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Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project

Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project
Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project
Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States. In some key parts, requirements in these areas are harmonized while other fields are regulated separately between both regions. Essential differences are found in the use of Reference Preparations, or the requirement to apply standardized assays for potency determination. Since the types of products available are different in specific regions, regulatory guidance for such products may also be available in one specific region only, such as for allergoids in the European Union. Region-specific issues and priorities are a result of this. As allergen products derived from natural sources are inherently variable in their qualitative and quantitative composition, these products present special challenges to balance the variability and ensuring batch-to-batch consistency. Advancements in scientific knowledge on specific allergens and their role in allergic disease will consequentially find representation in future regulatory guidelines.
0105-4538
Bonertz, A.
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Goldstein, J.
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Hamerlijnk, D.
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Agache, I.
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Casale, T.
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Fernandez-Rivas, M.
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Halken, S.
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Jutel, M.
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Muraro, A.
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Vieths, S.
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Bonertz, A.
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Hoefnagel, M
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Goldstein, J.
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Poulsen, L.K.
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Van Ree, R.
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Rhyner, Claudio
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Barber, D.
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Palomares, O.
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Pawankar, R.
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Casale, T.
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Fernandez-Rivas, M.
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Jutel, M.
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Lau, S.
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Pajno, G.
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Sturm, G.
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Varga, E.-M.
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Gerth van Wijk, R.
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Bonini, S.
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Muraro, A.
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Vieths, S.
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Bonertz, A., Roberts, G., Slater, J.E., Bridgewater, J., Rabin, R., Hoefnagel, M, Timon, M., Pini, C., Pfaar, O., Sheikh, A., Ryan, D., Akdis, C.A., Goldstein, J., Poulsen, L.K., Van Ree, R., Rhyner, Claudio, Barber, D., Palomares, O., Pawankar, R., Hamerlijnk, D., Klimek, L., Agache, I., Angier, E., Casale, T., Fernandez-Rivas, M., Halken, S., Jutel, M., Lau, S., Pajno, G., Sturm, G., Varga, E.-M., Gerth van Wijk, R., Bonini, S., Muraro, A. and Vieths, S. (2018) Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project Allergy (doi:10.1111/all.13357).

Record type: Article

Abstract

Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States. In some key parts, requirements in these areas are harmonized while other fields are regulated separately between both regions. Essential differences are found in the use of Reference Preparations, or the requirement to apply standardized assays for potency determination. Since the types of products available are different in specific regions, regulatory guidance for such products may also be available in one specific region only, such as for allergoids in the European Union. Region-specific issues and priorities are a result of this. As allergen products derived from natural sources are inherently variable in their qualitative and quantitative composition, these products present special challenges to balance the variability and ensuring batch-to-batch consistency. Advancements in scientific knowledge on specific allergens and their role in allergic disease will consequentially find representation in future regulatory guidelines.

Text II_EAACI_TF_Allergen_manufacturing_issues_V102017_Consolidated - Accepted Manuscript
Restricted to Repository staff only until 17 November 2018.
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Text II - EAACI TF - Allergen manufacturing issues_V102017_Consolidated
Restricted to Repository staff only
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More information

Accepted/In Press date: 12 November 2017
e-pub ahead of print date: 10 January 2018

Identifiers

Local EPrints ID: 416156
URI: https://eprints.soton.ac.uk/id/eprint/416156
ISSN: 0105-4538
PURE UUID: 5ff2eecc-2eb3-4ba5-9565-85f502c64c2d

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Date deposited: 06 Dec 2017 17:30
Last modified: 16 Feb 2018 17:31

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Contributors

Author: A. Bonertz
Author: G. Roberts
Author: J.E. Slater
Author: J. Bridgewater
Author: R. Rabin
Author: M Hoefnagel
Author: M. Timon
Author: C. Pini
Author: O. Pfaar
Author: A. Sheikh
Author: D. Ryan
Author: C.A. Akdis
Author: J. Goldstein
Author: L.K. Poulsen
Author: R. Van Ree
Author: Claudio Rhyner
Author: D. Barber
Author: O. Palomares
Author: R. Pawankar
Author: D. Hamerlijnk
Author: L. Klimek
Author: I. Agache
Author: E. Angier
Author: T. Casale
Author: M. Fernandez-Rivas
Author: S. Halken
Author: M. Jutel
Author: S. Lau
Author: G. Pajno
Author: G. Sturm
Author: E.-M. Varga
Author: R. Gerth van Wijk
Author: S. Bonini
Author: A. Muraro
Author: S. Vieths

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