Development And Production of VRC01 anti-HIV Broadly Neutralizing Antibody

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

This project is designed to prepare cGMP quality investigational VRC01 monoclonal antibody and complete the preclinical and laboratory studies needed to begin a clinical trial. This will involve all development activities starting at cell line development through scale-up, assay development, manufacturing bulk and filled product and long-term stability studies for clinical use of the product. The first clinical trial is a Phase I study to examine safety and dose ranging of VRC01 for further clinical investigation. Clinical materials are being manufactured in compliance with current Good Manufacturing Practices (cGMP) and released for use in Phase I clinical trials.