title: Considerations About Pollen Used for the Production of Allergen Extracts.
abstract: Pollen is a biological product obtained to manufacture tree, weed, and grass allergen extracts, used to diagnose and treat allergies. Genetic and environmental factors affect the composition of pollen, e.g., the plant varieties from which pollen are obtained, weather, and levels of air pollution during plant growth. Therefore, appropriate guidelines and training of personnel to perform the activities associated with pollen are essential to produce appropriate allergen extracts. Various regulatory institutions, which vary in different countries, including the Food and Drug Administration (FDA) in the USA, control how such products should be produced. For example, the FDA regulates the manufacturing of pollen extracts but not the quality of the pollen used to prepare them, relying on each manufacturer to set its own standards to do so. To the contrary, European regulatory agencies, including the European Medicines Agency, control both the quality of the pollen and the manufacturing process to produce pollen extracts. Regulatory agencies, allergen manufacturers, scientific institutions, and pollen collection entities should collaborate to develop and implement guidelines appropriate for worldwide use for both the collection and processing of pollen raw materials. This article provides an overview of the subject of pollen for use in allergen extracts.
authors.affiliation: Allergen Science and Consulting, Lenoir, NC; Division of Allergy and Immunology, Department or Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Fla. Electronic address: rosacodina@allergenscienceandconsulting.com.
authors.forename: Rosa
authors.initials: R
authors.lastname: Codina
authors.affiliation: Retired mycologist.
authors.forename: Rodger C
authors.initials: RC
authors.lastname: Crenshaw
authors.affiliation: Division of Allergy and Immunology, Department or Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Fla.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Lockey
mesh_terms: D000485:Allergens / Q000276:immunology / Q000378:metabolism*; D052179:Antigens, Plant / Q000276:immunology / Q000378:metabolism*; D005060:Europe; D033161:Government Regulation; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D010936:Plant Extracts / Q000276:immunology / Q000378:metabolism*; D011058:Pollen / Q000276:immunology / Q000378:metabolism*; D017410:Practice Guidelines as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis* / Q000453:epidemiology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000485:Allergens; D052179:Antigens, Plant; D010936:Plant Extracts; D007073:Immunoglobulin E
keywords: Allergen extracts; Allergen extracts manufacturers; Pollen collection; Pollen raw materials; Regulations