Gottschalk, U., Brorson, K., Shukla, A. Innovation in biomanufacturing – the only way forward, Pharmaceutical Bioprocessing, 1(2), 141-157, 2013.

Abstract
Innovations in the biomanufacturing industry are predominantly incremental in nature, but there are occasional major technological shifts that occur as existing technologies reach their limits and as additional constraints are imposed by market forces or regulatory bodies. There tends to be a seismic effect to these disruptive innovations, forcing companies to adopt novel strategies and business models in order to remain competitive. In this article, we discuss how technological innovation can address some of the current challenges in biopharmaceutical manufacturing by anticipating shifts in market dynamics and cost structures. We consider bioprocessing standards, unit operations, best practices, enabling technologies and look at potential entry points for innovation where technologies are likely to evolve incrementally and where more disruptive, radical changes may flourish, including quality by design and process analytical technology. We conclude that the biomanufacturing industry can only thrive by embracing innovation and becoming more adaptable in the changing market environment.

Keywords
Bioprocessing standards; Biopharmaceutical manufacturing; Unit operations; Enabling technologies

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