vaccines