Year: 2013-14

Company: Gilead Sciences

Liaison(s): Danny Chou

Since 1987, Gilead Sciences has worked to discover, develop, and commercialize medications in order to advance the care of patients suffering from lifethreatening diseases in areas of unmet medical need. In just over 25 years, Gilead has become a leading biopharmaceutical company with a portfolio of 16 marketed products, a growing pipeline of investigational drugs and approximately 5,800 employees in offices across five continents. Gilead Science’s primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular, metabolic, and respiratory conditions. Gilead’s office in Oceanside, California is responsible for the clinical manufacture and process development of biologics candidates in preclinical, Phase 1 and Phase 2 testing. The Gilead Particulates TMP was asked to perform an in depth analysis of the biopharmaceutical industry’s efforts to use the characterization and quantitation of subvisible particulates as a tool to control the quality of biological drugs. The size and count of protein particle aggregates within biopharmaceutical formulations is a major quality concern which can negatively impact safety and/or efficacy of drug products. It is thus important to carefully monitor and characterize these particles. The current regulatory size limit for particles in formulation is 10 microns, as defined by FDA and ICH guidance. However, recent research has shown that this standard is not sufficient because of the prevalence of subvisible particles below 10 microns in size. The aim of this project was to assess the advancement in regulatory and industrial standards, as well as in technologies used to monitor these subvisible particles (SVPs) in parenteral drug products – within the size range of 0.1 to 10 microns. Through in-depth literature research and interviews with key opinion leaders (KOL) within academia, industry, the FDA, and commercial vendors, the team gained insight into the progress of regulatory standards and identified the latest technologies that are most suitable for use in the surveillance of SVPs. The results of this study were compiled into a final report, which was submitted to the team’s corporate liaison at the project conclusion.