期刊
CURRENT PHARMACEUTICAL DESIGN
卷 19, 期 31, 页码 5471-5477出版社
BENTHAM SCIENCE PUBL LTD
DOI: 10.2174/1381612811319310002
关键词
Molecular farming; platform technology; innovation; disruptive technology; biopharmaceutical; GMP
资金
- EU projects Pharma-Planta [LSHB-CT-2003-503565, 227420]
- COST Action Molecular Farming [FA0804]
- ERC [269110]
- European Research Council (ERC) [269110] Funding Source: European Research Council (ERC)
Many different plant-based systems have been used to produce recombinant pharmaceutical proteins but only a small number have made the leap from an experimental platform to a viable commercial process. This reflects a combination of factors, principally the technical issues that must be addressed to achieve competitive performance, the economic principles that need to be satisfied to ensure manufacturing processes are financially viable and sustainable, and the regulatory demands that must be met to ensure that pharmaceuticals manufactured in plants are safe, efficacious and meet the quality standards demanded by the regulators. With the recent approval of the first plant-derived recombinant pharmaceutical protein designated for human use, we are now entering a new era in which plants not only meet all the demands of a commercial pharmaceutical manufacturing process but also provide unique benefits that allow the displacement of established platform technologies in niche markets. In this article, we consider the commercial aspects of molecular farming, specifically those required to make plants more competitive and attractive to industry.
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