. Author manuscript; available in PMC: 2020 Mar 1.

Published in final edited form as: Cytotherapy. 2018 Dec 1;21(3):307–314. doi: 10.1016/j.jcyt.2018.11.004

Table 1.

In-Process and Lot Release Testing for TIL

	Test	Method	Acceptable Results
In-Process Testing (Pre-REP)	Sterility	Aerobic, Anaerobic culture (BACT/ALERT®) Fungal culture	No growth
	Tumor-specific T cell activation	IFN-γ ELISA	>200 pg/ml
	Viability	Cellometer AO/PI or Manual Trypan Blue	>70% viable cells
	Cell Count	Cellometer AO/PI or Manual Trypan Blue	>60 × 10⁶ cells
Lot Release Testing (Post-REP)	Mycoplasma contamination	PCR (VenorGeM) or qPCR (MycoTOOL)	Negative
	Sterility^*	Aerobic, Anaerobic culture (BacT/ALERT®) Fungal culture	No growth
	Gross Contamination	Gram stain	No organisms seen
	Purity	Endosafe®	<5 EU/kg
	Identity	Flow cytometry	>90% CD45+ CD3+ cells
	Viability	Cellometer AO/PI or Manual Trypan Blue	>70% viable cells
	Cell Count	Cellometer AO/PI or Manual Trypan Blue	0.1 – 2 × 10¹¹ cells
	Tumor-specific T cell activation	IFN-γ ELISA	>200 pg/ml

Sterility test results are not available prior to release of the final product.