Assessing the Quality of CAR-T Cells Using ddPCR

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BioPharm International, BioPharm International, Regulatory Sourcebook March 2022, Volume 2022 eBook, Issue 1
Pages: 4–7

CAR-T cell therapy development is a complex process that requires standardization.

With the growth of chimeric antigen receptor (CAR)-T cell therapies comes the realization across the industry that CAR-T cell therapy development is a complex process requiring standardization, regulation, and meticulous quality control to 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.

Read this article in BioPharm International’s March 2022 Quality and Regulatory Sourcebook eBook.

About the authors

Mark White, PhD, is the associate director of Biopharma Product Marketing, and Marwan Alsarraj is the Biopharma Segment manager; both are at Bio-Rad.

Article Details

BioPharm International
eBook: Quality and Regulatory Sourcebook, March 2022
March 2022
Pages: 4–7

Citation

When referring to this article, please cite it as M. White and M. Alsarraj, “Assessing the Quality of CAR-T Cells Using ddPCR," BioPharm International Quality and Regulatory Sourcebook eBook (March 2022).