Good manufacturing practices production of a purification-free oral cholera vaccine expressed in transgenic rice plants
| Autor: | Masaharu Kuroda, Yoshiko Fukuyama, Yuji Suzuki, Shiho Kurokawa, Natsumi Takeyama, Yasuyuki Gomi, Yoshikazu Yuki, Tatsuhiko Azegami, Koji Kashima, Minoru Tamura, Mio Mejima, Hiroshi Kiyono, Takeshi Tanimoto, Satomi Minakawa |
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| Rok vydání: | 2015 |
| Předmět: |
0301 basic medicine
Diarrhea Cholera Toxin media_common.quotation_subject Cost-Benefit Analysis Blotting Western Administration Oral Plant Science Genetically modified crops Biology complex mixtures 03 medical and health sciences Mice Cholera Drug Stability Cultivation System Production (economics) Animals Humans Technology Pharmaceutical Quality (business) Vibrio cholerae Drug Packaging media_common business.industry food and beverages Reproducibility of Results Cholera Vaccines Oryza General Medicine Plants Genetically Modified Genetically modified rice Phase i study Biotechnology Product (business) 030104 developmental biology Immunization Powders Cholera vaccine business Agronomy and Crop Science |
| Zdroj: | Plant cell reports. 35(3) |
| ISSN: | 1432-203X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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