Biological Technologies, Department of Analytical Development and Quality Control, Genentech-A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080, USA.
Cell Therapy Analytical Development, Department of Cell Therapy Engineering and Development, Genentech-A Member of the Roche Group, South San Francisco, CA 94080, USA.
Int J Mol Sci. 2021 May 19;22(10):5350. doi: 10.3390/ijms22105350.
Antibody therapeutics are expanding with promising clinical outcomes, and diverse formats of antibodies are further developed and available for patients of the most challenging disease areas. Bispecific antibodies (BsAbs) have several significant advantages over monospecific antibodies by engaging two antigen targets. Due to the complicated mechanism of action, diverse structural variations, and dual-target binding, developing bioassays and other types of assays to characterize BsAbs is challenging. Developing bioassays for BsAbs requires a good understanding of the mechanism of action of the molecule, principles and applications of different bioanalytical methods, and phase-appropriate considerations per regulatory guidelines. Here, we review recent advances and case studies to provide strategies and insights for bioassay development for different types of bispecific molecules.
抗体疗法的临床疗效令人鼓舞，不断发展的抗体多样化形式为最具挑战性疾病领域的患者提供了更多选择。双特异性抗体 (BsAb) 通过结合两个抗原靶点，具有优于单克隆抗体的几个显著优势。由于作用机制复杂、结构变异多样和双靶点结合，开发用于表征 BsAb 的生物分析方法和其他类型的检测方法具有挑战性。开发 BsAb 的生物分析方法需要深入了解分子的作用机制、不同生物分析方法的原理和应用，以及根据监管指南进行适当的阶段考虑。在这里，我们回顾了最近的进展和案例研究，为不同类型的双特异性分子的生物分析方法的开发提供了策略和见解。
