|The advances in biopharmaceutical production and manufacturing over the past decade or more form a complex array of interdisciplinary connections, new analytical technologies, emerging product/therapeutic modalities, and the influx of a new generation of bioprocessors who are stepping into legacy processes. The emphasis on streamlining and reducing time to market and controlling the final cost to patients occurs in parallel with attention to maintaining quality, safety, and comparability in well-controlled processes under the pervasive influence of the current quality-risk–based paradigm. In such an atmosphere of continuing innovation – including the emergence of biosimilars, cell therapies, and other newer technologies onto the markets – it can be hard to distinguish between truly new approaches and ongoing variations of the tried-and-true. In this chapter, survey respondents, BPI advisors, and former BPI authors provide a snapshot of industry progress and their visions of the manufacturing processes of the future.
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