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profiling the Effects of Process Changes on Residual Host Cell Proteins in Biotherapeutics by Mass Spectrometry

机译：质谱分析生物制药中过程变化对残留宿主细胞蛋白的影响

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摘要

An advanced liquid chromatography/mass spectrometry (MS) platform was used to identify and quantify residual Escherichia coli host cell proteins (HCPs) in the drug substance (DS) of several peptibodies (Pbs). Significantly different HCP impurity profiles were observed among different biotherapeutic Pbs as well as one Pb purified via multiple processes. The results can be rationally interpreted in terms of differences among the purification processes, and demonstrate the power of this technique to sensitively monitor both the quantity and composition of residual HCPs in DS, where these may represent a safety risk to patients. The breadth of information obtained using MS is compared to traditional multi-product enzyme-linked immunosorbent assay (ELISA) values for total HCP in the same samples and shows that, in this case, the ELISA failed to detect multiple HCPs. The HCP composition of two upstream samples was also analyzed and used to demonstrate that HCPs that carry through purification processes to be detectable in DS are not always among those that are the most abundant upstream. Compared to ELISA, we demonstrate that MS can provide a more comprehensive, and accurate, characterization of DS HCPs, thereby facilitating process development as well as more rationally assessing potential safety risks posed by individual, identified HCPs.
机译：先进的液相色谱/质谱（MS）平台用于鉴定和定量几种肽体（Pb）的原料药（DS）中残留的大肠杆菌宿主细胞蛋白（HCP）。在不同的生物治疗性铅以及通过多种工艺纯化的一种铅中，观察到明显不同的HCP杂质分布。可以根据纯化过程之间的差异合理地解释结果，并证明该技术可以灵敏地监测DS中残留HCP的数量和组成，其中这可能对患者构成安全风险。将使用MS获得的信息广度与相同样品中HCP的传统多产品酶联免疫吸附测定（ELISA）值进行比较，结果表明，在这种情况下，ELISA无法检测到多个HCP。还分析了两个上游样品的HCP组成，并用于证明通过纯化过程可在DS中检测到的HCP并不总是在上游含量最高的样品中。与ELISA相比，我们证明MS可以提供​​DS HCP的更全面，准确的表征，从而促进工艺开发并更合理地评估由个别HCP带来的潜在安全风险。

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