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. 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 through identifying finalists and a single winning article for each publication year.

2023 Article of the Year

Winner of the 2023 Article of the Year Award

The 2023 Roger F. Sherwood Article of the Year is “Comparability Considerations for Cellular and Gene Therapy Products” (November/December) by Kathleen Francissen, PhD, Andrew Chang, PhD, Katherine A. Donigan, PhD, Emily C. Hernández, PhD, and Sam Gunter, MPP

The article focuses on points to consider when evaluating the comparability of Cell and Gene Therapy when changes are made in their manufacturing processes.

The article wins the 2023 Article of the Year Award because it thoroughly describes the challenges that 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.

Ferdinando Aspesi

Senior Partner

Bridge Associates International -FEA

Award Finalists

• “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
• Winner: “Comparability Considerations for Cellular and Gene Therapy Products” (November/December) by Kathleen Francissen, PhD, Andrew Chang, PhD, Katherine A. Donigan, PhD, Emily C. Hernández, PhD, and Sam Gunter
• “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

Judging

A subcommittee of the Pharmaceutical Engineering Committee (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 the knowledge of key topics; and clarity/ease of reading.

Finalists for the award were selected by a subcommittee of the Pharmaceutical Engineering Committee (PEC) from 39 feature and technical articles published during calendar year 2023.

Previous Article of the Year Award Winners and Finalists

• About the 2022 Article of the Year

  The 2022 Roger F. Sherwood Article of the Year is “Supporting Cell and Gene Therapy through Multimodal and Flexible Facilities,” (November/December 2022) by Stephen Judd and William G. Whitford.

  The article focuses on the unique needs and considerations for cell and gene therapy (C&GT) manufacturing suites and how they differ from those for classic product biopharmaceuticals.

  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, CDMOs, and startups should consider before building multipurpose, flexible manufacturing facilities to produce successful new allogenic and autologous treatment platforms. The article is very useful for each C&GT professional and stakeholder in development and manufacturing,” said Ferdinando Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharmaceutical Engineering Committee (PEC).

  AWARD FINALISTS

  • Winner: “Supporting Cell and Gene Therapy through Multimodal and Flexible Facilities,” (November/December 2022)
    by Stephen Judd and William G. Whitford
  • “Measuring Pharma’s Adoption of Industry 4.0” (January/February 2022)
    By Toni Manzano and Agustí Canals, PhD
  • “Driving Biopharma Solutions with Digital Technologies” (January/February 2022)
    By Martin Mayer
  • “A Governance and QA Framework: AI Governance Process Design” (July/August 2022)
    By Elias Altrabsheh, Martin Heitmann, FRM, and Albert Lochbronner
  • “Integrating Knowledge Management and Quality Risk Management” (July/August 2022)
    By Martin J. Lipa, PhD, Valerie Mulholland, and Anne Greene, PhD
  • “Introduction to Steam Quality and Testing” (July/August 2022)
    By Nissan Cohen, Nicholas Haycocks, Jeremy Miller, FIET, FinstR, Derek Mullins, and Keith Shuttleworth

• About the 2021 Article of the Year

  The 2021 Roger F. Sherwood Article of the Year is “Medical Device UDI Components Management in the European Union” (July-August 2021) by Laurence Azoulay, Marie Coulon, PharmD, Christophe Devins, Bernard Durand, Etienne Granier, Amel Guerrida-Marchand, Ye-Lynne Lee, Valérie Marchand, Patrick Mazaud, Brigitte Naftalin, Michel Raschas, and Nadim Wardé.

  The article focuses on the unique device identification (UDI) portion of the European Union’s (EU) Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), which are binding on all EU member states. The general application dates of the two regulations were 26 May 2021 for medical devices and 26 May 2022 for in vitro diagnostic medical devices; however, different timelines apply for certain specific provisions.

  AWARD FINALISTS

  • Winner: “Medical Device UDI Components Management in the European Union” (July-August 2021)
    By Laurence Azoulay, Marie Coulon, Christophe Devins, Bernard Durand, Etienne Granier, Amel Guerrida Marchand, Ye-Lynne Lee, Valerie Marchand, Patrick Mazaud, Brigitte Naftalin, Michel Raschas, and Nadim Wardé
  • “ICH Quality Guidelines: Present Initiatives and ISPE Involvement” (September-October 2021)
    By Nina S. Cauchon, Christine M. V. Moore, and Christopher J. Potter
  • “Cloud Computing Implications for Manufacturing Execution Systems” (May-June 2021)
    By Paul J. Irving, Gregory M. Ruklic, and Jonathan Hurle
  • “Model-Informed Drug Development Addresses COVID-19 Challenges” (January-February 2021)
    By Patrick Smith and Karen Rowland-Yeo
  • “Material Properties Databases to Advance Pharmaceutical Processing” (March-April 2021)
    By Jamie Clayton
  • “A Beginner’s Guide to IT System Inspection Readiness” (May-June 2021)
    By Anders Vidstrup

• About the 2020 Article of the Year

  The 2020 Roger F. Sherwood Article of the Year is “Implementation of a Formal Energy-Efficient Design Process” (Mar-Apr) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane.

  The article describes a formal energy-efficient design (EED) process that has been in use across all industries in Ireland since 2014 and addresses the benefits of integrating this type of study into the design process. Improving efficiency in a highly regulated environment can be a challenge, but companies in even the most regulated industries in Ireland (e.g., pharmaceutical, biopharmaceutical, and semiconductor manufacturers) are adopting the methodology. The article was derived from the authors’ experiences across many projects and in the development of the Irish standard I.S. 399, which establishes energy-efficient design as a management system (complementing ISO 9001 and ISO 50001). It provides companies with a robust strategy for delivering energy, environmental, quality, and competitiveness objectives.

  • Winner: “Implementation of a Formal Energy-Efficient Design Process” (Mar-Apr)
    By Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane
  • “Evaluation of Visual Inspection in Parenteral Products” (Jan-Feb)
    By Sambhujyoti Das
  • “Chlorine Dioxide Gas Decontamination vs. Liquid Disinfection” (Mar-Apr)
    By Jennifer A. Longstaff
  • “Good Engineering Practice in Risk-Based Commissioning & Qualification” (May-Jun)
    By William Bennett, PMP
  • “ICH Q12: A Transformational Product Life-Cycle Management Guideline” (May-Jun)
    By Eli Zavialov, PhD, Albert V. Thomas, Saroj Ramdas, Terrance Ocheltree, PhD, RPh, and Connie Langer
  • “Quality & Regulatory Solutions for PAT in Continuous Manufacturing” (Sep-Oct)
    By Gabriella Dahlgren, PhD, Kevin A. Macias, Antonio R. Moreira, PhD, Duncan R. Thompson, Christoph Herwig, PhD, Robert Dream, PE, CPIP
  • “Operational Risk Management in Global Supply Scenarios” (Nov-Dec)
    By Klaus Finneiser

• About the 2019 Article of the Year

  The 2019 Roger F. Sherwood Article of the Year is “Regulating Online Pharmacies and Medicinal Product E-Commerce” (Nov-Dec 2019) by Sia Chong Hock, Mervyn Ming Xuan Lee, and Lai Wah Chan. The article explores the growth of e-commerce for prescription and over-the-counter (OTC) medicinal products.

  The 2019 finalists were:

  • Winner: “Regulating Online Pharmacies and Medicinal Product E-Commerce” (Nov-Dec 2019) By Sia Chong Hock, Mervyn Ming Xuan Lee, and Lai Wah Chan
  • “Automated Parts Washer Factory Acceptance Test” (Mar-Apr 2019)
    By Olivier Van Houtte, Paul T. Lopolito, Dijana Hadziselimovic, and Neo Aik Ann
  • “Inline Dilution: An Agile Capability for Downstream Manufacturing” (May-Jun 2019)
    By Lindsey Daniel, PE, and Avril Vermunt
  • “Holistic Control Strategies for Continuous Manufacturing” (May-Jun 2019)
    By Christine M. V. Moore, PhD, Thomas P. Garcia, PhD, Douglas B. Hausner, and Inna Ben-Anat
  • “Accelerated Pharmaceutical Product Development, Registration, Commercialization, and Life Cycle CMC Lessons, Part 1” (Jul-Aug 2019)
    By Christopher J. Potter, PhD, Huimin Yuan, PhD, Nina S. Cauchon, PhD, Liuquan Lucy Chang, Derek Blaettler, Daniel W. Kim, PharmD, Peter G. Millili, PhD, Gregory J. Mazzola, Terrance Ocheltree, PhD, RPh, Stephen M. Tyler, Geraldine Patricia Taber, PhD, and Timothy J. N. Watson, PhD
  • “A New Qualification Approach for Mobile Purified Water Systems” (Jul-Aug 2019)
    By Fritz Röder
  • “Why ISPE GAMP® Supports the FDA CDRH Case for Quality Program” (Nov-Dec 2019)
    By Siôn Wyn, Christopher J. Reid, Chris Clark, Michael L. Rutherford, Heather D. Watson, Lorrie L. Vuolo-Schuessler, and Arthur D. Perez, PhD

• 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:

  • WINNER: Continuous Manufacturing In Biotech Processes: Challenges for Implementation (November-December 2018)
    Robert Dream, CPIP, PE, Christoph Herwig, PhD, and Emilie Pelletier
  • 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

   

• 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

  Read Full Article

  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