Company: Gilead Sciences
Liaison(s): Gayle Derfus, Rajesh Krishnan, (fall project);, Jared Broddrick, Michael Molony, (spring project)
Gilead Sciences is a biopharmaceutical company that researches, develops and markets innovative treatments for life-threatening diseases. Gilead’s therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation. Since their founding 25 years ago, Gilead Sciences has grown rapidly, with a portfolio of 15 marketed products and a growing pipeline of investigational drugs and approximately 5,000 employees across four continents. Process development for monoclonal antibody (mAb) production is a time-consuming, labor intensive and expensive effort due to the number and complexity individual steps involved. To prevent bottlenecks and ensure commercial viability of future monoclonal antibody manufacturing, it is important to accelerate the development of both upstream and downstream processes, as well as to improve process analytics at each step. The Fall Gilead TMP provided an exhaustive assessment of recent innovations in mammalian cell line development for mAb production. Commercially available mammalian expression technologies for mAb products were identified and compared. The team provided a recommended list of top mAb expression systems which provide outstanding features and have a large client base. This analysis provides Gilead Sciences with cell line options which are friendly to regulatory agencies and have a proven performance in antibody production. For the Spring TMP Project, the team identified, evaluated and made recommendations for high throughput analytical technologies which can be used for rapid bioprocess development at Gilead. The recommendations were based on the need to optimize the bioprocess design space (QbD enabling), easily integrate into high-throughput upstream and downstream technologies and provide resource efficiency. In support of this objective, the team explored high throughput technologies being developed at a number of academic institutions and companies. To provide a detailed analysis of each technology, the team conducted detailed interviews with scientists developing these high throughput platforms. Finally, the team provided Gilead with a report which included a detailed evaluation and recommendation of technologies which could be integrated into their processes and optimize their bioprocess design space.