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A Binding Potency Assay for Pritumumab and Ecto-Domain Vimentin

  • Ivan Babic
  • Santosh Kesari
  • Mark C. Glassy
Protocol
Part of the Methods in Molecular Biology book series (MIMB, volume 1904)

Abstract

Pritumumab, a natural human IgG1kappa mAb, was isolated from the regional lymph node of a patient with cervical cancer. This antibody has been reported to bind the cytoskeletal protein vimentin, and to cell surface expressed vimentin referred to as ecto-domain vimentin (EDV). Here, we report details of the development of a potency of binding assay for pritumumab as a prerequisite before pursuing clinical trials. The enzyme linked immunosorbent assay (ELISA) to detect antibody-binding antigen can serve as a potency assay for release of manufactured samples to be used in clinical studies. Several layers of controls for this assay along with suitability testing for reagents and components of the assay must be developed before the assay can be incorporated for stability testing and release of manufatured samples.

Key words

Pritumumab Ecto-domain vimentin Enzyme linked immunosorbent assay (ELISA) Potency assay Investigational new drug (IND) Good laboratory practices (GLP) 

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Ivan Babic
    • 1
  • Santosh Kesari
    • 1
  • Mark C. Glassy
    • 1
    • 2
    • 3
  1. 1.Department of Translational Neurosciences and NeurotherapeuticsJohn Wayne Cancer InstituteSanta MonicaUSA
  2. 2.Translational Neuro-Oncology LaboratoryUCSD Moores Cancer CenterLa JollaUSA
  3. 3.Nascent Biotech, Inc.San DiegoUSA

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