Wadhwa Meenu, Thorpe Robin
Biotherapeutics Group, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK. Meenu.Wadhwa@ nibsc.hpa.org.uk
Bioanalysis. 2010 Jun;2(6):1073-84. doi: 10.4155/bio.10.54.
All biological therapeutics have the potential to induce an immune response in recipients of these products. Elicitation of an immune response can result in variable clinical impact, ranging from benign to severe adverse effects, a diminution in clinical efficacy or, in some cases, hypersensitivity or allergic reactions. Consequently, assessment of unwanted immunogenicity is an important element of the data required for regulatory submission for product approval. However, issues relating to immunogenicity occur throughout the life-cycle of a biotherapeutic and need to be considered appropriately when introducing any product change(s). Evaluation of immunogenicity of a product requires a well-considered strategy and a panel of appropriately validated (or 'fit-for-purpose') assays for antibody detection and characterization in clinical samples. An overview of the bioanalytical methods that are currently being used for assessment of immunogenicity of biotherapeutics and the guidance available along with some of the challenges facing the industry are discussed in this review.
所有生物治疗药物都有可能在这些产品的接受者中引发免疫反应。免疫反应的引发可能导致不同的临床影响，从良性到严重的不良反应、临床疗效降低，或在某些情况下引发超敏反应或过敏反应。因此，对不必要的免疫原性进行评估是产品批准监管申报所需数据的重要组成部分。然而，与免疫原性相关的问题在生物治疗药物的整个生命周期中都会出现，在引入任何产品变更时都需要进行适当考虑。评估产品的免疫原性需要一个经过深思熟虑的策略以及一组经过适当验证（或“适用目的”）的用于临床样本中抗体检测和表征的分析方法。本文综述了目前用于评估生物治疗药物免疫原性的生物分析方法、可用的指导以及该行业面临的一些挑战。
