“The article wins the 2023 Article of the Year Award because it thoroughly describes the challenges the industry faces to scale up or out the manufacturing process of complex products like cell and gene therapies, as well as any risk assessment that needs to be done when faced with a change in the manufacturing process or in the materials used. The article is very useful for cell and gene therapy professionals and stakeholders in development and manufacturing,” said Ferdinando E. 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. Three decades later, the award showcases the best content in Pharmaceutical Engineering®, increases industry recognition, highlights ISPE’s reputation as a global knowledge leader, and bolsters magazine content quality.
Although various judges have taken part in assessing articles over the years, one constant remains: the award recognizes quality and excellence in content by identifying finalists and a single winning article for each publication year.
2023 Judging
A subcommittee of the PEC served as judges for the 2023 award competition, reviewing articles and providing assessments on the following criteria:
- Usefulness to ISPE readers
- How the articles improve knowledge of key topics
- Clarity and ease of reading
The article is very useful for cell and gene therapy professionals and stakeholders in development and manufacturing.
2023 Award Finalists
The other articles selected as finalists for the 2023 Roger F. Sherwood Article of the Year were:
- “A Proposal for A Comprehensive Quality Overall Summary” (May/June) by Roger Nosal, Connie Langer, Beth Kendsersky, Jennifer L. Brown, Megan E. McMahon, and Timothy J.N. Watson, PhD
- “Agile Data-Driven Life Cycle Management for Continuous Manufacturing” (July/August) by Rui C. Silva, PhD, Rui Almeida, Pedro Ferreira, José Cardoso Menezes, PhD, and Angela Martinho
- “An Evaluation of Postapproval CMC Change Timelines” (September/October) by Rob Harris, PhD, Meike Vanhooren, Kara Follmann, PhD, Beth Kendsersky, Timothy J.N. Watson, PhD, Melinda Imperati, S. Connor Dennis, PhD, and Roger Nosal
- “New EU AI Regulation and GAMP® 5” (September/October) by Anders Vidstrup
- “Delivering Curative Therapies – Autologous vs Allogeneic Supply Chains” (November/December) By Pinar Cicalese, PhD and Niranjan S. Kulkarni, PhD
- “Design Considerations for Large-Scale Stem Cell Manufacturing” (November/December) by Daniel L. Swanson, BSChE, MBA, PE and Christian Estes, PE
- “Environmental Sustainability in Biopharmaceutical Facility Design” (Online Exclusive) by William G. Whitford, Emily Heffernan, PE, and Aoife Kelly
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