Environmental monitoring of current good manufacturing practices cleanroom facilities for manufacturing of cellular therapy products in an academic hospital setting

Jay Tanna, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA.
Chase D. McCann, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA; Department of Pediatrics, School of Medicine and Health Sciences, The George Washington University, Washington, District of Columbia, USA.
Rhonda Smith, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA.
Adriana Pitino, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA.
Almaz Asgedom, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA.
Srey Leap Kong, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA.
You Lian Weiner, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA.
Kathryn Bushnell, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA.
Jennifer Webb, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA; Department of Pediatrics, School of Medicine and Health Sciences, The George Washington University, Washington, District of Columbia, USA.
Patrick J. Hanley, Center for Cancer and Immunology Research, Children's National Hospital, Washington, District of Columbia, USA; Department of Pediatrics, School of Medicine and Health Sciences, The George Washington University, Washington, District of Columbia, USA. Electronic address: phanley@childrensnational.org.

Document Type

Journal Article

Publication Date

6-12-2024

Journal

Cytotherapy

DOI

10.1016/j.jcyt.2024.06.008

Keywords

GMP; cell therapy; cleanroom; environmental monitoring; manufacturing

Abstract

As the field of cell and gene therapy (CGT) continues to grow, so too must the infrastructure and regulatory guidance supporting the manufacture of these potentially life-saving products-especially early-phase products manufactured at an increasing number of academic or hospital-based facilities providing decentralized (or point of care) manufacturing. An important component of current good manufacturing practices, including those regulating cell and gene therapies, is the establishment of an effective environmental monitoring (EM) program. While several guidelines for establishing an EM program are available, these guidelines do not specifically address the unique aspects of manufacturing CGT products and they do not provide real-world evidence demonstrating the effectiveness of the program. Here, we describe the establishment and evolution of an EM program in a cell therapy manufacturing facility at an academic hospital. With 10 years of EM data, we analyze the effectiveness for identifying trends in environmental conditions and highlight important findings, with the aim of providing practical evidence and guidance for the development of future early-phase EM programs.

Department

Pediatrics

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