Journal
PLANT CELL REPORTS
Volume 35, Issue 3, Pages 667-679Publisher
SPRINGER
DOI: 10.1007/s00299-015-1911-9
Keywords
GMP production; Molecular farming; MucoRice; Oral vaccine; Seed bank
Categories
Funding
- Ministry of Economy, Trade, and Industry
- New Energy and Industrial Technology Development Organization (NEDO)
- Ministry of Education, Culture, Sports, Science, and Technology of Japan
- Ministry of Health, Labor and Welfare of Japan
- Translational Research Network Program, Seed C
- Adaptable and Seamless Technology Transfer Program through Target-driven RD (A-step)
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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 preestablished 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.
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