Good manufacturing practices production of a purification-free oral cholera vaccine expressed in transgenic rice plants.
Plant Cell Rep
; 35(3): 667-79, 2016 Mar.
Article
em En
| MEDLINE
| ID: mdl-26661780
ABSTRACT
KEY MESSAGE The first Good Manufacturing Practices production of a purification-free rice-based oral cholera vaccine (MucoRice-CTB) from transgenic plants in a closed cultivation system yielded a product meeting regulatory requirements. Despite our knowledge of their advantages, plant-based vaccines remain unavailable for human use in both developing and industrialized countries. A leading, practical obstacle to their widespread use is producing plant-based vaccines that meet governmental regulatory requirements. Here, we report the first production according to current Good Manufacturing Practices of a rice-based vaccine, the cholera vaccine MucoRice-CTB, at an academic institution. To this end, we established specifications and methods for the master seed bank (MSB) of MucoRice-CTB, which was previously generated as a selection-marker-free line, evaluated its propagation, and given that the stored seeds must be renewed periodically. The production of MucoRice-CTB incorporated a closed hydroponic system for cultivating the transgenic plants, to minimize variations in expression and quality during vaccine manufacture. This type of molecular farming factory can be operated year-round, generating three harvests annually, and is cost- and production-effective. Rice was polished to a ratio of 95 % and then powdered to produce the MucoRice-CTB drug substance, and the identity, potency, and safety of the MucoRice-CTB product met pre-established release requirements. The formulation of MucoRice-CTB made by fine-powdering of drug substance and packaged in an aluminum pouch is being evaluated in a physician-initiated phase I study.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Oryza
/
Vacinas contra Cólera
/
Tecnologia Farmacêutica
/
Plantas Geneticamente Modificadas
Limite:
Animals
/
Humans
Idioma:
En
Revista:
Plant Cell Rep
Assunto da revista:
BOTANICA
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Japão