exam 1 practice

Question 1

List and define the critical quality attributes for biologics discussed in class

Answer 1

Safety – effect on patient health aside from treatment effects
Identity – confirming biologic is what it is supposed to be
Purity – lack of contaminants
Potency – effectiveness of treatment effects

Question 2

What is the benefit of PEGylation of a drug or delivery vehicle?

Answer 2

Reduces interaction with immune system (improves circulation time, reduces immunogenicity, provides “stealth characteristics”)

Question 3

List the components of a lipid nanoparticle

Answer 3

Ionizable lipidoid
Cholesterol
Helper lipid
PEG-lipid
Cargo (e.g. mRNA)

Question 4

Fischellumab is a monoclonal antibody that only has a therapeutic effect upon binding its target protein, which is
located inside pancreatic cells at the mitochondrial surface. How would you deliver this drug to ensure its efficacy, and
what administration method would you use? Justify your decisions

Answer 4

Should be administered IV encapsulated within polymer NP or liposome (incompatible with LNPs) or fused to some other
domain allowing for cell membrane penetration and/or endosomal escape.

Question 5

What transport mechanisms are involved in the escape of intact macromolecules from the bloodstream?

Answer 5

Convection and diffusion
Transcytosis
Paracytosis
Endocytosis

Question 6

Which of the following apply to oral drug delivery?

Answer 6

Allows for easy self-administration
Highly compatible with small molecule drugs
goes thru first-pass metabolism
not fastest possible response time of all common non-parenteral delivery methods

Question 7

Which of the following statements related to parenteral delivery is/are TRUE

Answer 7

Implantable systems offer the longest time of drug release/action
Intravenous injection avoids first pass metabolism
subcutaneous injection does NOT involve the deepest penetration
intramuscular injection does NOT offer the fastest drug access to the bloodstream