Regeneron Pharmaceuticals, Bioanalytical Sciences, 777 Old Saw Mill River Rd, Tarrytown, NY 10591, USA.
AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Bioanalysis. 2020 Sep;12(18):1325-1336. doi: 10.4155/bio-2020-0174. Epub 2020 Sep 18.
Immunogenicity is recognized as a possible clinical risk due to the development of anti drug antibodies (ADAs) that can adversely impact drug safety and efficacy. Although robust assays are currently used to assess the ADA, there is a debate on how best to generate the most appropriate immunogenicity data. There are several factors that can trigger ADA formation including the immunity status of the target population and the severity of the disease indication. Immunogenicity testing has defaulted to the most conservative approach regardless of the inherent risk of the molecule or the patient population. For low-risk biotherapeutics such as human monoclonal antibodies, ADA data that provide clinically relevant information should be prioritized when establishing immunogenicity monitoring plans.
免疫原性被认为是一种可能的临床风险，因为会产生抗药物抗体 (ADA)，这可能会对药物安全性和疗效产生不利影响。虽然目前有强大的检测方法用于评估 ADA，但对于如何生成最合适的免疫原性数据存在争议。有几个因素会触发 ADA 的形成，包括目标人群的免疫状态和疾病指征的严重程度。免疫原性检测默认采用最保守的方法，而不管分子或患者人群的固有风险如何。对于低风险的生物疗法，如人源单克隆抗体，在制定免疫监测计划时，应优先考虑提供具有临床相关性信息的 ADA 数据。
