A Binding Potency Assay for Pritumumab and Ecto-Domain Vimentin.

Publication Title

Methods in molecular biology (Clifton, N.J.)

Authors

Ivan Babic, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Santa Monica, CA, USA.Follow
Santosh Kesari, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Santa Monica, CA, USA.Follow
Mark C Glassy, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Santa Monica, CA, USA.

Document Type

Article

Publication Date

1-1-2019

Keywords

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

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.

Area of Special Interest

Neurosciences (Brain & Spine)

Specialty/Research Institute

Neurosciences