Company: Amgen, Inc.
Liaison(s): Natalia Gomez
Amgen focuses on areas of high-unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology innovator since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, reaching millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen manufactures in multiple modalities ranging from small molecule to bispecific antibodies. Amgen is now focusing on next-gen products and are evaluating the potential of T-cell therapeutics. Amgen asked the KGI TMP team to provide insights on a manufacturing process for a potential therapeutic. The project entailed an extensive evaluation of a manufacturing process for T-cell therapies, from isolation/enrichment to final formulation.
This TMP project also evaluated manufacturing processes for the gene delivery platform, including both viral and non-viral approaches. A process flow diagram for each platform was created to include main unit operations, equipment, and raw materials. The project is to conclude with a high-level recommendation for a basic plant design to include manufacturing of a gene delivery platform and T-cell therapeutics.