The conclusion of a biologic's lifecycle : manufacturing sourcing strategies on the eve of follow-on biologics

Abstract

The Amgen Rhode Island facility is dedicated to the production of the biological bulk drug substance (BDS) for Enbrel® (etanercept), which blocks the action of one's immune system, helping to treat immune diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. A productivity process improvement is currently being implemented that will change the manufacturing capacity of the production process at each of the three separately owned manufacturing facilities for Enbrel® BDS. Given that the Amgen Rhode Island facility currently only produces Enbrel® BDS, the Rhode Island facility has the largest capacity of all the BDS manufacturers, and that Enbrel®'s initial patent expires at the end of 2012; product sourcing is a major concern for both the Rhode Island site and the Enbrel® supply network.As biopharmaceutical companies shift their focus more toward more efficient production operations, issues such as diminishing productivity in drug development and the impact of an emerging follow-on biologics market are becoming critical factors in determining a company's long-term growth and sourcing strategy. This research examines both the qualitative and quantitative components that go into strategic sourcing decisions that are made by innovative biological therapeutic producers. This thesis develops a methodology and framework for strategic sourcing decisions and guidelines for selecting, implementing, and managing relationships within a biotechnological manufacturing network of separately owned facilities as applied to the Enbrel® BDS case study.