From classroom to cleanroom: building a skilled cell and gene therapy workforce

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Authors: Ali Shokoohmand, Eddie Han Pin Tan, Arwa Z. Al‐Riyami, Anna Koptina, Colleen Richards, Mariana Morato-Marques, Piriya Yoganathan, Nouf Al-Rasheed, Gemma Moir-Meyer, Nikita Mayur Patel, Alicia Didsbury, Jennifer L. Quizi
+9 more Michael J. Medlyn, Timothy D. Wiltshire, Dominic Fernandez, Laura Garcia-Gerique, Janet MacPherson, Rachel A. Burga, Matthew Hewitt, Patrick J. Hanley, Z. Velickovic
Cited by: 1
References: 31

Abstract

The demand for the CGT workforce exceeds the capacity of current training programs to produce professionals ready for Good Manufacturing Practice (GMP) operations and associated quality and regulatory requirements. Most academic programs build strong scientific foundations but do not consistently prepare learners for process development and disciplined practice within regulated quality systems, resulting in prolonged onboarding and variable early performance. This gap reflects not only the specialized operational demands of CGT, but also the fact that most universities are designed to provide broad scientific education rather than role-specific preparation for a single employment sector. We synthesized a literature- and stakeholder-informed CGT Education Framework comprising five mutually reinforcing pillars: (i) curriculum innovation that embeds quality and GMP principles, (ii) interdisciplinary integration across science, engineering, and regulation, (iii) inclusive and scalable delivery approaches, (iv) structured experiential learning in GMP-aligned settings, and (v) competency-based credentialing. An accompanying implementation roadmap defines role-specific actions, timelines, and measurable workforce readiness outcomes, while case studies and short-format training exemplars illustrate practical application. Together, these recommendations provide a pathway to align academic preparation with the technical, regulatory, and quality-compliance demands of CGT, improve time-to-productivity, and support global workforce mobility. They move the field from ad hoc initiatives to a coherent, outcomes-driven approach that builds a pipeline of resilient, industry-ready talent.

Fields of Study & Subjects

CAR-T cell therapy research Biomedical Ethics and Regulation Biomedical and Engineering Education

Publication details

Journal / source
Cytotherapy
Publisher
Elsevier BV
Volume
28
Issue
11
Pages
102899–102899
Publication date
26 April 2026
Language
EN