Advanced Cell Therapy product release containing CAR-T cells

Authors

  • Juliana Preto de Godoy Hospital Israelita Albert Einstein
  • Lucila Nassif Kerbauy Hospital Israelita Albert Einstein
  • Raquel Melo Alves Paiva Hospital Israelita Albert Einstein
  • Andrea Tiemi Kondo Hospital Israelita Albert Einstein
  • Oswaldo Keith Okamoto Universidade de São Paulo
  • José Mauro Kutner Hospital Israelita Albert Einstein

DOI:

https://doi.org/10.46765/2675-374X.2022v3n1p156

Keywords:

CAR-T cells, product release, potency test, sterility, safety

Abstract

Manufacturing of customized gene or cell therapy products  such as CAR-T cells is complex and depends on release tests and exams that can attest to a consistent quality standard for each product. The quality of CAR-T cell products is subject to donor variation, but also includes the manufacturing environment, as well as the quality and availability of materials and reagents. Quality must be carefully monitored and integrated into the manufacturing process.

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Published

04/24/2022

How to Cite

Preto de Godoy, J., Nassif Kerbauy, L., Melo Alves Paiva, R., Tiemi Kondo, A., Keith Okamoto, O., & Mauro Kutner, J. (2022). Advanced Cell Therapy product release containing CAR-T cells. JOURNAL OF BONE MARROW TRANSPLANTATION AND CELLULAR THERAPY, 3(1), 156. https://doi.org/10.46765/2675-374X.2022v3n1p156

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