Biologics & Biosimilars

For both biologics and biosimilars, the inherent complexity and high-quality standards impose a substantial burden on their commercial scale manufacture, as even minor deviations in protein expression, isolation, and purification may lead to differences in the structure, reactivity, stability, and other quality aspects of the end product, causing lot-to-lot variations. Any of these differences has the potential to affect the treatment’s safety, efficacy, and shelf life, and to increase the risk of an unwanted immune system response.

For these reasons, the cost to reliably manufacture these biopharmaceuticals at commercial scale is generally quite high. As biosimilars emerge, the necessity to achieve parity on purity and efficacy at a lower price point is paramount, wherein the necessary cost reductions will be derived from increases to purity, yield and throughput and decreases to footprint, capital expenditure and operational expenditure with respect to the manufacturing line. It is clear that these cost reductions will only be attained through robust process innovations.