Innovation in the standardization of insect venom immunotherapy preparations

Q3 Medicine
Lizzy Wanka, Anders Lund, Sofie Degn-Petersen, Tiffany Sztuk, Jacob Ihlemann
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引用次数: 0

Abstract

Background

Determining total allergenic potency is key in standardization of active substances being a prerequisite in achieving acceptable batch-to-batch consistency of allergen products. Currently, a human serum pool collected from allergic individuals serves as allergen-, recognizing antibodies for determining the total allergenic activity. Human serum presents disadvantages, including variability, ethical dilemmas, and limited availability. These drawbacks can be addressed by developing monoclonal antibody (mAb) IgE (immunoglobulin E) pools, providing a more standardized approach for determining the potency of allergen immunotherapy products.

Methods

Human IgE mAbs targeting individual Apis mellifera allergens were generated by performing single-cell RNA sequencing on honeybee venom specific memory B‑cells from beekeepers. MAbs were expressed in Expi293 HEK293 cells, with epitope binning and affinity assessment ensuring selection of functionally relevant antibodies for potency testing.

Results

Initial results indicate that the recombinant antibody pool mirrors the allergen specificity of human serum pools.

Conclusion

Recombinant antibody pools presenting a viable alternative for allergen potency testing and ensuring consistent product quality.

昆虫毒液免疫治疗制剂标准化的创新
背景:测定总致敏效力是原料药标准化的关键,是实现可接受的批间致敏原产品一致性的先决条件。目前,从过敏个体中收集的人类血清池作为过敏原,识别抗体以确定总过敏原活性。人血清存在缺点,包括可变性、伦理困境和有限的可用性。这些缺点可以通过开发单克隆抗体(mAb) IgE(免疫球蛋白E)池来解决,为确定过敏原免疫治疗产品的效力提供更标准化的方法。方法对养蜂人的蜂毒特异性记忆B细胞进行单细胞RNA测序,制备针对单个蜜蜂过敏原的人IgE单抗。单克隆抗体在Expi293 HEK293细胞中表达,通过表位结合和亲和力评估确保选择功能相关的抗体进行效价检测。结果初步结果表明,重组抗体库反映了人血清库的过敏原特异性。结论重组抗体池为过敏原效价检测提供了一种可行的替代方法,保证了产品质量的一致性。
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来源期刊
Allergo Journal International
Allergo Journal International Medicine-Immunology and Allergy
CiteScore
4.60
自引率
0.00%
发文量
31
期刊介绍: Allergo Journal International is the official Journal of the German Society for Applied Allergology (AeDA) and the Austrian Society for Allergology and Immunology (ÖGAI). The journal is a forum for the communication and exchange of ideas concerning the various aspects of allergy (including related fields such as clinical immunology and environmental medicine) and promotes German allergy research in an international context. The aim of Allergo Journal International is to provide state of the art information for all medical and scientific disciplines that deal with allergic, immunological and environmental diseases. Allergo Journal International publishes original articles, reviews, short communications, case reports, and letters to the editor. The articles cover topics such as allergic, immunological and environmental diseases, the latest developments in diagnosis and therapy as well as current research work concerning antigens and allergens and aspects related to occupational and environmental medicine. In addition, it publishes clinical guidelines and position papers approved by expert panels of the German, Austrian and Swiss Allergy Societies. All submissions are reviewed in single-blind fashion by at least two reviewers. Originally, the journal started as a German journal called Allergo Journal back in 1992. Throughout the years, English articles amounted to a considerable portion in Allergo Journal. This was one of the reasons to extract the scientific content and publish it in a separate journal. Hence, Allergo Journal International was born and now is the international continuation of the original German journal. Nowadays, all original content is published in Allergo Journal International first. Later, selected manuscripts will be translated and published in German and included in Allergo Journal.
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