PURPOSE: Stable vaccines with long shelf lives and reduced dependency on the cold chain are ideal for stockpiling and rapid deployment during public emergencies, including pandemics. Spray drying is a low-cost process that has potential to produce vaccines stable at a wide range of temperatures. Our aim was to develop a stable formulation of a recombinant H1N1 influenza hemagglutinin vaccine candidate and take it to pilot-scale spray-drying production. METHODS: Eight formulations containing different excipients were produced and assayed for antigen stability, powder characteristics, and immunogenicity after storage at a range of temperatures, resulting in the identification of four promising candidates. A pilot-scale spray-drying process was then developed for further testing of one formulation. RESULTS: The pilot-scale process was used to reproducibly manufacture three batches of the selected formulation with yields >90%. All batches had stable physical properties and in vitro potency for 6 months at temperatures from -20°C to +50°C. Formulations stored for 3 months elicited immunogenic responses in mice equivalent to a frozen lot of bulk vaccine used as a stability control. CONCLUSIONS: This study demonstrates the feasibility of stabilizing subunit vaccines using a spray-drying process and the suitability of the process for manufacturing a candidate product.
PURPOSE: Stable vaccines with long shelf lives and reduced dependency on the cold chain are ideal for stockpiling and rapid deployment during public emergencies, including pandemics. Spray drying is a low-cost process that has potential to produce vaccines stable at a wide range of temperatures. Our aim was to develop a stable formulation of a recombinant H1N1 influenza hemagglutinin vaccine candidate and take it to pilot-scale spray-drying production. METHODS: Eight formulations containing different excipients were produced and assayed for antigen stability, powder characteristics, and immunogenicity after storage at a range of temperatures, resulting in the identification of four promising candidates. A pilot-scale spray-drying process was then developed for further testing of one formulation. RESULTS: The pilot-scale process was used to reproducibly manufacture three batches of the selected formulation with yields >90%. All batches had stable physical properties and in vitro potency for 6 months at temperatures from -20°C to +50°C. Formulations stored for 3 months elicited immunogenic responses in mice equivalent to a frozen lot of bulk vaccine used as a stability control. CONCLUSIONS: This study demonstrates the feasibility of stabilizing subunit vaccines using a spray-drying process and the suitability of the process for manufacturing a candidate product.
Authors: Yoko Shoji; Jessica A Chichester; Hong Bi; Konstantin Musiychuk; Patricia de la Rosa; Lauren Goldschmidt; April Horsey; Natalia Ugulava; Gene A Palmer; Vadim Mett; Vidadi Yusibov Journal: Vaccine Date: 2008-04-09 Impact factor: 3.641
Authors: Lisa D Schlehuber; Iain J McFadyen; Yu Shu; James Carignan; W Paul Duprex; William R Forsyth; Jason H Ho; Christine M Kitsos; George Y Lee; Douglas A Levinson; Sarah C Lucier; Christopher B Moore; Niem T Nguyen; Josephine Ramos; B André Weinstock; Junhong Zhang; Julie A Monagle; Colin R Gardner; Juan C Alvarez Journal: Vaccine Date: 2011-05-25 Impact factor: 3.641
Authors: Mellissa Gomez; Michelle Archer; David Barona; Hui Wang; Mani Ordoubadi; Shabab Bin Karim; Nicholas B Carrigy; Zheng Wang; Joseph McCollum; Chris Press; Alana Gerhardt; Christopher B Fox; Ryan M Kramer; Reinhard Vehring Journal: Eur J Pharm Biopharm Date: 2021-03-19 Impact factor: 5.589