14. 1 The performance of the CELLector™ CD8 and CD4 Cell Culture Flasks will be 
evaluated for purity of the respective TIL using monoclonal antibodies and two 
color flow-cytometry. 
14.2 The expanded CD8( + ) TIL will be evaluated for cell yield, log expansion, and 
cell viability 
14.3 The expanded CD8(+) TIL will be evaluated for cytotoxicity (K562, Daudi, 
Autologous tumor, and allogenic tumor). 
14.4 Assessment of the TIL cells for microbial contamination will be completed 
immediately after the removal of the cells from the CELLector™ Flasks, forty- 
eight (48) hours prior to the preparation of the cells for infusion, and immediately 
after the cells are resuspended in Human Serum Albumin (prior to the cell 
infusion). Microbial contamination will be assessed by aerobic and anaerobic 
cultures, Gram stain, and Mycoplasma testing. 
15. RETROVIRAL TRANSDUCTION AND EXPERIMENTAL STUDIES 
15.1 LNL6 (neoR) VECTOR 
This well characterized vector is being used in a number of approved human 
subject trials. The LNL6 vector is derived from the Maloney murine leukemia 
virus (MMLV) and contains of the 5’ and 3’ terminal repeats, an extended (j> 
sequence including a portion of the 5’ reading frame of the retroviral gag 
proteins. The neoR gene is driven by the promoter in the 5’ LTR. 
This vector was transfected into the PA317 cell line which produces virus-rich 
supernatants and has been demonstrated to be free of wild type (infectious) viruses 
and has passed FDA-required safety tests. 
The LNL6 vector will be provided as frozen supernatant stocks at no cost by 
Genetic Therapy, Incorporated, Gaithersburg, MD. 
15.2 GIN (neoR) vector 
This neoR vector was developed by GTI and is virtually identical to LNL6. At 
position 1470 there are 16 additional bp derived from the pGl polylinker. At 
position 2336 in GIN, 680bp of 3 1 untranslated neoR gene sequences are deleted 
and 36 bp derived from pGl poly linker added. 
Recombinant DNA Research, Volume 15 
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