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首页> 外文期刊>Biotechnology Advances: An International Review Journal >GMP issues for recombinant plant-derived pharmaceutical proteins. (Special Issue: Foreign protein production using plant cells: opportunities and challenges.)
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GMP issues for recombinant plant-derived pharmaceutical proteins. (Special Issue: Foreign protein production using plant cells: opportunities and challenges.)

机译：重组植物衍生药物蛋白的GMP问题。 （特刊：利用植物细胞生产外来蛋白质：机遇与挑战。）

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摘要

Recombinant proteins can be produced in a diverse array of plant-based systems, ranging from whole plants growing in the soil to plant suspension cells growing in a fully-defined synthetic medium in a bioreactor. When the recombinant proteins are intended for medical use (plant-derived pharmaceutical proteins, PDPs) they fall under the same regulatory guidelines for manufacturing that cover drugs from all other sources, and when such proteins enter clinical development this includes the requirement for production according to good manufacturing practice (GMP). In principle, the well-characterized GMP regulations that apply to pharmaceutical proteins produced in bacteria and mammalian cells are directly transferrable to plants. In practice, the cell-specific terminology and the requirement for a contained, sterile environment mean that only plant cells in a bioreactor fully meet the original GMP criteria. Significant changes are required to adapt these regulations for proteins produced in whole-plant systems and it is only recently that the first GMP-compliant production processes using plants have been delivered.
机译：重组蛋白可以在各种各样的基于植物的系统中生产，范围从土壤中生长的整个植物到生物反应器中完全定义的合成培养基中生长的植物悬浮细胞。当重组蛋白用于医疗用途（植物衍生的药物蛋白，PDP）时，它们将受相同的法规监管，涵盖所有其他来源的药物;当此类蛋白进入临床开发时，这包括根据以下要求进行生产的要求：良好生产规范（GMP）。原则上，适用于细菌和哺乳动物细胞中产生的药物蛋白的，公认的GMP法规可以直接转移到植物中。实际上，特定于细胞的术语和对封闭无菌环境的要求意味着只有生物反应器中的植物细胞才能完全满足原始GMP标准。为了使这些法规适用于整个植物系统中产生的蛋白质，需要进行重大更改，直到最近才交付了使用植物的第一个符合GMP的生产工艺。

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