Overcoming Challenges in Cellular Therapies: A Systems Engineering Approach for Equitable Access

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.

Name thesis:degree_name

Master

Department dc:contributor.department

System Design and Management Program.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2024

Author dc:creator

• Latouche, Eduardo Luis

Advisor dc:contributor.advisor

• Rubin, Joan

Statement dc:rights

• In Copyright - Educational Use Permitted
• Copyright retained by author(s)

Licence dc:rights.uri

• https://rightsstatements.org/page/InC-EDU/1.0/

Handle dc:identifier.uri

https://hdl.handle.net/1721.1/155617

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/155617