CMO1030 Trivia
How many batches of CMO1030 do we plan to make?
9
How does harvest process differ from HGS1006/RKV1038?
Parallel filtration
What is the only solution made that is autoclaved?
antifoam
Whose credentials MUST be used on all equipment logins?
Performer
What is defined as: "Operator recorded raw data or information from another source incorrectly (e.g incorrect SOP reference, etc.)"?
Transcription error
Who is the owner of CMO1030 AND what is the brand name?
Pfizer, Retacrit
What compound is used for base control?
Sodium Hydroxide
How long can glutamine be stored for?
7 days
ALCOA+. What is defined as: "Data is recorded at the time of the activity"?
Contemporaneous
What is defined as the individual making the documentation entries?
Recorder
What other continent is CMO1030 produced in?
Europe
What compound aside from glucose is used to “feed” the cells? OR What compound is analogous to our cholesterol additions in HGS1006?
Glutamine
What solutions are made for the harvest process?
none
ALCOA+. What is defined as "Data and metadata must be in a format that is readable, understandable, and permanent."?
Legible
What is defined as “Any documentation that is the result of original observations and activities or certified exact copies.”
Raw data
What type of cell does CMO1030 increase?
Red Blood Cell
Bulkup is performed in which BRX and when?
20K, approx. 24±4H
What size filter is used to reduce mycoplasma?
0.1 µm
ALCOA+. What is defined as: "Date/time stamps/records are in the expected sequence and allow for a complete and accurate representation of data across the data lifecycle."?
Consistent
What is defined as a duplication of an original record or document used for a specific task. It is uncontrolled, will not be updated and is not required to be verified?
True Copy
How many grams of product does one 20K batch of CMO1030 make?
80g
Initiating cooldown is based on which two values?
VCD and viability
What two measurements are used to confirm a solution is prepared properly?
pH and osmolarity
ALCOA+. What is defined as "Permanently recorded on official controlled forms, templates or electronic media and retained through the lifecycle."
Enduring
What are the codes along with initials and date may be used if an error is caught by the person making the entry and at the time the entry was made to the document?
(TE) Transcription Error – Operator recorded raw data or information from another source incorrectly (e.g incorrect SOP reference, etc.)
(ID) Incorrect Date – Operator recorded an incorrect date or used the wrong format (i.e. 14JUNE19)
(CL) Clarity – Operator made illegible entry. (SE) Spelling Error – Operator erroneously checked a box, started filling in the wrong line, misspelled a word, or entered data that was not needed.
(SM) Stray Mark – Operator inadvertently made a stray Mark.