Commercial Aspects of Pharmaceutical Protein Production in Plants
Commercial Aspects of Pharmaceutical Protein Production in Plants
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DOI：
10.2174/1381612811319310002
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发表时间：
2013-09-01
影响因子：
3.1
通讯作者：
Twyman, Richard M.
中科院分区：
文献类型：
--
作者：
Fischer, Rainer;Schillberg, Stefan;Twyman, Richard M.
许多不同的基于植物的系统已被用于生产重组药物蛋白，但只有少数已经从实验平台飞跃到可行的商业过程。这反映了多个因素的组合，主要是为实现竞争业绩而必须解决的技术问题，为确保生产工艺在财务上可行和可持续而必须满足的经济原则，以及为确保工厂生产的药品安全、有效并符合监管机构要求的质量标准而必须满足的监管要求。随着第一种植物源重组药物蛋白最近获得批准，我们现在正在进入一个新时代，在这个新时代，植物不仅满足商业制药工艺的所有需求，而且还提供独特的优势，允许在利基市场取代现有的平台技术。在这篇文章中，我们考虑了分子农业的商业方面，特别是那些需要使植物更具竞争力和吸引力的行业。
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.