OCTOBER 20258CANADAIN MY OPINIONMAKING CELL THERAPYACCESSIBLE TO ALL PATIENTSell and gene therapies (CGTs) have been rapidly growing in recent years due to successful clinical results. As of Q4 2022, globally, 104 CGTs received full approval (excluding RNA therapy), 13 more are anticipated in the US and EU by the end of 2023 and more than 2,000 are currently in clinical trials. One of the fastest growing segments utilizes T cells; specifically, the use of chimeric antigen receptor (CAR) T cell immunotherapy for hematological malignancies.Significant investment and innovation are happening in CGTs, with several novel treatment options being developed and six CAR T cell products achieving FDA approval since 2017.Despite the positive outcomes for patients, widespread adoption of CGTs remains limited, with cost and scalability being the primary concerns. The list price of approved CAR T cell therapies ranges from $373,000 to $475,000. The manufacturing methods adopted during clinical trials often do not translate to efficient commercial-scale manufacturing. The cost and scalability challenges can be partially attributed to the fact that personalized medicine cannot utilize conventional manufacturing methods, which are based on producing large batches for mass distribution. ChallengesLabor, materials, overhead and shipping are the primary challenges with cost and scalability.The manufacturing of CAR T cell products is very labor-intensive. A typical manufacturing run spans ten days, with multiple manual interventions and various quality control checks required. A dedicated team of three people working the equivalent of five days per product means approximately fifteen full-time equivalent days is required per product. Not only is this expensive, but it is challenging to recruit and train qualified personnel for these complex manufacturing methods.CBy Nuala Trainor, Director of Innovation, LonzaNuala Trainor
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