Table. 1.

Quality assurance of tisagenlecleucel

Appearance and descriptionImpurities
 ColorDetermination of residual beds by microscopy
Identity Percentage of viable CD19+ B cells
 Identity by CAR qPCRQuantity
Safety Total cell count
 Bacterial endotoxins Number of viable cells (calculated)
 Sterility Dose (calculated)
 MycoplasmaPotency
 Determination of VSV-G DNA by qPCR Determination of CAR expression by flow cytometry
Purity Release of IFN-γ in response to CD19- expressing target cells
 Percentage of viable T cells
 Determination of transduction efficiency by CAR qPCR
 Cell viability

Abbreviations: CAR, chimeric antigen receptor; IFN, interferon; qPCR, quantitative polymerase chain reaction; VSV-G, vesicular stomatitis virus-G.

J Korean Soc Transplant 2017;31:157~169 https://doi.org/10.4285/jkstn.2017.31.4.157
© Korean Journal of Transplantation