CAR-T cells (Chimeric Antigen Receptor T cells) are a type of personalized immunotherapy designed to treat certain cancers by reprogramming the patient’s own immune cells (or healthy patient) to recognize and destroy cancer cells. CAR-T cell therapies are primarily used to treat hematologic malignancies such as Lymphoma, Acute Lymphoblastic Leukemia (ALL) and Multiple Myeloma.
The fact that CAR-T cell therapies consist of live cells, manufactured from T cells derived from the individual patient, introduces major challenges in process development, manufacturing, logistics, quality control and from a regulatory perspective.
The importance of quality control
Quality control (QC) is essential to ensure the safety and consistency of all medicinal products. For cell therapies, their complexity and personalized nature demand especially rigorous testing to confirm identity, purity, potency, safety, and stability for each individual batch.
However, due to the small batch volumes typically produced, the extensive QC testing requirements can significantly impact the amount of product available for the patient. This contrasts with conventional therapies produced in large volumes and makes QC in cell therapy both critical and uniquely challenging.
Marielle contributed to the writing of this white paper, which explores the practical aspects of quality control in CAR T-cell therapy production, offering insights and recommendations based on real-world experience. By understanding and implementing effective QC strategies, developers and manufacturers can improve the efficiency, reliability, and scalability of their cell therapy products.
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