In the past 10 years, continuous manufacturing (CM) has gone from theoretical discussion to manufacturing reality. However, the pharmaceutical industry has not yet explicitly defined the term “continuous manufacturing,” nor has it ensured that the term’s usage is aligned with other industries. If this problem is not corrected soon, it will lead to significant confusion. This is evidenced by recent articles that call into question whether the newly approved process for the production of Prezista by Janssen can be considered continuous.1,2 In this article, we will focus on one potential root source of the debate and attempt to identify the key tenets to properly define continuous manufacturing in the pharma industry.
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By Eric Jayjock, Ph.D., Patheon, and Keirnan LaMarche, Ph.D., Bristol-Myers Squibb
Pharmaceutical Online - August 30, 2016
http://www.pharmaceuticalonline.com/doc/what-is-continuous-manufacturing-anyway-agreeing-on-a-proper-definition-0001