The article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.
“The article provides industry professionals and management, as well as the public, the evidence that it is possible and it is accepted by major regulatory authorities to eliminate or significantly reduce the usage of animals for in vivo testing,” said Ferdinando E. Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharmaceutical Engineering Committee (PEC).
“In vivo assay, cell bank stability and purity, and pyrogen tests are carried out to ensure and confirm the safety, purity, and potency of the manufacturing processes and of the biopharmaceutical finished products,” he continued. “The article fosters the industry-wide implementation of the 3R concept and, above all, of in vitro testing. This approach has the potential of saving millions of rabbits, mice, and endangered species like the horseshoe crabs yearly, and it shows the industry commitment to the Sustainability principles.”
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.
2024 Judging
A subcommittee of the PEC served as judges for the 2024 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 provides industry professionals and management, as well as the public, the evidence that it is possible and it is accepted by major regulatory authorities to eliminate or significantly reduce the usage of animals for in vivo testing.
2024 Award Finalists
Finalists for the 2024 Roger F. Sherwood Article of the Year included the following:
- “Quality Considerations in Disaster Recovery: A Case Study,” by Frank Henrichmann, Oliver Herrmann, Maximilian Stroebe, PhD, and Marcus Schwabedis-sen
- “Building Better Therapies with Antibody Engineering,” by Amit S. Choudhari, PhD, and Vikal Tripathy, PhD
- “Room Differential Pressures in Facility Design: Fundamentals,” by Norman Goldschmidt, Nicholas R. Haycocks, and Ulla Thomsen
- “FDA’s 2011 Process Validation Guidance: 10 Years On,” by ISPE Process Validation Team
- “Finding the Assurance in Computer Software Assurance,” by Charlie Wakeham, Lorrie Vuolo-Schuessler, and Siôn Wyn
- “Industry Perspectives on Practical Application of Platform Analytical Procedures,” by Timothy W. Graul, PhD, Nina S. Cauchon, PhD, Frank Bernardoni, Bryan C. Castle, PhD, Christof Finkler, PhD, Suminda Hapuarachchi, PhD, John Harrahy, PhD, Daniel Hemminghaus, Elisabeth Krug, PhD, Sachin Lohani, PhD, Amir Malek, He Meng, Hetalben Patel, PhD, Mary Beth Pelletier, PhD, Karen Rule, and Jason Starkey
- “Potency Measurements for Cellular and Gene Therapy Products,” by Maria Amaya, PhD, Andrew Chang, PhD, Keith Wonnacott, PhD, Derek T. Scholes, PhD, John MacNair, PhD, Lawrence C. Starke, PhD, and Lesbeth C. Rodriguez
- “Single-Use Technology Waste in Manufacturing Operations,” by Cristina Van Loy, PhD, Pietro Perrone, PhD, PE, Adam Goldstein, Andrew Sinclair, Eric Langer, Treasa Rohrer, Katell Mignot, and Javier Lozano
