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Stability and pre-formulation development of a plant-produced anthrax vaccine candidate.
Jones, R Mark; Burke, Michael; Dubose, Devon; Chichester, Jessica A; Manceva, Slobodanka; Horsey, April; Streatfield, Stephen J; Breit, Jeff; Yusibov, Vidadi.
Afiliação
  • Jones RM; Fraunhofer USA Center for Molecular Biotechnology, 9 Innovation Way, Newark, DE 19711, USA. Electronic address: mark.jones@fhcmb.org.
  • Burke M; Capsugel, 64550 Research Road, Bend, OR 97701, USA.
  • Dubose D; Capsugel, 64550 Research Road, Bend, OR 97701, USA.
  • Chichester JA; Fraunhofer USA Center for Molecular Biotechnology, 9 Innovation Way, Newark, DE 19711, USA.
  • Manceva S; Fraunhofer USA Center for Molecular Biotechnology, 9 Innovation Way, Newark, DE 19711, USA.
  • Horsey A; Fraunhofer USA Center for Molecular Biotechnology, 9 Innovation Way, Newark, DE 19711, USA.
  • Streatfield SJ; Fraunhofer USA Center for Molecular Biotechnology, 9 Innovation Way, Newark, DE 19711, USA.
  • Breit J; Capsugel, 64550 Research Road, Bend, OR 97701, USA. Electronic address: jeff.breit@Capsugel.com.
  • Yusibov V; Fraunhofer USA Center for Molecular Biotechnology, 9 Innovation Way, Newark, DE 19711, USA.
Vaccine ; 35(41): 5463-5470, 2017 10 04.
Article em En | MEDLINE | ID: mdl-28117174
ABSTRACT
Second generation anthrax vaccines focus on the use of recombinant protective antigen (rPA) to elicit a strong, toxin neutralizing antibody responses in immunized subjects. The main difference between the rPA vaccines compared to the current licensed vaccine, anthrax vaccine absorbed (AVA), is the rPA vaccines are highly purified preparations of only rPA. These second generation rPA vaccines strive to elicit strong immune responses with substantially fewer doses than AVA while provoking less side effects. Many of the rPA candidates have shown to be effective in pre-clinical studies, but most of the second generation molecules have stability issues which reduce their efficacy over time. These stability issues are evident even under refrigerated conditions and thus emphasis has been directed to stabilizing the rPA molecule and determining an optimized final formulation. Stabilization of vaccines for long-term storage is a major challenge in the product development life cycle. The effort required to identify suitable formulations can be slow and expensive. The ideal storage for stockpiled vaccines would allow the candidate to withstand years of storage at ambient temperatures. The Fraunhofer Center for Molecular Biotechnology is developing a plant-produced rPA vaccine candidate that shows instability when stored under refrigerated conditions in a solution, as is typical for rPA vaccines. Increased stability of our plant-produced rPA vaccine candidate was achieved in a spray dried powder formulation that could eliminate the need for conventional cold chain allowing greater confidence to stockpile vaccine for civilian and military biodefense.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Plantas / Vacinas Sintéticas / Vacinas contra Antraz Limite: Animals Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Plantas / Vacinas Sintéticas / Vacinas contra Antraz Limite: Animals Idioma: En Ano de publicação: 2017 Tipo de documento: Article