title: Formulation and stabilization of recombinant protein based virus-like particle vaccines.
abstract: Vaccine formulation development has traditionally focused on improving antigen storage stability and compatibility with conventional adjuvants. More recently, it has also provided an opportunity to modify the interaction and presentation of an antigen/adjuvant to the immune system to better stimulate the desired immune responses for maximal efficacy. In the last decade, there has been a paradigm shift in vaccine antigen and formulation design involving an improved physical understanding of antigens and a better understanding of the immune system. In addition, the discovery of novel adjuvants and delivery systems promises to further improve the design of new, more effective vaccines. Here we describe some of the fundamental aspects of formulation design applicable to virus-like-particle based vaccine antigens (VLPs). Case studies are presented for commercially approved VLP vaccines as well as some investigational VLP vaccine candidates. An emphasis is placed on the biophysical analysis of vaccines to facilitate formulation and stabilization of these particulate antigens.
authors.affiliation: Macromolecule and Vaccine Stabilization Center, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA.
authors.forename: Nishant K
authors.initials: NK
authors.lastname: Jain
authors.affiliation: Macromolecule and Vaccine Stabilization Center, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA.
authors.forename: Neha
authors.initials: N
authors.lastname: Sahni
authors.affiliation: Macromolecule and Vaccine Stabilization Center, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA.
authors.forename: Ozan S
authors.initials: OS
authors.lastname: Kumru
authors.affiliation: Macromolecule and Vaccine Stabilization Center, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA.
authors.forename: Sangeeta B
authors.initials: SB
authors.lastname: Joshi
authors.affiliation: Macromolecule and Vaccine Stabilization Center, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Volkin
authors.affiliation: Macromolecule and Vaccine Stabilization Center, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA. Electronic address: middaugh@ku.edu.
authors.forename: C
authors.initials: C
authors.lastname: Russell Middaugh
mesh_terms: D000276:Adjuvants, Immunologic / Q000737:chemistry*; D000818:Animals; D000941:Antigens / Q000276:immunology; D002626:Chemistry, Pharmaceutical / Q000379:methods; D016503:Drug Delivery Systems; D015195:Drug Design; D006801:Humans; D055550:Protein Stability; D011994:Recombinant Proteins / Q000737:chemistry / Q000276:immunology; D058425:Vaccines, Virus-Like Particle / Q000737:chemistry* / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000941:Antigens; D011994:Recombinant Proteins; D058425:Vaccines, Virus-Like Particle
keywords: Formulation; Protein; Stability; Vaccine; Virus like particles