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Production and characterization of a human antisperm monoclonal antibody against CD52g for topical contraception in women. | LitMetric

AI Article Synopsis

  • Around 40% of pregnancies are unintended, highlighting the need for better contraception, leading to the development of a human monoclonal antibody (mAb) for on-demand topical use via a Nicotiana production platform.
  • The mAb, known as Human Contraception Antibody (HCA), demonstrated effective sperm agglutination and immobilization in various tests while maintaining safety in human vaginal tissue models.
  • HCA shows significant promise as a female contraceptive due to its effectiveness and good safety profile, supported by funding from the National Institutes of Health.

Article Abstract

Background: Approximately 40% of human pregnancies are unintended, indicating a need for more acceptable effective contraception methods. New antibody production systems make it possible to manufacture reagent-grade human monoclonal antibodies (mAbs) for clinical use. We used the Nicotiana platform to produce a human antisperm mAb and tested its efficacy for on-demand topical contraception.

Methods: Heavy and light chain variable region DNA sequences of a human IgM antisperm antibody derived from an infertile woman were inserted with human IgG constant region sequences into an agrobacterium and transfected into Nicotiana benthamiana. The product, an IgG mAb ["Human Contraception Antibody" (HCA)], was purified on Protein A columns, and QC was performed using the LabChip GXII Touch protein characterization system and SEC-HPLC. HCA was tested for antigen specificity by immunofluorescence and western blot assays, antisperm activity by sperm agglutination and complement dependent sperm immobilization assays, and safety in a human vaginal tissue (EpiVaginal™) model.

Findings: HCA was obtained at concentrations ranging from 0.4 to 4 mg/ml and consisted of > 90% IgG monomers. The mAb specifically reacted with a glycan epitope on CD52g, a glycoprotein produced in the male reproductive tract and found in abundance on sperm. HCA potently agglutinated sperm under a variety of relevant physiological conditions at concentrations ≥ 6.25 µg/ml, and mediated complement-dependent sperm immobilization at concentrations ≥ 1 µg/ml. HCA and its immune complexes did not induce inflammation in EpiVaginal™ tissue.

Interpretation: HCA, an IgG1 mAb with potent sperm agglutination and immobilization activity and a good safety profile, is a promising candidate for female contraception.

Funding: This research was supported by grants R01 HD095630 and P50HD096957 from the National Institutes of Health.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324805PMC
http://dx.doi.org/10.1016/j.ebiom.2021.103478DOI Listing

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