为什么我们仍然在生物制药的生产中使用血清?

G Shah
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引用次数: 0

摘要

一般来说,真核细胞在体外生长需要血清。血清是一种由大量成分组成的复杂混合物,因此血清的加入为细胞培养引入了一个模糊的因素。然而,许多市售血清的质量都很统一。其中,胎牛血清是最常用的,能够支持多种真核细胞的生长。然而,随着不同细胞所需的必需生长因子和营养物质的鉴定,几种非常有效的无血清培养基已经被配制出来。这些无血清培养基的使用仅限于非常狭窄的细胞范围。监管限制通常使改变以血清为原料的现有生物制药生产工艺变得不切实际和不经济。
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Why do we still use serum in the production of biopharmaceuticals?

Eukaryotic cells, in general, require serum for growth in vitro. Serum is a complex mixture of a large number of constituents, so the addition of serum introduces an ambiguous factor into cell cultivation. However, many commercially available sera are of a high uniform quality. Of these, foetal bovine serum is the most frequently used and is capable of supporting the growth of a wide variety of eukaryotic cells. However, with the identification of essential growth factors and nutrients required by different cells, several very effective serum-free media have been formulated. The use of these serum-free media is limited to a very narrow range of cells. Regulatory constraints generally make it impractical and uneconomic to alter existing biopharmaceutical production processes in which serum is used as a raw material.

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