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EU24CEMAR1/SES108 - How to Approach the Deliverable of Flexibility Demanded

‐ Mar 13, 2024 11:15am

Over the past few years after the Covid pandemic, the manufacturing of Cell and Gene Therapeutics (CGT) has been a subject of discussion among various organizations. Although both CGT therapies have been in existence for several years, the key focus now lies in their advantages and widespread acceptance at a manufacturing scale. This is crucial to ensure that these technologies can be made accessible to a larger population. The flexibility of the industries involved will play a vital role in meeting the growing demand for these therapies.
One notable advancement in this field is Chimeric Antigen Receptor (CAR)-T cell therapy. This innovative approach involves modifying a patient's own T-cells to express a receptor that identifies malignant cell structures, leading to the stimulation of the T-cells to attack the cancerous cells. Currently, there are four registered vectors in the US and EU that facilitate the transfer of these cells into the body, with more in various stages of clinical development. Among these approaches, the allogeneic method is most preferred at present, but both autologous and allogeneic methods have promising potential for the future. However, to upscale these technologies and applications, it is imperative to ensure flexibility in the manufacturing process design.