OBJECTIVES: The study aims to explore the collaborative strategies between research institutions, healthcare providers, and biopharmaceutical companies to improve patient access to autologous CAR T-cell therapies. Given the laborious, expensive, and time-consuming nature of CAR T-cell therapy manufacturing, this study investigates strategies to overcome current barriers.

METHODS: We conducted a comprehensive review of current manufacturing practices and logistics for CAR T-cell therapies in literature, focusing on centralised versus decentralised models. Interviews with industry experts and stakeholders were performed to identify bottlenecks and potential solutions for streamlining the manufacturing and distribution processes.

RESULTS: Our analysis indicates that decentralised manufacturing, particularly at the point of care using automated and closed-system technologies, offers significant advantages in terms of scalability and flexibility. This approach can reduce the logistical complexities and costs associated with centralised manufacturing, such as continuous control, traceability, as well as omit the cryopreservation and thawing steps that influence product quality. Public-private partnerships emerged as a crucial strategy for leveraging public funding and private sector expertise to drive innovation and expand access to CAR T-cell therapies.

CONCLUSIONS: Balancing cooperation and competition between biopharmaceutical companies, research institutions, and healthcare providers is essential to meet the growing demand for CAR T-cell therapies. Decentralised manufacturing, supported by automated and closed-system technologies, can enhance scalability and maintain product quality, ultimately facilitating broader patient access. Public-private partnerships play a pivotal role in addressing the financial and regulatory challenges, thereby fostering innovation and ensuring the sustainability of CAR T-cell therapies in the healthcare landscape.