PT  - JOURNAL ARTICLE
AU  - Christopher D. Mensch
AU  - Harrison B. Davis
AU  - Jeffrey T. Blue
TI  - Characterization of Propylene Glycol–Mitigated Freeze/Thaw Agglomeration of a Frozen Liquid nOMV Vaccine Formulation by Static Light Scattering and Micro-Flow Imaging
AID  - 10.5731/pdajpst.2015.01057
DP  - 2015 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 477--498
VI  - 69
IP  - 4
4099  - http://journal.pda.org/content/69/4/477.short
4100  - http://journal.pda.org/content/69/4/477.full
SO  - PDA J Pharm Sci Technol2015 Jul 01; 69
AB  - The purpose of this work was to investigate the susceptibility of an aluminum adjuvant and an aluminum-adjuvanted native outer membrane vesicle (nOMV) vaccine formulation to freeze/thaw–induced agglomeration using static light scattering and micro-flow Imaging analysis; and to evaluate the use of propylene glycol as a vaccine formulation excipient by which freeze/thaw–induced agglomeration of a nOMV vaccine formulation could be mitigated. Our results indicate that including 7% v/v propylene glycol in an nOMV containing aluminum adjuvanted vaccine formulation, mitigates freeze/thaw–induced agglomeration.LAY ABSTRACT: We evaluated the effect of freeze-thawing on an aluminum adjuvant and an aluminum adjuvanted native outer membrane vesicle (nOMV) vaccine formulation. Specifically, we characterized the freeze/thaw–induced agglomeration through the use of static light scattering, micro-flow imaging, and cryo-electron microscopy analysis. Further, we evaluated the use of 0–9% v/v propylene glycol as an excipient which could be included in the formulation for the purpose of mitigating the agglomeration induced by freeze/thaw. The results indicate that using 7% v/v propylene glycol as a formulation excipient is effective at mitigating agglomeration of the nOMV vaccine formulation, otherwise induced by freeze-thawing.