Løwenstein H, Larsen J N
ALK-Abelló A/S, Bøge Allé 6-8, 2970 Hørsholm, Denmark.
Curr Allergy Asthma Rep. 2001 Sep;1(5):474-9. doi: 10.1007/s11882-001-0036-0.
Recombinant allergens are genetically engineered isoforms representing allergen molecules from allergen extracts. Immunologic responses of allergic patients toward allergen extracts define the major allergens. For the average allergic patient, the diagnostic sensitivity and treatment efficacy correlate with the concentration of major allergen. Standardization of allergen products (extracts or genetically engineered allergens) can therefore advantageously be performed using a selected recombinant major allergen as a standard. The standardization will furthermore require reagents for which both monospecific, monoclonal, or preferably, recombinant antibodies can be used. Due to differences in the allergenic activity of individual isoallergens and the naturally occurring mixture of isoallergens found in an allergen extract, and due to additional contribution to the allergenic activity from other molecules in the extract, a biologic potency assessment must always be performed as a supplement. This is also the case for a genetically engineered allergen product.
重组变应原是通过基因工程改造的异构体，代表变应原提取物中的变应原分子。过敏患者对变应原提取物的免疫反应确定了主要变应原。对于普通过敏患者，诊断敏感性和治疗效果与主要变应原的浓度相关。因此，使用选定的重组主要变应原作为标准，可以有利地对变应原产品（提取物或基因工程变应原）进行标准化。此外，标准化还需要能够使用单特异性、单克隆或优选重组抗体的试剂。由于各个同种变应原的变应原活性存在差异，以及变应原提取物中天然存在的同种变应原混合物不同，并且由于提取物中其他分子对变应原活性的额外贡献，必须始终进行生物效价评估作为补充。基因工程变应原产品也是如此。
