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ABSTRACT
Introduction
The inception of recombinant DNA technology and live cell genomic alteration have paved the path for the excellence of cell and gene therapies and often provided the first curative treatment for many indications. The approval of the first Chimeric Antigen Receptor (CAR) T-cell therapy was one of the breakthrough innovations that became the headline in 2017. Currently, the therapy is primarily restricted to a few nations, and the market is growing at a CAGR (current annual growth rate) of 11.6% (2022–2032), as opposed to the established bio-therapeutic market at a CAGR of 15.9% (2023–2030). The limited technology democratization is attributed to its autologous nature, lack of awareness, therapy inclusion criteria, high infrastructure cost, trained personnel, complex manufacturing processes, regulatory challenges, recurrence of the disease, and long-term follow-ups.
Areas covered
This review discusses the vision and strategies focusing on the CAR T-cell therapy democratization with mitigation plans. Further, it also covers the strategies to leverage the mRNA-based CAR T platform for building an ecosystem to ensure availability, accessibility, and affordability to the community.
Expert opinion
mRNA-guided CAR T cell therapy is a rapidly growing area wherein a collaborative approach among the stakeholders is needed for its success.
Article highlights
Approved CAR T-cell therapy and its potential are highlighted.
CAR T-cell product quality matrix is described and the focus area for CAR T-cell therapy democratization is advocated.
mRNA-based CAR T-cell therapy potential and limitations are explicitly discussed along mitigation plans.
A detailed differentiation in the manufacturing process for the lentivirus and mRNA production is discussed.
An expert opinion on mRNA-guided CAR T-cell platform democratization is deliberated.
Abbreviations
| CAR | = | Chimeric Antigen Receptor |
| CAGR | = | Current annual growth rate |
| IL-2 | = | Interleukin-2 |
| IL-4 | = | Interleukin-4 |
| TNF-α | = | Tumor necrosis Factor-alpha |
| TNFγ | = | Tumor necrosis factor-gamma |
| IL-12 | = | Interleukin |
| CD | = | Cluster of Differentiation |
| TRUCK | = | T-cell redirected for universal cytokine-mediated killing |
| US-FDA | = | United states of America, Food and Drug Administration |
| CDSCO | = | Central Drugs Standard Control Organisation, Government of India |
| ALL | = | Acute lymphoblastic leukemia |
| DLBCL | = | Diffuse large B-cell lymphoma |
| LV | = | lentiviral |
| NK-cells | = | Natural-killer cells |
| cGMP | = | Current Good Manufacturing Practice |
| MCP-1 | = | Monocyte chemoattractant protein-1 |
| MIP-1B | = | macrophage inflammatory protein-1B |
| GM-CSF | = | Granulocyte-macrophage colony-stimulating factor |
| USD | = | United state Dollar |
| NGOs | = | Non-governmental organization |
| CGT | = | Cell and gene therapy |
Declaration of interest
S Srivastava, S Singh and A Singh are all employed by Gennova Biopharmaceuticals Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.