Article of the Year
About the Roger F. Sherwood Article of the Year 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® magazine, increase industry recognition, highlight ISPE’s reputation as a global knowledge leader, and bolster magazine content quality.
About the 2018 Article of the Year
The winning article for the 2018 Roger F. Sherwood Article of the Year award was:
Continuous Manufacturing In Biotech Processes: Challenges for Implementation (November-December 2018)
Robert Dream, CPIP, PE, Christoph Herwig, PhD, and Emilie Pelletier
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,” 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 finalists were:
- 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 - WINNER: Continuous Manufacturing In Biotech Processes: Challenges for Implementation (November-December 2018)
Robert Dream, CPIP, PE, Christoph Herwig, PhD, and Emilie Pelletier
2018 JUDGING
A subcommittee of the Pharmaceutical Engineering® Committee (PEC) served as judges for the 2018 award competition, reviewing 37 feature and technical articles published by Pharmaceutical Engineering® during calendar year 2018 (volume 38). The PEC subcommittee was headed by Michelle Gonzalez.
The judges assessed the following criteria: usefulness to ISPE readers; how the articles improve the knowledge of key topics; and clarity/ease of reading.
About the 2017 Article of the Year
For 2017, a panel of judges was assembled, comprising two Board members, the Knowledge Network Council Chair, Pharmaceutical Engineering® Committee Chair, Guidance Documents Committee Chair, one PEC member, two Young Professionals, and two senior ISPE staff members.
To be considered, each article was required to meet the following criteria:
- Cited in other articles or presentations
- Describe or provides industry-leading concept/position/development
- Be well written and referenced
- Demonstrate a progressive and productive approach for the industry
After reviewing all articles published in 2017, the judges chose a unanimous winner:
A Holistic Approach to Production Control: From Industry 4.0 to Pharma 4.0
By: Prof. Dr. Christoph Herwig, Christian Wölbeling, and Thomas Zimmer, PhD
The current submission-based control strategy plays a key role in ensuring that critical quality attributes are met, and the quality target product profile is realized. It does not, however, consider GMP, facilities, utilities, equipment and other production-specific controls to mitigate risk and ensure an effective, reliable, and stable production process. In addition, the effect of unknown process parameters, raw material attributes, and impurities usually are not sufficiently addressed in the control strategy lifecycle management—it is often impossible to predict such variations for a production lifecycle already in development
The ISPE Pharma 4.0 SIG team is proud to receive this award. This article is a great collaborative work, with contributions from SIG members; it reflects the start of a practical road map for applying digitalization and Industry 4.0 in the pharmaceutical industry. We look forward to developing the "holistic control strategy" concept, based on ICH standards, to bring digital maturity and data integrity by design into the pharmaceutical value network and enable flexible pharmaceutical manufacturing.
2017 Article of the Year Award Authors
Previous Article of the Year Award Winners and Finalists
2016:
- "WINNER:" Balancing Pre- and Post-Market Control of Health Supplements
By: Chan Lai Wah, Benjamin Tan Zhi Yang, Vimal Sachdeva, and Sia Chong Hock - Biopharmaceutical Manufacturing Process Validation and Quality Risk Management
By: Francisco C. Castillo, Brendan Cooney, and Howard L. Levine - Cleaning Buffer Preparation Tank Air–Liquid Interface Rings
By: Paul Lopolito, Dijana Hadziselimovic, Amanda Deal, and Amy Thanavaro - Quality Risk Management for Legacy Products in CMOs
By: Humberto Vega and Ricardo Rivera - Current Challenges in Implementing Quality Risk Management
By: James Vesper and Keven O’Donnel
2015:
- "WINNER:" Risk Analysis and Annual Training Program Definition
By: Luca Falce - A Framework for Implementing Stage 3 Continued Process Verification for Legacy Products
By: Bikash Chatterjee and Wai Wong - A Review of the Regulations and International Developments on Quality and Supply Chain Integrity of Pharmaceutical Excipientsn
By: Sia Chong Hock, Sean Lee Ji Yang, Vimal Sachdeva, and Chan Lai Wah - The FDA Observation Response: Seven Common Mistakes
By: Carol Brandt - Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework (Part 1 of 2)
By: Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore and Evdokia Korakianiti - Content Uniformity Discussions: Current USP Developments Regarding and a Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity
By: James Bergum, William Brown, Jon Clark, Thomas Parks, Thomas Garcia, James Prescott, Charles Hoiberg, Sami Patel, and Ravindra Tejwani
2014:
- "WINNER:" Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination
By: Nissan Cohen and Shlomo Sackstein - A Review of Regulations and Developments in GMP and Supply Chain Integrity of Active Pharmaceutical Ingredients
By: Sia Chong Hock, Katherine Loh Kai Xin, Vimal Sachdeva, and Chan Lai Wah - A Steam Sterilization Principles
By: Marcel Dion and Wayne Parker - Evaluation of Controlled Manufacturing Environments following an Air Handling Unit Shutdown
By: Catherine E. Anderson and Brian J. Lloyd, PhD - Applying a Consistent, Compliant, and Practical Risk-Based Validation Process for Laboratory Systems
By: Anil K. Rattan, PhD and Michael Rubacha - A Changing Landscape: Perspectives on Temperature Management for the Distribution of Non-Refrigerated Clinical Supplies Description
By: Dr. Nicole Assfalg, Ted Bradley, Tim Brewer, Sébastien Delporte, Kristen DeVito, Bruce Guenter, and Patricia Thomas