Therapeutic proteins and emerging gene and cell-based therapies are attractive therapeutic tools for addressing unmet medical needs or when earlier conventional treatment approaches failed. However, the development of an immune response directed against therapeutic agents is a significant concern as it occurs in a substantial number of cases across products and indications. The specific anti-drug antibodies that develop can lead to safety adverse events as well as inhibition of drug activity or accelerated clearance, both phenomena resulting in loss of treatment efficacy. The European Immunogenicity Platform (EIP) is a meeting place for experts and newcomers to the immunogenicity field, designed to stimulate discussion amongst scientists across industry and academia, encourage interactions with regulatory agencies and share knowledge and the state-of-the-art of immunogenicity sciences with the broader scientific community. Here we report on the main topics covered during the EIP 10th Open Symposium on Immunogenicity of Biopharmaceuticals held in Lisbon, 26-27 February 2019, and the 1-d training course on practical and regulatory aspects of immunogenicity held ahead of the conference. These main topics included immunogenicity testing, clinical relevance of immunogenicity, immunogenicity prediction, regulatory aspects, tolerance induction as a mean to mitigate immunogenicity and immunogenicity in the context of gene therapy.

中文翻译：

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第十届欧洲免疫原性平台生物药物免疫原性公开研讨会。

治疗性蛋白质以及新兴的基于基因和细胞的疗法是解决未满足的医疗需求或当较早的常规疗法失败时的有吸引力的治疗工具。然而，针对治疗剂的免疫应答的发展是一个重大问题，因为它在产品和适应症的许多情况下都会发生。产生的特异性抗药物抗体可导致安全性不良事件以及抑制药物活性或加速清除，这两种现象均导致治疗效果下降。欧洲免疫原性平台（EIP）是免疫原性领域的专家和新来者的聚会场所，旨在激发整个行业和学术界的科学家之间的讨论，鼓励与监管机构的互动，并与更广泛的科学界共享知识和最新的免疫原性科学。在此，我们将报告2019年2月26日至27日在里斯本举行的EIP第10届生物药物免疫原性公开研讨会以及会议召开前举行的有关免疫原性的实用和法规方面的一维培训课程的主要主题。这些主要主题包括免疫原性测试，免疫原性的临床相关性，免疫原性预测，调节方面，耐受性诱导，以减轻基因治疗中的免疫原性和免疫原性。在此，我们将报告2019年2月26日至27日在里斯本举行的EIP第10届生物药物免疫原性公开研讨会以及会议召开前举行的有关免疫原性的实用和法规方面的一维培训课程的主要主题。这些主要主题包括免疫原性测试，免疫原性的临床相关性，免疫原性预测，调节方面，耐受性诱导，以减轻基因治疗中的免疫原性和免疫原性。在此，我们将报告2019年2月26日至27日在里斯本举行的EIP第10届生物药物免疫原性公开研讨会以及会议召开前举行的有关免疫原性的实用和法规方面的一维培训课程的主要主题。这些主要主题包括免疫原性测试，免疫原性的临床相关性，免疫原性预测，调节方面，耐受性诱导，以减轻基因治疗中的免疫原性和免疫原性。