PHRM 866 Exam 1 Flashcards
(98 cards)
what are some biotech products
peptides
proteins
gene therapy
vaccines
Some therapeutic applications of biotech
factors to affect hemtopoyetic cells and blood coagulation
interferons/cytokines (infections and cancer)
hormones and derivs
enzymes
recombinant proteins for vaccines
cell therapy
Recombinant definition?
Using cells (microorganisms or mammalian) as “factories” to produce therapeutic proteins
Cloning definition?
Turning cells into the type of high quality biotech “factory” required for therapy
Example: monoclonal antibodies
MOST biotech drugs are administered by ______
injection
Biotech products are generally more _____, _____, and ______
potent, delicate, expensive,
Protein Drug Review: Primary Struc Secondary Struc Tertiary Struc Quat Struc
primary - chemical sequence
2nd: alpha coils or beta sheets
3rd: 3D structure
4th: multiple 3d units together
What aspect of protein structure results in longer circulation time in the blood?
a) Deamidation
b) Disulfide bridges
c) Tertiary structure
d) Quaternary structure
e) Glycosylation
E - glycosylation
Two examples of excipients used to enhance protein stability in injectable products in solution and in lyophilized form are ____, respectively
a) Glucose and threhalose
b) Heparin and glucose
c) Heparin and trehalose
d) Trehalose and heparin
e) Trehalose and glucose
C - heparin and trehalose
Which of these two products have higher incidence of immunogenicity in patients?
a) Epoietin (human recombinant)
b) IL-2
IL-2
Which of the follow ing is/are typically true of intramuscular (IM) administration of monoclonal antibodies (mAbs)?
A) bioavailability (F) is near 100%
B) bioavailability (F) is 50-80%
C) peak plasma concentration (Cmax) is reached in 2-5 minutes (tmax)
D) peak plasma concentration (Cmax) is reached in several days (tmax)
a) A and C
b) A and D
c) B and C
d) B and D
D
The volume of distribution (Vd) of monoclonal antibodies (mAbs) is:
a) much larger than blood volume, due to extensive extravascular binding
b) much larger than blood volume, due to FcRn (endocytic) rescue
c) approximately equal to total body w ater, reflecting distribution to aqueous fluids in the body
d) approximately equal to blood volume, since the drug is confined to the vasculature
e) none of the above
D - approximately equal to blood volume, since the drug is confined to the vasculature
Which of the follow ing two hematopoietic factors is associated with granulocytes?
a) GM-CSF
b) MGDF
A
The neutrophil count of a patient w ith neutropenia is:a) Below 180 cells/mm3
b) Below 1,800 cells/ mm3
c) Below 180 cells/cm3
d) Below 1,800 cells/ cm3
e) Below 1,600 cells/mL
B - b) Below 1,800 cells/ mm3
The majority of circulating erythropoietin is produced in the
a) liver
b) kidney
c) bone marrow
d) pancreas
e) RES
B - kidney
The follow ing is a long-acting insulin product
a) Humulin R
b) Humulin N
c) Humalog
B - N
USP <797> applies to ___________ of sterile preparations.
a) Compounding
b) Compounding and transportation
c) Compounding, transportation and storage
d) Compounding, transportation, storage and administration
C - Compounding, transportation and storage
Interferons fall in the follow ing category
a) Granulocyte colony-stimulating factors
b) Leukemia inhibitory factors
c) Stem cell factors
d) Interleukins
e) Cytokines
E - cytokines
Avonex®(IFN-b1a, Biogen Inc.) and Betaseron®(IFN-b1b, Berlex) are two different IFN products that
a) Come from the same cell type
b) Come from different cell type
A
Select a correct statement
a) The proteins in both Epogen®and Nupogen®are glycosylated
b) The protein in Epogen®is glycosylated, w hile the protein in Nupogen®is not
c) The protein in Nupogen®is glycosylated w hile the protein in Epogen®is not
d) Neither of proteins in Epogen®or Nupogen®are glycosylated
e) The aminoacid residue chains of both Epogen®and Nupogen®are too short to forthem be considered as proteins
B - The protein in Epogen®is glycosylated, w hile the protein in Nupogen®is not
Hemophilia A and B are associated w ith deficiencies in factors ___, respectively.
a) VI and VII
b) VII and VIII
c) VIII and IX
d) IX and X
e) VI and IX
C - VIII and IX
You are asked to dispense a new monoclonal antibody (mAb)-based drug,Mabtrema®. Due to modifications to the usual mAb structure, Mabtrema®is unable tobind to the neonatal Fc receptor (FcRn). Which of the follow ing properties w ould youexpect for Mabtrema?
a) the plasma half-life is longer than that of a typical mAb
b) the plasma half-life is shorter than that of a typical mAb
c) the plasma half-life is equal to that of a typical mAb
d) it binds Protein A with high affinity
e) it can be given orally
B - the plasma half-life is shorter than that of a typical mAb
Monoclonal antibodies (mAbs) are eliminated by all of the follow ing mechanismsEXCEPT:
a) proteolysis in the liver
b) metabolism by target cells
c) renal excretion of the unmetabolized parent drug
d) phagocytosis by the reticuloendothelial system (RES)
e) binding to antidrug antibodies (ADA) in the bloodstream
C -renal excretion of the unmetabolized parent drug
what amino acids are aromatic
phenylalanine
tryptophan
tyrosine
