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.
journal_name
Plant Cell Repjournal_title
Plant cell reportsauthors
Kashima K,Yuki Y,Mejima M,Kurokawa S,Suzuki Y,Minakawa S,Takeyama N,Fukuyama Y,Azegami T,Tanimoto T,Kuroda M,Tamura M,Gomi Y,Kiyono Hdoi
10.1007/s00299-015-1911-9subject
Has Abstractpub_date
2016-03-01 00:00:00pages
667-79issue
3eissn
0721-7714issn
1432-203Xpii
10.1007/s00299-015-1911-9journal_volume
35pub_type
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journal_title:Plant cell reports
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