Protein Stability Flashcards
1
Q
Why is stability important?
A
Homogeneous product characterisation
Prolonged efficacy
Minimisation of product related risk
Predictable manufacturing and controlled costs of goods.
2
Q
What are biopharmaceuticals expected to withstand?
A
High shear forces
Formulated to high []s
Remain chemically active / physically stable for 2Y
Withstand dehydration.
3
Q
Name three drugs that have been successfully lyophilized.
A
Herceptin - Anti-HER2
Xolair - Anti-IgE fro asthma
Mylotarg - Anti-CD33 for AML.
4
Q
What is zeta potential?
A
Measurement of surface charge.
5
Q
How is asparagine deamidated?
A
asymmetric succinimide forms first, then hydrolysed either to aspartic acid or iso-aspartic acid.
6
Q
How is glutamine deamidated?
A
glutamine forms 5-oxoproline
