Rapid identification of anti-idiotypic mAbs with high affinity and diverse epitopes by rabbit single B-cell sorting-culture and cloning technology

PLoS One. 2020 Dec 21;15(12):e0244158. doi: 10.1371/journal.pone.0244158. eCollection 2020.

Abstract

The proactive generation of anti-idiotypic antibodies (anti-IDs) against therapeutic antibodies with desirable properties is an important step in pre-clinical and clinical assay development supporting their bioanalytical programs. Here, we describe a robust platform to generate anti-IDs using rabbit single B cell sorting-culture and cloning technology by immunizing rabbits with therapeutic drug Fab fragment and sorting complementarity determining regions (CDRs) specific B cells using designed framework control as a negative gate to exclude non-CDRs-specific B cells. The supernatants of cultured B cells were subsequently screened for binding to drug-molecule by enzyme-linked immunosorbent assay and the positive hits of B cell lysates were selected for cloning of their immunoglobulin G (IgG) variable regions. The recombinant monoclonal anti-IDs generated with this method have high affinity and specificity with broad epitope coverage and different types. The recombinant anti-IDs were available for assay development to support pharmacokinetic (PK) and immunogenicity studies within 12 weeks from the start of rabbit immunization. Using this novel rapid and efficient in-house approach we have generated a large panel of anti-IDs against a series of 11 therapeutic antibody drugs and successfully applied them to the clinical assay development.

MeSH terms

  • Animals
  • Antibodies, Anti-Idiotypic / genetics
  • Antibodies, Anti-Idiotypic / immunology*
  • Antibodies, Monoclonal / genetics
  • Antibodies, Monoclonal / immunology*
  • Antibody Affinity*
  • B-Lymphocytes / classification
  • B-Lymphocytes / immunology*
  • Cell Separation / methods*
  • Cells, Cultured
  • Cloning, Molecular / methods
  • Epitopes / genetics
  • Epitopes / immunology*
  • Humans
  • Immunoglobulin Variable Region / genetics
  • Immunoglobulin Variable Region / immunology
  • Rabbits

Substances

  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal
  • Epitopes
  • Immunoglobulin Variable Region

Grants and funding

All authors are employees at Genentech. The funder provided support in the form of salaries for all authors, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.