Analytical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co KG, Birkendorfer Straße 65, 88397 Biberach an der Riß, Germany.
Analytical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co KG, Birkendorfer Straße 65, 88397 Biberach an der Riß, Germany.
J Pharm Biomed Anal. 2023 Sep 20;234:115584. doi: 10.1016/j.jpba.2023.115584. Epub 2023 Jul 16.
For biotherapeutic analytics, robust and reliable potency assays are required. Design of experiment (DoE) approaches are used to investigate the impact of multiple assay parameters. Currently, specific assay features (e.g., half effective concentration) are modelled independently from each other. A joint interpretation of several assay features is thus difficult. In our functional DoE approach, we use the functional relationship of the assay features to describe the sigmoidal dose-response curve. With the composed functional form, the direct impact of assay parameters on the dose-response curve shape was modelled. Moreover, a multivariate desirability was defined and used for assay optimization. We believe that functional modelling contributes to understanding the joint influence of assay parameters and helps to design robust biotherapeutic analytics.
对于生物治疗分析，需要强大且可靠的效价测定法。实验设计（DoE）方法用于研究多个测定参数的影响。目前，特定测定特征（例如，半有效浓度）彼此独立建模。因此，很难对几个测定特征进行联合解释。在我们的功能 DoE 方法中，我们使用测定特征的功能关系来描述 S 形剂量反应曲线。使用组合的功能形式，对测定参数对剂量反应曲线形状的直接影响进行了建模。此外，还定义了一个多元适用性，并将其用于测定优化。我们相信功能建模有助于理解测定参数的联合影响，并有助于设计稳健的生物治疗分析。
