Documentation: a. After the cells have infused, remove the adhesive backed “cell therapyproduct” tag from the cell bag and place it on a progress note. Sign and date the progress note then send it to medical records. b. Document the cell infusion in CRIS using the Surgery Branch Cell Product Administration Flowsheet. Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 56c. Two separate Surgery Branch Cell Product Administration Flowsheets should be completed: one for the IV and a second one for the SQ cell administration. Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 57 APPENDIX 2: C ERTIFICATE OF ANALYSIS FOR IMMATURE DENDRITIC CELLS Personalized Dendritic Vaccine Patient: Date of preparation of final product: Tests performed on final product: Test Method Limits Result Tests Performed byInitials/Date Cell viability1trypan blue exclusion>50% Total viable cell number 1visual microscopic count>10 7 Identity2 FACS > 60 % CD11C+CD86+ Microbiological studies aerobic culture 1no growth anaerobic culture1no growth Fungal Culture1no growth gram stain1no micro-organisms seen mycoplasma test1negative 1Performed on the final product immediately prior to cryopreserva tion. Prepared by: _________________________________________ Date: _____ _______________ QC sign-off: __________________________________________ Date: ____ ________________ Qualified laboratory or Clinical Supervisor QA sign-off: __________________________________________ Date: ________________ ____ Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 58 APPENDIX 3: C ERTIFICATE OF ANALYSIS FOR MATURE PEPTIDE PULSED DENDRITIC CELLS Personalized Dendritic Vaccine Patient: Date of preparation of final product: Tests performed on final product: Test Method Limits Result Tests Performed byInitials/Date Cell viability1trypan blue exclusion>50% Total viable cell number 1visual microscopic countbetween 10 7and 8 X 107 Identity1FACS > 60 % CD11C+CD86+ Microbiological studies aerobic culture 2no growth anaerobic culture2no growth gram stain1no micro-organisms seen fungal culture no growth mycoplasma test2negative Endotoxin1limulus assay <5 E.U./kg 1Performed on the final product prior to infusion. Results are av ailable at the time of infusion.