2026-09-19T14:47:45Zhttps://dspace.mit.edu/server/oai/requestoai:dspace.mit.edu:1721.1/1556172024-07-11T03:12:36Zcom_1721.1_7582com_1721.1_7581col_1721.1_131023
Rubin, Joan
Latouche, Eduardo Luis
System Design and Management Program.
2024-07-10T20:19:40Z
2024-07-10T20:19:40Z
2024-05
2024-06-11T19:51:22.825Z
https://hdl.handle.net/1721.1/155617
https://orcid.org/0000-0002-1825-6712
Cellular and gene therapies have ushered in a new era of medical treatment, promising cures previously thought unattainable. Technologies like CRISPR/Cas9 enable precise genome manipulation, yet challenges persist in therapy delivery, prompting the rise of ex vivo approaches. Despite the promise of adaptive cell therapies, high development costs, manufacturing complexities, and regulatory hurdles hinder widespread adoption. The lack of agreement in the field with respect to centralized versus decentralized manufacturing models and the choice between autologous and allogeneic cell sources pose additional challenges. Equally as critical for global access to these therapies, personnel shortages and specialized expertise requirements must be addressed. A systems engineering approach offers a framework for overcoming these barriers, facilitating comprehensive bioprocess design analysis. Ultimately, developing a descriptive model for analyzing therapeutic delivery is crucial for ensuring equitable access to these transformative therapies worldwide.
S.M.
Massachusetts Institute of Technology
In Copyright - Educational Use Permitted
Copyright retained by author(s)
https://rightsstatements.org/page/InC-EDU/1.0/
Overcoming Challenges in Cellular Therapies: A Systems Engineering Approach for Equitable Access
Thesis
application/pdf
Master
Master of Science in Engineering and Management
Publication
unknown
unknown
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<Abstract>Cellular and gene therapies have ushered in a new era of medical treatment, promising cures previously thought unattainable. Technologies like CRISPR/Cas9 enable precise genome manipulation, yet challenges persist in therapy delivery, prompting the rise of ex vivo approaches. Despite the promise of adaptive cell therapies, high development costs, manufacturing complexities, and regulatory hurdles hinder widespread adoption. The lack of agreement in the field with respect to centralized versus decentralized manufacturing models and the choice between autologous and allogeneic cell sources pose additional challenges. Equally as critical for global access to these therapies, personnel shortages and specialized expertise requirements must be addressed. A systems engineering approach offers a framework for overcoming these barriers, facilitating comprehensive bioprocess design analysis. Ultimately, developing a descriptive model for analyzing therapeutic delivery is crucial for ensuring equitable access to these transformative therapies worldwide.</Abstract>
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