By Floris De Smet, Juan Pablo Acosta-Martinez, Nick Hutchinson, Christel Fenge and Miriam Monge
The pipeline of biopharmaceutical drugs is rich and becoming increasingly diverse. Many new biologic modalities are being developed as established therapeutic classes move through their lifecycle. Wide arrays of different types of molecules are expected to coexist within product portfolios and manufacturing networks. It is clear that this will have a significant impact on manufacturing facilities. Strategies need to be developed to prepare facilities for these challenges.
Single-use technologies have received considerable attention in recent years as a great platform to tackle the multi-modality manufacturing conundrum. These technologies can be used to reduce time to clinic, delay investment decisions and allow a high degree of operational flexibility. Over the last decade, single-use solutions for virtually every bioprocess unit operation have been developed and considerable investments have been made by the industry into optimizing the quality and supply chain that underpin this technology (Cappia et al., 2014).