tetano
Editor, Senior Moderator
Pharm Res. 2014 May 24. [Epub ahead of print]
Stabilization of HAC1 Influenza Vaccine by Spray Drying: Formulation Development and Process Scale-Up.
Zhu C1, Shoji Y, McCray S, Burke M, Hartman CE, Chichester JA, Breit J, Yusibov V, Chen D, Lal M.
Author information
Abstract
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.
PMID:
24858396
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24858396
Stabilization of HAC1 Influenza Vaccine by Spray Drying: Formulation Development and Process Scale-Up.
Zhu C1, Shoji Y, McCray S, Burke M, Hartman CE, Chichester JA, Breit J, Yusibov V, Chen D, Lal M.
Author information
Abstract
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.
PMID:
24858396
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24858396