The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing

By Nigel Darby, Senior Advisor, Cytiva

For many years, the biopharmaceutical industry has been predominately occupied by antibodies, which has strengthened our knowledge and expertise about how to successfully bring them to market. Now, pipelines are filling with innovative and potentially groundbreaking molecules tackling many unmet medical needs. As the complexity of these molecules increases, so do their development processes and the unique challenges that accompany them. The inherent vulnerability of these increasingly difficult processes makes them susceptible to even the slightest change, renewing anxiety over the long-standing issue of managing raw material variation and process risks.

With biologics predicted to contribute to 52 percent of the top 100 product sales by 2022,¹ we must ask ourselves: is the biopharmaceutical supply chain fit for purpose given the growth of our industry, and can we still use it to serve the millions of patients who depend on us? Answering these questions requires a look back at how far we have come in raw material supply management and what still needs to be accomplished to ensure the delivery of safe and effective drugs.