A human monoclonal antibody based immunoenzymetric assay to measure Fel d 1 concentrations in cat hair and pelt allergenic extracts.

Autor:	Rabin RL; Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (US-FDA), Silver Spring, MD, United States., Croote D; IgGenix Inc., South San Francisco, CA, United States., Chen A; Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (US-FDA), Silver Spring, MD, United States., Dobrovolskaia E; Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (US-FDA), Silver Spring, MD, United States., Wong JJW; IgGenix Inc., South San Francisco, CA, United States., Grossman J; IgGenix Inc., South San Francisco, CA, United States., Hamilton RG; Division of Allergy and Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in allergy [Front Allergy] 2024 Jul 15; Vol. 5, pp. 1417879. Date of Electronic Publication: 2024 Jul 15 (Print Publication: 2024).
DOI:	10.3389/falgy.2024.1417879
Abstrakt:	In the United States, 19 allergen extracts of different specificities are standardized, which means that their potencies are determined in comparison to a US reference standard. For cat allergen extracts, potency is determined by measuring Fel d 1 content expressed in in Fel d 1 units, and with a unitage that correlates with skin test reactions (bioequivalent allergy units or BAU). Currently, Fel d 1 content is measured with a radial immunodiffusion (RID) assay that uses polyclonal sheep antisera to detect the allergenic protein by producing a white precipitin line in agar gel. However, the RID is considered cumbersome, and the polyclonal sera may qualitatively vary among animals and may recognize epitopes irrelevant to human allergic disease. In this report, we describe a quantitative two-site immunoenzymetric assay (IEMA) for Fel d 1 that uses immobilized capture and soluble biotin-labeled detection Fel d 1-specific human IgE monoclonal antibodies (mAb) that have been class-switched to IgG4. Together, they sandwich Fel d 1 molecules from extracts. Using purified natural Fel d 1 as a calibrator, the historically reported ∼4 micrograms Fel d 1/Fel d 1 unit assignment was directly measured in this mAb-based IEMA at 3.12 ± 0.24 micrograms of Fel d 1 per Fel d 1 unit. This IEMA appears to be equivalent to RID in the measurement of biological potencies of commercial cat hair and cat pelt extracts marketed in the United States. Competing Interests: DC, JG, and JW are employees and stakeholders in IgGenix Inc. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision. The authors declare that this study received funding from IgGenix. The funder had the following involvement in the study: support for the discovery and characterization of the described antibodies. (© 2024 Rabin, Croote, Chen, Dobrovolskaia, Wong, Grossman and Hamilton.)
Databáze:	MEDLINE
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