Exam 03/04/2017, 3 hours
Kaspar Part (as usual)Describe CDS, CIP, WFI.
Name important cell culture media components? Desired and undesired ones? Supplements?
Elements of drug manufactoring process.
Extractables and leachables?
Advantages of disposables?
PER.C6 – How is the cell line generated? Applications? Two processes with different modes?
Scheme of generation of BEVS ?
Table insect vs. mammalian cells.
Table Sf9 vs. High Five.
Which parameters influence product quality during cultivation?
Diagram with oxygen concentration.
Jungbauer Part#1 You run an isoelectric focussing of a protein in 100 mL at 4000 V and 1 mA.
a.) calculate power consumption
b.) calculate change of temperature per minute without cooling system (assume that buffer has same properties as water)
c.) Are the given conditions realistic?
#2 Somebody hypothesizes that DNA removal is not sufficient because DNA fragments of 250 bp can also be oncogenic.
a.) calculate allowable DNA concentration by assuming the safety factor
b.) calculate the reduction of safety factors if the 10 pg DNA per dose were kept
c.) what other measures could you take to reduce the risk?
Good Luck
Exam was supervised by tutor.
Only Jungbauer script allowed plus books like Doran.