Final Exam 2024 Study Guide Prep Questions With Accurate Answers

Potential CQAs {Ans: Examples: Potency, Aggregation, Oxidation, Deamidation}What is a protein formulation? {Ans: The chemical composition of the drug product that is delivered to the patient}Why is the experimental pI is preferred over the theoretical one? {Ans: The experimental pI is preferred as the theoretical one can be wrong for up to 4 pH units, as it doesnt take into account post-translational modifications}What is the usual target residual moisture for a lyo cake? {Ans: Less than 1% 0.5% to 0.9% is ideal 0.2% or lower you may have physical instabilities}What is the challenge in some formulations containing NaCl and glycine as bulking agent? {Ans: The NaCl can inhibit the crystallization of glycine. NaCl also increases the Tg' which is undesirable}What is the utility of large-volume devices (LVD?) {Ans: Allows formulators to use more drug volume without time constraints Not limited by time of injection}Which pH is more likely to have isomerization of DG? {Ans: Acid conditions (low)}Which is the pH that is more likely to have deamidation of NG residues? {Ans: Basic Conditions (high)}What is liquid-liquid phase separation (LLPS)? 1) How could PEG-induced LLPS be helpful in device ability? and 2) formulation