Continuous Manufacturing: A Changing Processing Paradigm Publication
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation challenges limit continuous applications for biologics manufacturing. While only a few approved biologic products in the market-less than 10%, according to estimates by Eric Langer, managing partner, BioPlan Associates-are manufactured through perfusion or continuous downstream processing, the field is evolving (1). Most of these processes are done piecewise, however, and are not truly continuous.