Jerónimo Carnés1, Víctor Iraola2, Seong H Cho3, Robert E Esch4. 1. Research & Development Department, Laboratorios LETI, Madrid, Spain. Electronic address: jcarnes@leti.com. 2. Research & Development Department, Laboratorios LETI, Madrid, Spain. 3. Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Florida. 4. School of Natural Sciences, Lenoir-Rhyne University, Hickory, North Carolina.
Abstract
OBJECTIVE: 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. DATA SOURCES: A PubMed search was performed using focused keywords combined with relevant regulatory documents and industry guidelines. STUDY SELECTIONS: The information obtained through literature and specialized books was evaluated and combined with the personal expertise and experience of the authors. RESULTS: 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. CONCLUSION: 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.
OBJECTIVE: 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. DATA SOURCES: A PubMed search was performed using focused keywords combined with relevant regulatory documents and industry guidelines. STUDY SELECTIONS: The information obtained through literature and specialized books was evaluated and combined with the personal expertise and experience of the authors. RESULTS: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. CONCLUSION: 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.
Authors: Sara Huber; Gabriele Gadermaier; Barbara Bohle; Fatima Ferreira; Peter Briza Journal: World Allergy Organ J Date: 2021-02-26 Impact factor: 4.084
Authors: José L Justicia; Clara Padró; Albert Roger; Francisco Moreno; Manuel J Rial; Antonio Parra; Antonio Valero; Alfons Malet; Aina Teniente; Anna Boronat; Carla Torán-Barona Journal: World Allergy Organ J Date: 2021-06-06 Impact factor: 4.084