There has been a tremendous change over the last 40 years in the production of biopharmaceuticals, enabling the promise of the biotechnology industry to deliver biologics on a scale unimagined at the dawn of the industry.   As biopharmaceutical production has matured, the interplay between upstream and downstream development and manufacturing has continued to evolve.  This interplay has been affected both by increases of product titers during upstream processing and increases in production requirements overall.  As downstream processes have continued to address industry needs, they have evolved both independently and in concert with overall changes such as continuous processes, single use and other innovations.    In addition, the industry itself continues to evolve, with changes including biosimilars, new biologics modalities and delivery systems.   This talk will provide both an historical perspective and a look forward in the role of downstream processing in the ever-changing landscape of biopharmaceutical manufacturing.  Additionally, the downstream interplay with upstream approaches to biosimilars taking place at Momenta Pharmaceuticals will be discussed.

Downstream processes: Past, present and future

251st National Meeting (2016)

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