Year: 2017-18

Company: Gilead Sciences

Liaison(s): Brian Doyle, Brian Kluck

Gilead develops and commercializes innovative medicines in diverse therapeutic areas: HIV/AIDS, liver disease, hematology and oncology, cardiovascular disease, as well as inflammation and respiratory health. Gilead continues to explore the therapeutic potential of biologics in these areas, including multiple monoclonal antibodies and cell therapies currently in clinical trials. As the realm of biologic modalities Gilead investigates expands and diversifies, there is a need to assess the feasibility, operation, and economics of a new clinical manufacturing facility that can accommodate the multi faceted needs of a transformative biologics pipeline.

This Team Master’s Project was focused on developing a comprehensive design of a flexible, single-use manufacturing facility to accommodate products of multiple modalities. This facility will have the ability to support drug substance manufacturing from upstream through downstream processes that can provide appropriate product yields for clinical phase I through clinical phase III scales.

This TMP will deliver a comprehensive manufacturing facility design and demonstrate its flexibility by illustrating various processes, including low and high titer monoclonal antibody production processes and multi-modality processes that can be simultaneously run within this facility at any given time. The team will further conduct in-depth process scale calculations to demonstrate the flexibility of the facility and process economics analyses to reveal the cost-effectiveness of this facility.