Standardisation of allergen products: 4. Validation of a candidate European Pharmacopoeia standard method for quantification of major grass pollen allergen Phl p 5-Reference-Cited by-同舟云学术

Standardisation of allergen products: 4. Validation of a candidate European Pharmacopoeia standard method for quantification of major grass pollen allergen Phl p 5

Published:2021-07-28 Issue:2 Volume:77 Page:633-642
ISSN:0105-4538
Container-title:Allergy
language:en
Short-container-title:Allergy

Author:

Zimmer Julia¹^ORCID,Schmidt Sandra¹,Kaul Susanne¹,Costanzo Angèle²,Buchheit Karl‐Heinz²,Brown Shannon³,Carnés Jerónimo⁴^ORCID,Chapman Martin⁵,Chen Aaron⁶,De Neergaard Michalade⁷,Döring Sascha¹,Hindley James Phillip⁸,Holzhauser Thomas¹,Jorajuria Sylvie²,Le Tallec David²,Lombardero Manuel⁹,Iacovacci Patrizia¹⁰,Reese Gerald¹¹,Sander Ingrid¹²^ORCID,Smith Bryan⁵,Strecker Daniel¹,Ree Ronald¹³,Zebina Myriam¹⁴,Vieths Stefan¹

Affiliation:

1. Paul‐Ehrlich‐Institut Langen Germany

2. European Directorate for the Quality of Medicines & HealthCare (EDQM) Strasbourg France

3. Jubilant HollisterStier Spokane WA USA

4. R&D Unit Allergy & Immunology. LETI Pharma Madrid Spain

5. Indoor Biotechnologies Charlottesville VA USA

6. Food and Drug Administration Silver Spring MD USA

7. ALK‐Abelló A/S Hørsholm Denmark

8. Indoor Biotechnologies Ltd Cardiff UK

9. ALK‐Abelló S.A Madrid Spain

10. ISS CNCF Roma Italy

11. Allergopharma GmbH & Co. KG Reinbek Germany

12. Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (IPA) Ruhr‐Universität Bochum Bochum Germany

13. Departments of Experimental Immunology and of Otorhinolaryngology Amsterdam University Medical Centers Amsterdam The Netherlands

14. Stallergenes Greer Antony Cedex France

Publisher

Wiley

Subject

Immunology,Immunology and Allergy

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.15003

Reference23 articles.

1. European Pharmacopoeia 10.4.Allergen Products 01\2019:1063.

2. CHMP.Guideline on allergen products: production and quality Issues 2007.

3. CHMP: Guideline on the clinical development of medicinal products for the treatment of allergic rhinoconjunctivitis.2004.

4. CHMP: Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases.2007.

5. Standardization and Regulation of Allergen Products in the European Union

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