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Lot:
002-001-004-0012
Product:
NK-CAR
Export
MACS
TDX
STOP
FEED
D10 FEED
HARV
Selection
Process Date
Process Start Time
Apheresis Receipt Date
Apheresis Receipt Time
Apheresis Clean Room Arrival Time
Apheresis Volume
mL
Apheresis TVC
x 10
6
Prodigy Start Time
Pre-Prodigy Count
x 10
6
/mL
Pre-Prodigy Viability
%
Pre-Prodigy Recovery
%
Prodigy End Time
Post-Prodigy Volume
mL
Post-Prodigy Count
x 10
6
/mL
Post-Prodigy Viability
%
Post-Prodigy Recovery
%
Culture
Culture Seed Conc.
x 10
6
/mL
Culture Seed Volume
mL
IL-7 Addition Volume
mL
IL-15 Addition Volume
mL
CD3 Addition Volume
mL
CD28 Addition Volume
mL
Culture Incubation Date
Culture Incubation Time
Cryo (Optional)
TVC Remaining
x 10
6
CS10 Addition Volume
mL
CS10 Addition Time
# of Bags Cryopreserved
CRF Start Time
CRF End Time
MVE Storage Time
Bag Coat
Process Date
Process Start Time
TDX Bag type
750-AC
118-AC
290-AC
750-AC
750-AC/290-AC
750-AC (x2)
118-AC (x3)
750-AC/118-AC
290-AC (x2)
Retronectin Added
mL
Plasma-Lyte Added
mL
TDX Coat Start Time Bag 1
TDX Coating End Time Last Bag
Pre-Prodigy Count
x 10
6
/mL
Pre-Prodigy Viability
%
Viable Cell Recovery
%
Prodigy Start Time
Virus Addition
Virus Lot
RETRO 0123
RETRO 1111
RETRO 0123
RETRO 9510
LENTI 1564
LENTI 9842
LENTI 0135
Virus Titer
x10
6
/mL
Product Order MOI
Calculated MOI
Total IFU Required
x 10
6
Total IFU Available
x 10
6
Total Virus Required
mL
Virus Bag 1 Thaw Start Time
Virus Last Bag Thaw End Time
Total Virus Added
mL
Transduction
Prodigy End Time
Post-Prodigy Count
x 10
6
/mL
Post-Prodigy Viability
x 10
6
Post-Prodigy Recovery
%
Cell Volume for TDX
mL
Cell Percent for TDX
%
IL-7 Addition
mL
IL-15 Addition
mL
TDX Seed TVC
x 10
6
TDX Seed Volume
mL
Culture Incubation Date
Culture Incubation Time
Bag Flip Time
Pre-Prodigy
Process Date
Process Start Time
Pre-Prodigy Volume
mL
Pre-Prodigy Count
x 10
6
/mL
Pre-Prodigy Viability
%
Pre-Prodigy TVC
x 10
6
Expansion
%
Prodigy Start Time
Post-Prodigy
Prodigy End Time
Post-Prodigy Volume
mL
Post-Prodigy Count
x 10
6
/mL
Post-Prodigy Viability
%
Post-Prodigy TVC
x 10
6
Recovery
%
Culture Bag
118-AC
118-AC
290-AC
750-AC
750-AC/290-AC
750-AC (x2)
118-AC (x3)
750-AC/118-AC
290-AC (x2)
Culture Volume
mL
IL-7 Addition
mL
IL-15 Addition
mL
Culture Incubation Date
Culture Incubation Time
Process Date
Process Start Time
Feed Count
x 10
6
Feed TVC
x 10
6
Feed Viability
%
Culture Epansion
%
IL-7 Addition
mL
IL-15 Addition
mL
Culture Volume
mL
Culture Incubation Date
Culture Incubation Time
Process Date
Process Start Time
Feed Count
x 10
6
/mL
Feed Viability
%
Culture Expansion
%
IL-7 Addition
mL
IL-15 Addition
mL
Culture Volume
mL
Culture Incubation Date
Culture Incubation Time
Initiation
Process Date
Process Start Time
Product Label Dose
x 10
6
Transduction Factor
Pre-COBE Count
x 10
6
/mL
Pre-COBE Viability
%
Pre-COBE TVC
x 10
6
Culture Expansion
%
Pre-COBE Transduced Cells
x 10
6
Transduced Cells Required
x 10
6
Post-QC TVC
x 10
6
Post-QC Transduced TVC
x 10
6
Concentration
COBE Total Superout
g(mL)
Post-COBE Volume
mL
Pre-Form Pooled Volume
mL
Pre-Form Count #1
x 10
6
/mL
Pre-Form Viability #1
%
Pre-Form Count #2
x 10
6
/mL
Pre-Form Viability #2
%
Pre-Form Count #3
x 10
6
/mL
Pre-Form Viability #3
%
Pre-Form Count Average
x 10
6
/mL
Pre-Form Viability Average
%
Pre-Form TVC
x 10
6
Pre-Form Transduced TVC
x 10
6
Formulation
Formulation Pellet Volume
mL
Number of Doses Available
Formulation Volume
mL
Number of Cryobags
Number of Cryovials
CS-10 Volume Added
mL
CS-10 Addition Time
TVC per Bag
x 10
6
TVC per Vial
x 10
6
Process End Date
CRF Start Time
CRF End Time
MVE Storage Time
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