Chamberlain P, Mire-Sluis A R
MDS Pharma Services, Wokingham, Berks., United Kingdom.
Dev Biol (Basel). 2003;112:3-11.
Immunogenicity of biological products can occur pre-clinically and clinically when products elicit immune responses in animals or humans receiving the products. This is a concern for manufacturers, regulatory agencies and clinicians as immune responses can result in effects on product effectiveness and safety. The clinical sequelae of immunogenicity range from no effects to serious, life-threatening syndromes. However, although many biological products are immunogenic to some extent, it is quite rare that immunogenicity leads to serious adverse events. Whilst there are methods to detect immunogenicity, they currently rely on detecting the humoral rather than the cellular response of the immune system. The design and validation of assays such as immuno-assays and bio-assays are critical for a meaningful assessment of immunogenicity. There are a growing number of computational and laboratory-based methods for the prediction of immunogenicity, as well as methods to reduce potential immunogenicity and these may lead to less immunogenic biological products in future.
生物制品的免疫原性可在临床前和临床阶段出现，即当产品在接受该产品的动物或人类中引发免疫反应时。这是制造商、监管机构和临床医生所关注的问题，因为免疫反应可能会对产品的有效性和安全性产生影响。免疫原性的临床后果从无影响到严重的、危及生命的综合征不等。然而，尽管许多生物制品在一定程度上具有免疫原性，但免疫原性导致严重不良事件的情况相当罕见。虽然有检测免疫原性的方法，但目前这些方法依赖于检测免疫系统的体液反应而非细胞反应。免疫测定和生物测定等检测方法的设计和验证对于有意义地评估免疫原性至关重要。用于预测免疫原性的计算方法和基于实验室的方法越来越多，同时也有降低潜在免疫原性的方法，这些可能会在未来带来免疫原性更低的生物制品。
