untitled h1
appendix 5

Certificate of Analysis Infused T cells transduced with anti-MAGE-A3 HLA-A*01-restricted TCR
Date of preparation of final product: Patient: Tests performed on final product:  
| Test                                                                                                | Method                          | Limits                                | Result   | Test  Performe d by   | Initials/ Date   |
|-----------------------------------------------------------------------------------------------------|---------------------------------|---------------------------------------|----------|-----------------------|------------------|
| Cell viability1                                                                                     | trypan blue exclusion           | >70%                                  |          |                       |                  |
| Total viable cell                                                                                   | visual microscopic              | >1 x107                               |          |                       |                  |
| number1                                                                                             | count                           |                                       |          |                       |                  |
| Tumor                                                                                               | -IFN release vs.               |                                       |          |                       |                  |
| reactivity2                                                                                         | peptide pulsed A1+  cells       | >200 pg/ml, and >  2 times background |          |                       |                  |
| TCR                                                                                                 | FACS analysis of the            | PBL, >10%                             |          |                       |                  |
| Expression2                                                                                         | transduced cells gram stain1,3, | no micro-organisms                    |          |                       |                  |
| Microbiological  studies                                                                            | seen                            |                                       |          |                       |                  |
| aerobic culture3,4                                                                                  | no growth                       |                                       |          |                       |                  |
| fungal culture3,4                                                                                   | no growth                       |                                       |          |                       |                  |
| anaerobic culture3,4                                                                                | no growth                       |                                       |          |                       |                  |
| mycoplasma test5                                                                                    | negative                        |                                       |          |                       |                  |
| Endotoxin                                                                                           | limulus assay1                  | <5 E.U./kg                            |          |                       |                  |
| RCR                                                                                                 | S+L- Assay4                     | negative                              |          |                       |                  |
| RCR-PCR6                                                                                            |                                 |                                       |          |                       |                  |
| 1  Performed on sample of the final product immediately prior to infusion. Results are available at |                                 |                                       |          |                       |                  |  
1 Performed on sample of the final product immediately prior to infusion. Results are available at the time of infusion.  
2 Performed 2-10 post transduction. 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 collected from the final product prior to infusion. Results will not be available before cells are infused into the patient.  
5 Performed 2-10 days prior to infusion. Results are available at the time of infusion.  
6 Performed on sample approximately 1-4 days prior to infusion. Results are available at the time of infusion.  
Prepared by: _______________________________________ Date: ____________________  
QC sign-off: _______________________________________ Date: ____________________
Qualified Clinical or Laboratory Supervisor