Bioanalysis, Immunogenicity & Biomarkers, In-Vitro/In-Vivo Translation, R&D Research, GlaxoSmithKline Pharmaceuticals, 1250 South Collegeville Rd, Collegeville, PA 19426, USA.
Bioanalysis. 2021 May;13(10):817-827. doi: 10.4155/bio-2020-0253. Epub 2021 Mar 26.
High-quality critical reagents are essential to the successful support of biotherapeutic drug development regardless of the analytical platform used for support. The lack of such a reagent, early in the development lifecycle of a biotherapeutic can have detrimental impact on resource and translation of data across development phases. Here, a pharmacokinetic assay case study is shared that illustrates what can occur when there is a lack of a reproducible and sustainable critical reagent early in the development lifecycle of a biotherapeutic. Various assay formats and critical reagents, as well as reagents generation programs, were initiated to find a reagent and assay format which was fit for purpose. Identification of appropriate critical reagents early in the development lifecycle of a biotherapeutic as advantageous.
高质量的关键试剂对于支持生物治疗药物的开发至关重要，无论用于支持的分析平台如何。在生物治疗药物开发的早期，如果缺乏这样的试剂，会对资源和开发阶段的数据转化产生不利影响。在这里，分享了一个药代动力学分析方法的案例研究，说明了在生物治疗药物开发的早期缺乏可重复和可持续的关键试剂时会发生什么情况。为了找到适合目的的试剂和分析方法，启动了各种分析方法和关键试剂，以及试剂生成方案。在生物治疗药物开发的早期识别合适的关键试剂是有利的。
