KJM: Do you foresee a lot of advances in fundamental and applied glycosylation science on the horizon?

RJ: These developments can be anticipated to have a significant impact on antibody performance and ultimately on the cost of goods. They will also be applied for the improvement of other biologics. Thus, glycosylation has profound effects on the performance of erythropoietin (EPO). Amgen has recognized this and has re-engineered the molecule to introduce two extra glycosylation sites. The product has improved biologic efficacy and a longer half-life.

The next challenge is the development of biosimilars and competition in the marketplace resulting in a lowering of costs. Competition will come from low-cost economies; even if not licensed within the US, they will compete since they will be available from the web.