The article explores the promise and challenges of continuous manufacturing (CM) for biotechnology. CM in biotech offers the potential for greater product quality while reducing costs and shortening time to market. Challenges to be overcome include research and development efforts to characterize certificates of pharmaceutical products (CPPs) on single-unit operations and integrate them into the process; integrated control strategies or operations; technology available on the market; approaches to validation and quality; and regulatory compliance.
The article clearly confirms that efforts are underway to have continuous manufacturing in biotechnology, but not all the process steps are ready for a CM implementation. The authors describe well the challenges and the work ahead that we have to undertake in the industry. The article deserves the award because it is encouraging readers to invest time, science, and technology to achieve continuous manufacturing in biotechnology.”
Ferdinando Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharmaceutical Engineering Committee (PEC)
About the Award
ISPE’s Roger F. Sherwood Article of the Year award was established in 1993 to increase article submissions and improve the quality of those received. In the early years, judges rated each issue's technical articles against a set of six criteria, then selected an annual winner.
Two decades later, while recognizing the merit of the original intent, the award has been refreshed to showcase the best content in Pharmaceutical Engineering, increase industry recognition, highlight ISPE’s reputation as a global knowledge leader, and bolster magazine content quality.
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