Safety issues of animal products used in serum-free media.

O W Merten
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Abstract

The development of media free of serum and animal or human protein is of utmost importance for increasing the safety of biologicals produced for therapy and vaccination. The main drawback associated with the use of serum or animal-derived substances for animal cell technology is the potential introduction of contaminants (adventitious agents) into the process and thus potentially into the final product. This fact led to an increased effort to replace serum-containing with serum-free media. In most cases, these media are supplemented with purified proteins, peptones, or hydrolysates, mainly of animal or human origin. Although such serum-free media are more defined than serum-containing media, the risk of the introduction of viruses by using animal-derived substances is still present, signifying that only a complete replacement of animal-derived substances by non-animal-derived products leads to a relatively safe serum-free medium. The potential replacement of these animal/human-derived substances by those of non-animal origin (e.g. plant origin) will be discussed. In several examples, the potential of serum-free media free of any animal-derived component in supporting cell growth and production of biologicals will be presented. In this context, the risk of using non-animal-derived substances in serum-free media for animal cell technology will be discussed with respect to classically used cell culture media.

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无血清培养基中使用的动物产品的安全问题。
开发不含血清和动物或人类蛋白质的培养基对于提高用于治疗和疫苗接种的生物制剂的安全性至关重要。在动物细胞技术中使用血清或动物源性物质的主要缺点是可能将污染物(不确定因素)引入该过程,从而可能进入最终产品。这一事实促使人们更加努力地用无血清培养基代替含血清培养基。在大多数情况下,这些培养基中补充了纯化的蛋白质、蛋白胨或水解物,主要来自动物或人类。虽然这种无血清培养基比含血清培养基更明确,但使用动物源性物质引入病毒的风险仍然存在,这表明只有用非动物源性产品完全取代动物源性物质,才能产生相对安全的无血清培养基。将讨论非动物来源物质(例如植物来源)替代这些动物/人类来源物质的可能性。在几个例子中,将介绍无血清培养基在支持细胞生长和生物制品生产方面的潜力,该培养基不含任何动物源性成分。在这种情况下,在无血清培养基中使用非动物源性物质用于动物细胞技术的风险将与传统使用的细胞培养基进行讨论。
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Virus removal by filtration. Gamma irradiation of bovine sera. Efficient inactivation of viruses and mycoplasma in animal sera using UVC irradiation. A universal virus inactivant for decontaminating blood and biopharmaceutical products. Serum and serum substitutes: virus safety by inactivation or removal.
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