Research & Development Department, Laboratorios LETI, Madrid, Spain.
Research & Development Department, Laboratorios LETI, Madrid, Spain.
Ann Allergy Asthma Immunol. 2017 Mar;118(3):249-256. doi: 10.1016/j.anai.2016.08.018.
To provide physicians, researchers, and other interested health care professionals with information about how mite source materials and allergen extracts are manufactured, including the critical process parameters that can affect the final composition of allergenic extracts available for clinical use.
A PubMed search was performed using focused keywords combined with relevant regulatory documents and industry guidelines.
The information obtained through literature and specialized books was evaluated and combined with the personal expertise and experience of the authors.
Dermatophagoides farinae and Dermatophagoides pteronyssinus are the primary species responsible for allergen sensitizations and allergy symptoms in genetically predisposed individuals. Storage mites belonging to the families Glycyphagidae, Echimyopodidae, and Acaridae can also be relevant sources of indoor mite allergens. The cultivation and purification processes used to produce mite raw materials play a critical role in the final composition of mite allergen extracts. Mite extract standardization in the United States is based on total allergenic activity with respect to a single national standard, whereas in Europe consistency is ensured by in-house standards and international references. Because of the limitation of allergen avoidance and pharmacotherapy for patients with severe allergic rhinitis and asthma, house dust mite subcutaneous immunotherapy or sublingual immunotherapy can be an invaluable treatment option for them.
Differences in manufacturing processes and extract standardization approaches may lead to differences in extract quality and potency. Physicians should be aware of these potential sources of mite extract variability. Use of well-standardized house dust mite extracts would be critical for success in the diagnosis and treatment of house dust mite allergy.
为医生、研究人员和其他有兴趣的医疗保健专业人员提供有关螨源材料和变应原提取物如何制造的信息,包括可能影响可用于临床使用的变应原提取物最终成分的关键工艺参数。
使用聚焦关键词对 PubMed 进行了搜索,同时结合了相关的监管文件和行业指南。
通过文献和专业书籍获得的信息进行了评估,并结合了作者的个人专业知识和经验。
粉尘螨和屋尘螨是导致遗传易感性个体过敏致敏和过敏症状的主要物种。属于 Glycyphagidae、Echimyopodidae 和 Acaridae 科的贮藏螨也可能是室内螨变应原的相关来源。用于生产螨原料的培养和提纯过程对螨变应原提取物的最终成分起着至关重要的作用。美国的螨提取物标准化是基于对单一国家标准的总变应原活性,而在欧洲则通过内部标准和国际参考来确保一致性。由于严重过敏性鼻炎和哮喘患者对过敏原回避和药物治疗的限制,屋尘螨皮下免疫治疗或舌下免疫治疗可能是他们非常宝贵的治疗选择。
制造工艺和提取物标准化方法的差异可能导致提取物质量和效力的差异。医生应了解螨提取物变异性的这些潜在来源。使用经过良好标准化的屋尘螨提取物对于屋尘螨过敏的诊断和治疗的成功至关重要。