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Current Allergy and Asthma Reports
Erschienen in: Current Allergy and Asthma Reports 7/2015

01.07.2015 | Immunologic/Diagnostic Tests in Allergy (M Chapman and A Pomés, Section Editors)

Control Process for Manufacturing and Standardization of Allergenic Molecules

verfasst von: Jerónimo Carnés, Víctor Iraola, Mayte Gallego, Jose R. Leonor

Erschienen in: Current Allergy and Asthma Reports | Ausgabe 7/2015

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Abstract

It is widely accepted that the success of the allergen immunotherapy (AIT), beyond clinical parameters such as dose, dosage regimen, or compliance, depends on the quality and composition of the final products used in the vaccines. Allergenic vaccines are pharmaceutical preparations derived from the natural sources which contain the allergenic components responsible for allergic sensitization. The selection of the appropriate allergenic sources must be a requirement. They suffer a dramatic transformation during the manufacturing process which renders a biologically standardized final product. The inclusion of the appropriate control analyses in the manufacturing process has demonstrated to be an efficient method to guarantee the quality and homogeneity of the final product as well as being a very useful tool for saving time and money. In this context, in the last years, the Regulatory Agencies have released specific guidelines to guarantee the manufacturing of the most appropriate products for the treatment of patients.
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Metadaten
Titel
Control Process for Manufacturing and Standardization of Allergenic Molecules
verfasst von
Jerónimo Carnés
Víctor Iraola
Mayte Gallego
Jose R. Leonor
Publikationsdatum
01.07.2015
Verlag
Springer US
Erschienen in
Current Allergy and Asthma Reports / Ausgabe 7/2015
Print ISSN: 1529-7322
Elektronische ISSN: 1534-6315
DOI
https://doi.org/10.1007/s11882-015-0541-1

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