Shankar Gopi, Shores Elizabeth, Wagner Carrie, Mire-Sluis Anthony
Clinical Pharmacology & Experimental Medicine, Centocor Research & Development, Inc., 145 King of Prussia Road, Radnor, PA 19087, USA.
Trends Biotechnol. 2006 Jun;24(6):274-80. doi: 10.1016/j.tibtech.2006.04.001. Epub 2006 May 2.
Immune responses against non-vaccine biologics can affect their efficacy and safety, resulting in adverse events that could include administration reactions, hypersensitivity, deficiency syndromes and lack of a clinical response in treated patients. With the relatively recent development of numerous biologics, immunogenicity testing has become a key component in the demonstration of clinical safety and efficacy; in fact, it is highly unlikely that regulatory approval would be granted for a biologic without an assessment of its immunogenicity. However, recommendations from regulatory agencies regarding the requirements for when and how to carry out immunogenicity testing are dispersed among numerous guidance documents. To enable the evaluation of the effects of immunogenicity on safety and efficacy, the authors have consolidated recommendations from the regulatory guidelines, and present current approaches and future directions for the assessment of immunogenicity.
针对非疫苗生物制品的免疫反应会影响其疗效和安全性，导致不良事件，这些不良事件可能包括给药反应、超敏反应、缺乏症综合征以及治疗患者无临床反应。随着众多生物制品在近期的相对发展，免疫原性检测已成为证明临床安全性和疗效的关键组成部分；事实上，若未对生物制品的免疫原性进行评估，极不可能获得监管部门的批准。然而，监管机构关于何时以及如何进行免疫原性检测要求的建议分散在众多指导文件中。为了能够评估免疫原性对安全性和疗效的影响，作者整合了监管指南中的建议，并介绍了免疫原性评估的当前方法和未来方向。
