The article focuses on the unique needs and considerations for cell and gene therapy (C>) manufacturing suites and how they differ from those for classic product bio-pharmaceuticals.
The article wins the 2022 Article of the Year award because the authors describe the processes and supply challenges, the GMP’s requirements, and the biosafety precautions that major companies, contract development and manufacturing organizations (CDMOs), and start-ups should consider before building multipurpose, flexible manufacturing facilities to produce successful new allogeneic and autologous treatment platforms. The article is very useful for each C> professional and stakeholder in development and manufacturing,
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: recognition of quality and excellence in content by identifying final-ists and a single winning article for each publication year.
2022 Judging
A subcommittee of the PEC served as judges for the 2022 award competition, reviewing articles and providing assessments on the following criteria: usefulness to ISPE readers; how the articles improve the knowledge of key topics; and clarity and ease of reading.
2022 Award Finalist
The other articles selected as finalists for the 2022 Roger F. Sherwood Article of the Year were:
“Introduction to Steam Quality and Testing” (July/August 2022) By Nissan Cohen, Nicholas Haycocks, Jeremy Miller, FIET, FinstR, Derek Mullins, and Keith Shuttleworth
Share Your Knowledge
Submit an article on Facilities Conversion to PE Magazine.
PE Magazine is looking for submissions focused on converting existing manufacturing plants and processes to improve efficiency and reliability, ensuring the timely delivery of quality and compliant products to patients. Topics include:
Digital innovation via automation, implementation of Pharma 4.0 principles, and artificial Intelligence
Transformation of aging facilities (brownfield versus greenfield, bluefield)
Conversion to continuous manufacturing
Adoption of single-use technology from a sustainability perspective
Facilities Conversion is the editorial theme for the July/August 2024 issue of PE magazine. Deadline for submission is 1 Mar 2024.
ISPE delivers technical and operational solutions to support across the global pharmaceutical and biopharmaceutical industry in the manufacture of quality medicines for patients.
Lorrie Vuolo-Schuessler has been involved with ISPE and GAMP® projects since 2002. She has authored or co-led 11 ISPE GAMP-focused guidance documents, including ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and the ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is Immediate Past Chair of...
An ISPE member since 1999, Charlie Wakeham has been active within the ISPE GAMP® community since 2001. A founding member of the GAMP UK Community of Practice (CoP), she is currently Chair of the GAMP Global CoP Steering Committee, one of the leaders of the GAMP Computer Software Assurance Special Interest Group (SIG), and a member of the ISPE Guidance Documents Committee. She has co-led or...
The new ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction materials and updates on current good practices. It was revised based on the latest International Organization for Standardization in Pharmaceuticals, American Society for Testing and Materials, and American Society of Mechanical Engineers standards and is aligned with the latest regulatory...