Evidence map›Paper›PMID 34594335›Full record

ReviewFrontiers in immunology2021

The History, Present and Future of Allergen Standardization in the United States and Europe.

Julia Zimmer, Jennifer Bridgewater, Fatima Ferreira, Ronald van Ree, Ronald L Rabin, Stefan Vieths

Abstract readReview
In one paragraph

Review in Frontiers in immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
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  10. Article
  11. Review
  12. Article
  13. Review
  14. Allergen immunotherapy in China.Frontiers in allergy · 2023
    Review
  15. Review
  16. Manufacturing processes of peanut (Frontiers in allergy · 2022
    Article
  17. A recombinantFrontiers in immunology · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Julia ZimmerDivision of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
Jennifer BridgewaterDivision of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.
Fatima FerreiraDepartment of Biosciences, Paris Lodron University of Salzburg, Salzburg, Austria.
Ronald van ReeDepartment of Experimental Immunology and Department of Otorhinolaryngology, Amsterdam University Medical Centers, Amsterdam, Netherlands.
Ronald L RabinDivision of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.
Stefan ViethsPaul-Ehrlich-Institut, Langen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The topic of standardization in relation to allergen products has been discussed by allergists, regulators, and manufacturers for a long time. In contrast to synthetic medicinal products, the natural origin of allergen products makes the necessary comparability difficult to achieve. This holds true for both aspects of standardization: Batch-to-batch consistency (or product-specific standardization) and comparability among products from different manufacturers (or cross-product comparability). In this review, we focus on how the United States and the European Union have tackled the topic of allergen product standardization in the past, covering the early joint standardization efforts in the 1970s and 1980s as well as the different paths taken by the two players thereafter until today. So far, these two paths have been based on rather classical immunological methods, including the corresponding benefits like simple feasability. New technologies such as mass spectrometry present an opportunity to redefine the field of allergen standardization in the future.

Indexed as

Practice Guidelines as TopicQuality ControlAllergensDesensitization, ImmunologicEuropeHumansTechnology, PharmaceuticalUnited StatesAllergensallergen standardizationEuropeextractsmajor allergenUnited States

Identifiers

PMID34594335
PMCPMC8477030

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.