Continuous Manufacturing in Biotech Processes
Article of the Year 2018 Winner:
The winner of the 2018 Roger F. Sherwood Article of the Year award is “Continuous Manufacturing in Biotech Processes: Challenges for Implementation” by Robert Dream, PE, CPIP; Christoph Herwig, PhD; and Emilie Pelletier.
The article explores the promise and challenges of continuous manufacturing (CM) for biotechnology. Continuous manufacturing 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 on single-unit operations and integrate them into the process; integrated control strategies for 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 continuous manufacturing implementation,” said Ferdinando Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharmaceutical Engineering Committee (PEC). “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.”
The 2018 Roger F. Sherwood Article of the Year award finalists are:
- “Heat Recovery Regulations and HVAC Energy Consumption” (May-June 2018)
Jim Heemer, PE, CEM, CEA, LEED-AP, and Hugh Reynolds
- “The Rise of Biopharmaceutical Manufacturing in Asia” (May-June 2018)
Scott Fotheringham, PhD
- “Transitioning to Multicolumn Chromatography: Real-World Challenges and Results” (May-June 2018)
Lindsay Arnold, PhD
- “Pharma 4.0: Hype or Reality?” (July-August 2018)
Lorenz Binggeli, Hans Heesakkers; Christian Wölbeling; and Thomas Zimmer, PhD
- “Getting Ready for Pharma 4.0: Data Integrity in Cloud and Big Data Applications” (September-October 2018)
Toni Manzano, PhD and Gilad Langer, PhD
- “Continuous Manufacturing In Biotech Processes: Challenges for Implementation” (November-December 2018)
Robert Dream, PE, CPIP; Christoph Herwig, PhD; and Emilie Pelletier.
About the Award
The Roger F. Sherwood Article of the Year award was established in 1993 to increase article submissions and improve the quality of those received. The award has been refreshed in recent years 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.
For the 2018 award, a subcommittee of the Pharmaceutical Engineering Committee served as judges. They reviewed 37 feature and technical articles published in Pharmaceutical Engineering during calendar year 2018 (volume 38). The Pharmaceutical Engineering Committee subcommittee was headed by Michelle Gonzalez.
The judges used the following criteria to assess articles: usefulness to ISPE readers; how the articles improve the knowledge of key topics; and clarity/ease of reading. The Article of the Year award winner was selected from the six finalists.