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For cell and gene therapies to reach their full potential, changes in manufacturing must be explored.
The field of cell and gene therapy has delivered personalized and, in some cases, curative therapeutics for various conditions including cancer and monogenetic disorders. Cell and gene therapies have been studied in various forms for decades, primarily in academia, and in recent years have gained traction in treating real-world conditions. The tide began to change in cell therapy about a decade ago with the treatment of the first patients with CTL-019, the first chimeric antigen receptor T cells (CAR-T) approved by FDA, now known as Kymriah, at the University of Pennsylvania to treat acute lymphoblastic leukemia (ALL). And in gene therapy, Zolgensma took center stage for its ability to provide children with certain forms of spinal muscular atrophy (SMA), many times lethal by age four, a potentially curative treatment.
As the pace of commercial approvals begins to gain steam, there are key questions about how to efficiently develop and, potentially more importantly, manufacture these therapeutics at a cost that balances revenue with affordability. It’s well known that cell and gene therapies are driving massive innovation in medicine. According to a report, the market for cell and gene therapies is expected to reach more than $36 billion by 2027, driven by the increasing number of clinical and commercial cellular and gene therapy products.
Read this article in BioPharm International’s Emerging Therapies 2022 eBook.
Matt Hewitt is executive director, Scientific Services Cell and Gene Therapy at Charles River.
BioPharm International
eBook: Emerging Therapies, September 2022
Pages: 18–20
When referring to this article, please cite it as M. Hewitt, “The Road to Personalized Medicine: Reimagining Drug Manufacturing,” BioPharm International Emerging Therapies eBook (September 2022).