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4 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com Assessing the Quality of CAR-T Cells Using ddPCR CAR-T cell therapy development is a complex process that requires standardization. C himeric antigen receptor (CAR)-T cells have already changed how certain cancers are treated. As of February 2022, FDA had approved five CAR-T cell therapies to treat liquid tumors in patients with various types of leukemia and lymphoma (1). The biopharmaceutical industry has invested heavily in the future of this novel treatment modality, and CAR-T cells now account for 56% of cell immunotherapies in development (2). By 2030, one forecast predicts that the CAR-T cell market will grow to $21.7 billion (3). With this growth, however, comes the realization across the industry that CAR-T cell therapy development is a complex process that requires standardization, regulation, and meticulous quality control to reliably generate safe and effective therapies. In addition, when developing CAR-T cells, biomanufacturers can have their choice of cell sources and bioprocesses, which can lead to variability in success as well as openings for inefficiency and waste. Analytical tools such as droplet digital polymerase chain reaction (ddPCR), a technology platform used to quantify nucleic acids, can support CAR-T cell manufacturers in developing successful CAR-T cell products. The importance of quality control in CAR-T cell devel- opment is evident in the development process itself. First, a physician draws blood from a patient and a technician extracts the T cells. Next, a technician delivers the CAR gene to the T cells, typically using viral vectors. The cells take up the gene and express it, generating the CAR protein. This protein, in turn, gets shuttled to the cell surface,` thereby transforming the MARK WHITE AND MARWAN ALSARRAJ Quality and Regulatory Sourcebook Quality: Analytics tilialucida - Stock.adobe.com MARK WHITE, PhD, is the associate direc tor of Biopharma Produc t Marketing, and MARWAN AL SARR A J is the Biopharma Segment manager; both are at Bio-Rad.