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

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.