Grudzinska-Goebel Joanna, Benstein Karin, Bloem Karien, Cowan Kyra J, Gorovits Boris, Jadhav Maria, Janssen Melody, Jawa Vibha, Kiessling Andrea, Kramer Daniel, Kromminga Arno, van der Linden Marcel, Liu Susana, Lotz Gregor P, Luo Linlin, Malisauskas Mantas, Marban-Doran Céline, Mytych Daniel T, Oquendo Cifuentes Elisa, Pippig Susanne, Ribes Sandra, Rouwette Myrthe, Shao Weiping, Tourdot Sophie, Weldingh Karin Nana, Snoeck Veerle
Preclinical Development, Pharmaceuticals R&D, Bayer AG, Berlin, Germany.
Translational Medicine Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
Front Immunol. 2025 May 22;16:1581153. doi: 10.3389/fimmu.2025.1581153. eCollection 2025.
Bringing safe and effective drugs to patients is of utmost importance for the pharmaceutical industry, with immunogenicity (IG) being a critical factor that influences both aspects. Biotherapeutics can elicit unwanted immune responses, potentially leading to (severe) safety implications, reduced patient benefits, and may result in termination of development. Therefore, understanding IG risks throughout drug development is essential for both drug developers and health agencies (HAs). The Immunogenicity Risk Assessment (IRA) facilitates the identification of IG risk factors and allows the establishment of effective mitigation and monitoring strategies. In this publication, the European Immunogenicity Platform (EIP) presents a comprehensive IRA framework aligned across pharmaceutical industry, emphasizing its significance in product development - from early de-risking to bioanalytical monitoring and mitigation measures during clinical trials. The EIP also provides an updated list of IG risks, offers distinct recommendations for assigning overall IG risk levels prior to the start of clinical development and highlights business considerations within this assessment.
将安全有效的药物带给患者对制药行业至关重要，免疫原性（IG）是影响这两方面的关键因素。生物治疗药物可能引发不良免疫反应，这有可能导致（严重的）安全问题、降低患者受益，并可能导致研发终止。因此，在整个药物研发过程中了解IG风险对药物研发人员和卫生机构（HA）都至关重要。免疫原性风险评估（IRA）有助于识别IG风险因素，并能制定有效的缓解和监测策略。在本出版物中，欧洲免疫原性平台（EIP）提出了一个贯穿制药行业的全面IRA框架，强调其在产品研发中的重要性——从早期风险降低到临床试验期间的生物分析监测和缓解措施。EIP还提供了一份IG风险的更新列表，为在临床开发开始前确定总体IG风险水平提供了明确建议，并突出了该评估中的商业考量。
