What product requires media supplementation for passage operation?
HER2
100
What did we use to use in place of the dO2 simulator to capture the zero of a dO2 probe during batching?
Nitrogen
100
2C4 is used in conjunction with _____ for patients who do not respond well to ____ alone.
HER2, HER2
200
POMS
What is Production Operation Management System?
200
___ is used by the DCU to decrease the pH and ___ is used to increase the pH.
Carbon Dioxide (CO2), Sodium Carbonate (NaCO3)
200
What are the four critical parameters controlled by DCU3 for the 20L STB?
dO2, pH, temperature, agitation
200
Why do we have designated warm rooms in SLA and 20L Room?
Originally were going to be used for in process 9L spinner cultures.
200
How many phases of clinical trials are there?
Four
300
EMM
What is Environmental Microbiology Molecular?
300
The _____ to glucose ratio of CCF indicates the step of the Krebs cycle the cells are in.
lactate
300
Which SAP bin do we transfer culture to for an 80L inoc?
B1R3007CCM
300
Per our CCS business practice, what is the maximum time a 20L STB can maintain culture?
8 weeks
300
Which clinical products did Vacaville produce in 2009?
2H7, Rituxan SC, and Actemra
400
gWiz
What is Genentech Wide Information Zone?
400
The smaller the pore size of a filter, the slower the filtration. What is the only small volume addback that we filter through a small pore anti-viral filter assembly?
BONUS points for filter item number.
28 g/L Lipid Ethanol, filter item 12103
400
How many large alcohol wipes per pack?
30
400
In what year was E25 last produced in Vacaville?
2001
400
Actemra was recently approved by FDA to treat what?
rheumatoid arthritis (RA)
500
SAP
What is System, Applications, and Products in data processing software?
500
Name 2 of the 8 components that make up a HER2 media kit.
Combination non-selective media
D-glucose anhydrous
L-Tyrosine
Folic Acid
Gentamycin Sulfate
Pluronic F-68 Prill
Sodium chloride
Super supplements.
500
Name all products that are approved for processing in Vacaville per SOP 1700.004?
HER2, C2B8, E25, 2H7, VEGF, MRA.
500
What additional information was previously recorded on the 20L STB tickets which is no longer required?