This paper analyzes the use of animal-component free chromatographic materials for the efficient purification of the human fibroblast growth factor 2 (hFGF-2). hFGF-2 is produced in Escherichia coli and purified via three different chromatography steps, which include a strong cation exchange chromatography as a capture step, followed by heparin affinity chromatography and an anion exchange chromatography as a polishing step. The affinity chromatography step is based on the animal-derived material heparin. Chemically produced ligands provide a viable alternative to animal-derived components in production processes, since they are characterized by a defined structure which leads to reproducible results and a broad range of applications. The alternative ligands can be assigned to adsorber of the mixed-mode chromatography (MMC) and pseudo-affinity chromatography.

Eight different animal-component free materials used as adsorbers in MMC or pseudo-affinity chromatography were tested as a substitute for heparin. The MMCs were cation exchangers characterized with further functional residues. The ligands of the pseudo-affinity chromatography were heparin-like ligands which are based on heparin's molecular structure. The alternative methods were tested as a capture step and in combination with another chromatographic step in the purification procedure of hFGF-2. In each downstream step purity, recovery and yield were analysed and compared to the conventional downstream process.

Two types of MMC – the column Foresight^TM Nuvia^TM cPrime^TM from Bio-Rad Laboratories and the column HiTrap^TM Capto^TM MMC from GE Healthcare Life Sciences - can be regarded as effective animal-component free alternatives to the heparin - based adsorber.

本文分析了无动物成分的色谱材料在有效纯化人成纤维细胞生长因子2（hFGF-2）中的用途。hFGF-2在大肠杆菌中产生并通过三个不同的色谱步骤进行纯化，包括强阳离子交换色谱作为捕获步骤，然后进行肝素亲和色谱和阴离子交换色谱作为抛光步骤。亲和层析步骤基于动物来源的物质肝素。化学生产的配体在生产过程中提供了动物衍生成分的可行替代方案，因为它们的特征在于确定的结构，可导致可再现的结果和广泛的应用范围。可以将替代配体分配给混合模式色谱（MMC）和拟亲和色谱的吸附器。

测试了八种不同的无动物成分的材料在MMC或伪亲和色谱中用作吸附剂，以替代肝素。MMC是具有其他功能残基的阳离子交换剂。拟亲和色谱的配体是肝素样配体，其基于肝素的分子结构。在hFGF-2的纯化程序中，将替代方法作为捕获步骤并与另一个色谱步骤结合进行了测试。在每个下游步骤中，分析纯度，回收率和产率并将其与常规下游工艺进行比较。

两种类型的MMC –来自Bio-Rad Laboratories的Foresight ^TM Nuvia ^TM cPrime ^TM色谱柱和来自GE Healthcare Life Sciences的HiTrap ^TM Capto ^TM MMC色谱柱-被认为是基于肝素的吸附剂的无动物成分的有效替代品。