Year: 2021-22

Company: Amgen

Liaison(s): Christopher Borths, Janine Tom, Ed Wong

A biotechnology leader, Amgen is a global biopharmaceutical company founded in 1980 with a deep commitment to serving patients through discovering, developing, manufacturing, and delivering innovative therapies to address human disease. The therapeutic areas include cardiovascular disease, oncology, bone health, neuroscience, nephrology, and inflammation. Amgen is currently exploring novel biologics development and manufacturing for multispecific protein therapeutics. With its wide range of applications, including delivering payloads to targeted sites and redirecting T-cells to tumor cells, multispecific therapeutics have been shown to be effective for various clinical indications such as oncology. However, due to the likelihood of aggregation, potential immunogenicity, among other issues, this area of therapeutics development remains an active, ongoing research challenge. The Amgen Evaluation of Bioconjugation Technologies TMP Team was tasked with the construction of a state-of-the-art bioprocessing and conjugation chemistry process model, based on the evaluation of protein production options and suitable chemical conjugation technologies for commercial manufacturing. To fulfill these objectives, the Amgen TMP team reviewed and analyzed published literature on current, emerging, and future-forward technologies for the production and conjugation of relevant classes of proteins. Additionally, the team estimated projected yields, analyzed process feasibility, and conducted a Cost of Goods Manufactured (COGM) analysis on production and conjugation methods for large scale manufacturing based on determined criteria. Completion of this project is expected to provide Amgen with insights on the technologies and production of multispecific protein conjugates that have the potential for a broad application to future therapeutics through modular molecule design and site-specific control.