IVT
What is the expiration of WFI once added to the WFI bag
24 hours
Max volume of TK3018
500 L
What is the pendotech used for
To monitor pressure
What strain of bacteria is used in the DNA
Escherichia coli (E. coli)
How large is the mRNA (unit=kDA)
350 kDA
What is the most expensive reagent added to the IVT SUM
Clean Cap
How many dia-volumes are required at DF1 and DF2?
5 and 10
How long does the filter used in final filtration gets flushed with WFI for, for Filter integrity testing
30 Minutes
How many MBR do we have (Letters or processes)
6
(A, B, C, D, E, Z)
What is the suite J phone number
3731
How many Bolus additions occur during the process 2 scale?
11
How many dilutions occur in the UF record?
2
What is the target weight of buffer to flush through the filter
10.0 Kg
What does VPE stand for in SoloVPE
Variable Pathlight Extension
The differential Pressure between retentate and permeate pressure should not be greater than what during diafiltration?
7 psig
After what reagent being added to the SUM, do we install the temperature probe?
Initial UTP (UTP)
What is the total membrane area for the membranes at the 112L scale
21.0 m^2
What is the target pump speed during Final Filtration
70 RPM
What grade is suite J
Grade D
What is the horsepower of the UF1062 pump
3 HP
What is the order of reagents added to the sum during the process 2 scale
WFI, Clean Cap, ATP, CTP, Initial GTP, Initial UTP, 10X, Ribolock, DNA, WFI, T7, Bolus, CaCl2, Dnase, EDTA, ProK
What is the Transmembrane Pressure (TMP) control limit (PSI) during Diafiltration?
7.5-20.0 PSI
What is the target grams of mRNA to add to each FFT bag during fill
20.1
Name 5 variants manufactured in Suite J
WT, Omicron BA.1, Omicron BA.2, Omicron BA.4/5, WT b7, Omicron B.A 4/5 b7, XBB 1.5, XBB 1.6, Omicron JN.1, Omicron KP.2)
What is the next major process step performed after Suite J Dispense
Thaw or Dilution
2x points for answering Dilution