young til from hpv+ tumors
appendix 3 interleukin-2 toxicities observed

Patient: Date of preparation of final product: Unique TIL identifier (tumor and culture number):  
| Tests performed on final product:  Test Method                                                                                                                                                                                        | Limits                          | Result                                 | Initials/Date   |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------|-----------------|
| Cell viability1                                                                                                                                                                                                                       | trypan blue exclusion           | >70% between 109 and                   |                 |
| Total viable cell                                                                                                                                                                                                                     | visual microscopic              |                                        |                 |
| number1                                                                                                                                                                                                                               | count                           | 2 X 1011                               |                 |
| Identity                                                                                                                                                                                                                              | FACs                            | > 80 % CD3+ on REP  cells              |                 |
| TIL potency2                                                                                                                                                                                                                          | OKT3-stimulated IFN             | >200 pg/ml per 105                     |                 |
| release                                                                                                                                                                                                                               | cells and > 2 times  background |                                        |                 |
| Microbiological                                                                                                                                                                                                                       | aerobic culture5                | no growth                              |                 |
| studies                                                                                                                                                                                                                               | anaerobic culture5              | no growth                              |                 |
| gram stain1,3                                                                                                                                                                                                                         | no micro-organisms  seen        |                                        |                 |
| aerobic culture3,4                                                                                                                                                                                                                    | no growth                       |                                        |                 |
| fungal culture3,4                                                                                                                                                                                                                     | no growth                       |                                        |                 |
| anaerobic culture3,4                                                                                                                                                                                                                  | no growth                       |                                        |                 |
| mycoplasma test2                                                                                                                                                                                                                      | negative                        |                                        |                 |
| Endotoxin1                                                                                                                                                                                                                            | limulus assay                   | #5 E.U./kg                             |                 |
| Presence of                                                                                                                                                                                                                           | Cytopathology                   | No tumor cells per  200 cells examined |                 |
| 1 Performed on the final product prior to infusion. Results are available at the time of infusion. tumor cells2  2 Performed 2 - 10 days prior to infusion (test performed prior to final manipulation). Results are available at the |                                 |                                        |                 |  
anaerobic culture5 no growth  
gram stain1,3 no micro-organisms  
seen  
aerobic culture3,4 no growth  
fungal culture3,4 no growth  
anaerobic culture3,4 no growth  
mycoplasma test2 negative  
Endotoxin1 limulus assay #5 E.U./kg  
Presence of  
tumor cells2  
Cytopathology No tumor cells per  
200 cells examined 1 Performed on the final product prior to infusion. Results are available at the time of infusion.  
2 Performed 2 - 10 days prior to infusion (test performed prior to final manipulation). Results are available at the  
time of infusion.  
3 Performed 2-4 days prior to infusion. Results are available at the time of infusion but may not be definitive. 4 Sample for test collected on the final product prior to infusion. Results will not be available before cells are  
infused into the patient.  
5 Sample for test collected on the in process cells prior to the REP. Results will be available before cells are infused  
into the patient.  
Prepared by: _________________________________________ Date: ____________________  
QC sign-off: __________________________________________ Date: ____________________