title: Lyophilization of an Adjuvanted Mycobacterium tuberculosis Vaccine in a Single-Chamber Pharmaceutical Cartridge.
abstract: Although substantial effort has been made in the development of next-generation recombinant vaccine systems, maintenance of a cold chain is still typically required and remains a critical challenge in effective vaccine distribution. The ability to engineer alternative containment systems that improve distribution and administration represents potentially significant enhancements to vaccination strategies. In this work, we evaluate the ability to successfully lyophilize a previously demonstrated thermostable tuberculosis vaccine formulation (ID93 + GLA-SE) in a cartridge format compared to a traditional vial container format. Due to differences in the shape of the container formats, a novel apparatus was developed to facilitate lyophilization in a cartridge. Following lyophilization, the lyophilizate was assessed visually, by determining residual moisture content, and by collecting melting profiles. Reconstituted formulations were assayed for particle size, protein presence, and GLA content. Based on assessment of the lyophilizate, the multicomponent vaccine was successfully lyophilized in both formats. Also, the physicochemical properties of the major components in the formulation, including antigen and adjuvant, were retained after lyophilization in either format. Ultimately, this study demonstrates that complex formulations can be lyophilized in alternative container formats to the standard pharmaceutical glass vial, potentially helping to increase the distribution of vaccines.
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA.
authors.forename: Lucien
authors.initials: L
authors.lastname: Barnes V
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA.
authors.forename: Dawn M
authors.initials: DM
authors.lastname: Fedor
authors.affiliation: Duoject Medical Systems Inc., 50 Chemin de Gaspé, ComplexB-5, Bromont, Quebec, J2L2N8, Canada.
authors.forename: Simon
authors.initials: S
authors.lastname: Williams
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA.
authors.forename: Quinton M
authors.initials: QM
authors.lastname: Dowling
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA.
authors.forename: Michelle C
authors.initials: MC
authors.lastname: Archer
authors.affiliation: Duoject Medical Systems Inc., 50 Chemin de Gaspé, ComplexB-5, Bromont, Quebec, J2L2N8, Canada.
authors.forename: Sylvain
authors.initials: S
authors.lastname: Cloutier
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Parker
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA.
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Vedvick
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Fox
authors.affiliation: Infectious Disease Research Institute, 1616 Eastlake Ave. E., Suite 400, Seattle, Washington, 98102, USA. Ryan.Kramer@idri.org.
authors.forename: Ryan M
authors.initials: RM
authors.lastname: Kramer
mesh_terms: D000276:Adjuvants, Immunologic / Q000138:chemical synthesis*; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation* / Q000379:methods; D005612:Freeze Drying / Q000379:methods; D009169:Mycobacterium tuberculosis; D004364:Pharmaceutical Preparations; D032581:Tuberculosis Vaccines / Q000138:chemical synthesis*
chemical_list: D000276:Adjuvants, Immunologic; D004364:Pharmaceutical Preparations; D032581:Tuberculosis Vaccines
keywords: adjuvant; cartridge; lyophilization; vaccine