Robert E Esch1, Rosa Codina2. 1. School of Natural Sciences, Lenoir-Rhyne University, Hickory, North Carolina. Electronic address: resch12@charter.net. 2. Allergen Science and Consulting, Lenoir, North Carolina; Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Florida.
Abstract
OBJECTIVE: To review the topic of fungal raw materials used for the production of allergen extracts and the associated challenges and highlight candidate areas for development before standardized fungal allergen extracts can be commercially produced. DATA SOURCES: A PubMed search was performed using focused keywords and combined with a review of regulatory documents and industry guidelines. Several books on mycology also were consulted. STUDY SELECTIONS: The information obtained through the literature, books, and industry was scrutinized and combined with personal experience and expertise to write this article. RESULTS: Fungi are complex ubiquitous organisms on Earth. They are beneficial and detrimental for humans. Fungi can cause hypersensitivity reactions, including types I, III, and IV. The procurement of fungal raw materials to prepare allergen extracts for diagnosis and possible allergen immunotherapy is complex owing to the intrinsic nature of fungi and their complex genome. Allergen manufacturers produce allergen extracts with variable qualitative and quantitative compositions, which can lead to unpredictable clinical outcomes. CONCLUSION: The clinician should be aware of the factors responsible for the qualitative and quantitative compositions of fungal allergen extracts and the reasons that currently preclude their standardization. Scientific advances and collaboration and cooperation between allergen manufacturing companies and regulatory agencies are necessary to improve the quality and consistency of fungal extracts. Moreover, clinicians should understand the limitations of currently available fungal extracts.
OBJECTIVE: To review the topic of fungal raw materials used for the production of allergen extracts and the associated challenges and highlight candidate areas for development before standardized fungal allergen extracts can be commercially produced. DATA SOURCES: A PubMed search was performed using focused keywords and combined with a review of regulatory documents and industry guidelines. Several books on mycology also were consulted. STUDY SELECTIONS: The information obtained through the literature, books, and industry was scrutinized and combined with personal experience and expertise to write this article. RESULTS: Fungi are complex ubiquitous organisms on Earth. They are beneficial and detrimental for humans. Fungi can cause hypersensitivity reactions, including types I, III, and IV. The procurement of fungal raw materials to prepare allergen extracts for diagnosis and possible allergen immunotherapy is complex owing to the intrinsic nature of fungi and their complex genome. Allergen manufacturers produce allergen extracts with variable qualitative and quantitative compositions, which can lead to unpredictable clinical outcomes. CONCLUSION: The clinician should be aware of the factors responsible for the qualitative and quantitative compositions of fungal allergen extracts and the reasons that currently preclude their standardization. Scientific advances and collaboration and cooperation between allergen manufacturing companies and regulatory agencies are necessary to improve the quality and consistency of fungal extracts. Moreover, clinicians should understand the limitations of currently available fungal extracts.
Authors: Susann Forkel; Caroline Beutner; Silke S Schröder; Oliver Bader; Sidhi Gupta; Thomas Fuchs; Michael P Schön; Johannes Geier; Timo Buhl Journal: Int Arch Allergy Immunol Date: 2021-03-29 Impact factor: 2.749
Authors: Mark A Wurth; Azadeh Hadadianpour; Dennis J Horvath; Jacob Daniel; Olivia Bogdan; Kasia Goleniewska; Anna Pomés; Robert G Hamilton; R Stokes Peebles; Scott A Smith Journal: JCI Insight Date: 2018-10-18