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Background <p>Determining total allergenic potency is key in standardization of active substances being a&#xa0;prerequisite in achieving acceptable batch-to-batch consistency of allergen products. Currently, a&#xa0;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&#xa0;E) pools, providing a&#xa0;more standardized approach for determining the potency of allergen immunotherapy products.</p> Methods <p>Human IgE mAbs targeting individual <i>Apis mellifera</i> 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.</p> Results <p>Initial results indicate that the recombinant antibody pool mirrors the allergen specificity of human serum pools.</p> Conclusion <p>Recombinant antibody pools presenting a&#xa0;viable alternative for allergen potency testing and ensuring consistent product quality.</p>

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Innovation in the standardization of insect venom immunotherapy preparations

  • 期刊论文

  • 发表日期：

    2025年10月29日

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  • Lizzy Wanka,
  • Anders Lund,
  • Sofie Degn-Petersen,
  • Tiffany Sztuk,
  • Jacob Ihlemann

摘要

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.