By Avril Vermunt - Program Manager, Connected Biomanufacturing at GE Healthcare Life Sciences
In February 2019, the FDA released a statement regarding its approach to advancing pharmaceutical manufacturing. FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock acknowledged that one of the most important tool for modernizing the pharmaceutical industry’s approach to drug development is continuous manufacturing (CM). This alternative to traditional drug processing is a solution the industry has been driving toward for more than a decade. While implementing it requires time and money, CM is a key step toward promoting drug quality and improving manufacturing efficiency, which could ultimately lead to lower drug prices. This has become especially critical in the biomanufacturing industry, where treating rare and complex diseases often comes with a high price tag that many patients struggle to afford.
An enabler for CM is the concept of connected manufacturing, where continuous unit operations are connected not just physically but also digitally using automated solutions. This approach to drug production gives companies the ability to manage and maintain product quality from start to finish using a fully integrated and connected monitoring and controls system.
Interest in CM has grown considerably over the years, and the recent statement from the FDA shows the agency acknowledges it as a viable solution to advancing and modernizing drug manufacturing. Implementing, and even initially considering CM can be a daunting and sometimes overwhelming task; however, breaking it down into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.