Phrm 866 Exam 3 Flashcards
(116 cards)
1
Q
Antibody — __#_ chains of Amino Acids Joined by _____ Bonds
A
4 chains
disulfide bonds
2
Q
Antibodies are also known as ________
A
immunoglobulins (Ig’s)
3
Q
The ___ end of an antibody has amino acids arranged in one of five constant sequences or patterns.
A
Fc
4
Q
T or F: the Fc sequence of an IgG molecule is identical for all IgG molecules in all of us
A
true!!!
5
Q
T or F: Fc sequence of all IgM molecules is identical in all of us, but different from that of IgG
A
true!!!
6
Q
the ____ sequence an antibody, some aminoacids arranged in a highly variable sequence.
A
Fab
7
Q
What are the 5 antibody classes
A
IgG IgM IgD IgA IgE
8
Q
What antibody classes are seen as monomers only
A
IgG
IgE
IgD
9
Q
which antibody class is seen as a pentamer and has J chain in the middle of the pentamer
A
IgM
10
Q
what is the J chain?
A
The J chain is a polypeptide joined to the pentamer by disulfide bonds
11
Q
which antibody class is seen as a polymer or monomer
A
IgA
12
Q
The ________ portion of an antibody selectively binds to a particular antigenic determinant.
A
variable Fab
13
Q
What is antibody specificity? (aka the lock and key mechanism)
A
An antibody coded for one antigenic determinant will bind to that determinant and no other.
14
Q
Secretory _____ has a secretory Chain
A
IgA
15
Q
Secretory IgA:
found where?
A
in body secretions…
predominantly those of the respiratory
and gastrointestinal tracts.
16
Q
The SC chain is believed to protect the IgA molecule from __________ found in respiratory and gastrointestinal secretions
A
proteolysis by enzymes
17
Q
IgM or IgG?
which one is seen has long term immunity/memory
A
IgG
18
Q
IgM or IgG?
will have initial rising of antibody levels quickly (within first week or two of exposure)
A
IgM
19
Q
IgM or IgG?
increase in this antibody is seen after exposure of an antigen for the SECOND time (after first response)
A
IgG
20
Q
Antibody Naming Rules:
-o-
A
mouse
21
Q
Antibody Naming Rules:
-u-
A
human
22
Q
Antibody Naming Rules:
-zu-
A
humanizes
23
Q
Antibody Naming Rules:
-xi-
A
chimeric
24
Q
-xizu-
A
chimeric humanized
25
what does HAMA stand for
human against mouse allergic (reaction)
26
Therapeutic antibodies mainly delivered via ____ route
SQ
27
Many therapeutic mAbs are ____ concentration products
HIGH
28
Many therapeutic mAbs are high concentration products
| often > ____ mg/mL
100 mg/mL
29
________ in viscosity with increasing protein concentration
exponential increase
30
Exponential increase in viscosity with protein concentration -- will lead to:
- Difficulty in ________
- _______ times
- Increased ________ upon administration
“syringability”
long admin times
pain perception
31
types of incompatibilities of CSPs?
- Chemical incompatibility
- Physical incompatibility
- Y-site incompatibility
- Pharmacological incompatibility
32
Chemical or Physical Instability?
| Denaturation
physical
33
Chemical or Physical Instability?
| Deamidiation
chemical
34
Chemical or Physical Instability?
| Aggregation
physical
35
Chemical or Physical Instability?
| precipitation
phsyical
36
Chemical or Physical Instability?
| Racemization
chemical
37
Chemical or Physical Instability?
| oxidation
chemical
38
Chemical or Physical Instability?
| adsorption
physical
39
Chemical or Physical Instability?
| beta elimination
chemical
40
Chemical or Physical Instability?
| disulfide exchange
chemical
41
Which type of incompatibility? (chemical, physical, Y-site, pharmacological)
Refers to formation of turbidity, haze, or a precipitate, or to sorption of drug to a container or IV delivery system
physical
42
Which type of incompatibility? (chemical, physical, Y-site, pharmacological)
Product is unsuitable for administration because of chemical reaction (oxidation, hydrolysis, deamidation, and so forth)
chemical...
43
Which type of incompatibility? (chemical, physical, Y-site, pharmacological)
Occurs when two or more drugs administered concurrently result in undesirable antagonistic or synergistic action
pharmacological
44
Labeling Guidelines:
Labeling required if the CSP.....
-is not _________
-is ______________
if NOT administered immediately
is administered by a different person
45
Labeling Guidelines:
| Label conforms to what things?
federal, state and local laws and regulations
46
```
Labeling Guidelines:
Labels are printed
in ______ format,
easy to read and
free of ______
```
standardized format
| free of obliterations
47
Labeling Guidelines:
| Labels are firmly ______
affixed
48
Labeling Guidelines:
| T or F: Metric system or apothecary measures should be used
FALSE
| metric system only!!
49
Labeling Guidelines:
| T or F: No locally assigned names, numbers or abbreviations
true!!
50
Minimum USP <797> label requirements:
_____ date
Use distinct labeling for solutions intended for what 5 things?
beyond use date
| irrigation, cardioplegia, intrathecal and epidural injections and peritoneal dialysis
51
Minimum USP <797> label requirements:
| T or F: Route of administration is needed
true! (do just let it up for interpretation!!)
52
Minimum USP <797> label requirements:
______ conditions
_______ labeling to emphasize the most critical aspects
```
storage conditions (fridge or freezing)
Auxiliary labeling
```
53
T or F: it is best to use auxiliary labels all the time
False!! do not over use!! (like alert fatigue!! - we just become numb to it)
54
Minimum USP <797> label requirements:
| Name of drug, preferably ______ (may do _____ if it helps decrease confusion)
prefer generic; may do trade name
55
Minimum USP <797> label requirements:
| T or F: you must have other ingredients and volumes
true!!
56
HEPA Filters:
| Remove _____% of all air particles ____ or larger
99. 97%
| 0. 3 um (micrometers) or larger
57
Pinal highlighted what particle that is caught by the filter?
Pseudomonas diminuta ATCC!!
58
what does HEPA stand for?
high efficiency particulate airs
59
IV vs SC admin of Antibodies:
SC has lower ______ and ____
SC has greater _________
(compared to IV!)
lower bioavailability and Cmax
| greater tmax
60
Antibodies are large usually > ____ kD
100
61
Antibody Lecture:
MW < 5 kD --> Mainly _______ absorption
MW > 100 kD --> Mainly _______ absorption
capillary
lymphatic
62
What is the term for this definition?
| Occurs when two or more drugs administered concurrently result in undesirable antagonistic or synergistic action
Pharmacological Incompatibility
63
What is the term for this definition?
Product is unsuitable for administration because of chemical reaction (oxidation, hydrolysis, deamidation, and so forth).
chemical instability
64
What is the term for this definition?
| Refers to formation of turbidity, haze, or a precipitate, or to sorption of drug to a container or IV delivery system
physical instability
65
Precipitation will occur whenever the _______of the drug is exceeded
solubility
66
Large ions (e.g., heparin) can form complexes with __________ (e.g., aminoglycosides) and precipitate
oppositely charged drugs
67
Turning insoluble drugs into _____ form helps solubilize them
ionic (ex: add a base to a poorly soluble acid)
68
Acidic drugs are generally less soluble (i.e., physically less stable) in ______ solutions
acidic
69
T or F: Lipids should never be added to dextrose before amino acids
true!!!
70
______ (a surfactant) can produce anaphylactic shock (paclitaxel)
Chremophor
71
Drugs solubilized with cosolvents can precipitate upon ______ (in a vial or in a vein)
dilution
72
T or F: Acid salts and bicarbonate are incompatible
trueee
73
______ is a Surface phenomenon
Adsorption
74
______ drugs can absorb into plastic administration sets, especially those made of PVC
lipophilic
75
Lipophilic drugs can absorb into plastic administration sets, especially those made of ____
PVC
76
Oil emulsions (e.g, PN) leach plasticizers from plastic containers, that is why they should be packaged in _____ containers only
glass
77
Hydrolysis is highly dependent on_______ and _____
temperature and pH
78
Laminar flow hoods have UV lamps – It is best to have the UV light on when the hood is _____
empty (because UV could damage drugs!!)
79
LVP (l a r g e v o l u m e p a r e n t e r a l )
| Often used to administer __________
multiple medications
80
Y-site
Can reduce the potential for __________
Care must be taken in _______ site as needed
incompatibilities
| flushing
81
ISO Classes:
| _____ number = better air quality
lower number
82
For CSPs:
Store in _______ until time of use (except) if intended for prompt administration
Let reach __________ before administration
fridge
| room temperature
83
what is the best type of HEPA filter
Type C
84
A HEPA filter vs HEPA A filter......
A HEPA = generic ass filer --- 55% removing partilcles
| HEPA A = a good filter (not best that is C) -- 99.7% of removing particles
85
T or F: best to test and certify equipment for sterility/filter effectiveness when no one is using it
FALSE! -- people are biggest contaminators-- make it realistic --- so have people use it
86
T or F: Laminar flow hoods are sterile
FALSE!! they are NOT - we try to make them clean as possible but they are never actually sterile
87
```
Protein Structure (primary, secondary, tertiary or quaternary?)
amino acid sequence of a protein and all covalent modifications, except disulfides
```
primary
88
```
Protein Structure (primary, secondary, tertiary or quaternary?)
local specific structures of a protein caused by hydrogen bonding, electrostatic, interactions, van der Waals forces, etc
```
secondary
89
```
Protein Structure (primary, secondary, tertiary or quaternary?)
final 3-dimensional structure of a single protein chain resulting from intramolecular interactions
```
tertiary
90
```
Protein Structure (primary, secondary, tertiary or quaternary?)
The 3-dimensional structure of a two or more protein chains resulting from inter-molecular interactions
```
quatenary
91
Unlike small molecules, ______ (here we will focus on peptides and proteins) possess a great deal of structural diversity due to their primary, secondary, tertiary and quaternary structures
biologicals
92
T or F: Chemical and physical instability can be very detrimental to the function and safety of biologicals
true af
93
what are the 5 forces that maintain the structure in peptides/proteins
```
covalent bonds
electrostatic interactions
polar-interactions
hydrophobic interactions
solvation
```
94
what type of interaction is hydrogen bonding
electrostatic
95
________ oxidation is not a major pathway for protein degradation and is difficult to predict.
methionine
96
T or F: Methionine oxidation is a major pathway for protein degradation and is difficult to predict.
FALSE - it is NOT a major pathway (but it is difficult to predict)
97
Almost all protein and peptide formulations are designed to be or near the pH of maximum stability of the protein, usually between pH ____ and ___
4.5 - 7.5
98
Recombinant Protein Production:
| ______ a gene into a cell allows for mass production (expression) of a protein
Transfecting
99
Recombinant Protein Production:
| Synthesis for large peptides is expensive and difficult to perform in _______
large quantities
100
Recombinant Protein Production:
| T or F: Bacteria do not provide post-translational modification
true!! bacterial does not! (but Chinese Hamster Ovary (CHO), COS, Baby Hamster Kidney cells, and yeast cells can do post translational modification)
101
Knipp Lecture:
| _____ are Peptide/protein epitopes added to the protein
fusion tags
102
Knipp Lecture:
| Fusion Tags -- can help with _________ and tag sequence must __________
help w/ immunopurification
MUST NOT be similar to that of cell
103
T or F: Fusion tags can enable easier protein purification.
true!! (you are able to look for the tag...)
104
Knipp Lecture -- Purification:
| ______ cells generate more proteins, and thus complicates purification
Mammalian
105
T or F: E. coli does not add post translation modiciations
true!! (it does not!! (bacteria does not!!)
106
Often glycosylation or another PTM can be detected as _____ by the immune system in humans
foreign (why what cell is used for making a biologic is important)
107
Upon completion of purification, the protein is now out of ___________ and formulations must be developed to stabilize it for clinical use.
its cellular environment
108
Epitope tagging is one way to improve purification through _____________ (antibodies on a column)
affinity chromatography
109
Lyophilized products have excipients that ______ to stabilize the dried protein
replace water
110
Proteins formulated in solution have excipients that ________ and stabilize the product.
increase water binding
111
_____ have multiple alcohol moeities that create preferential hydration.
Polyols
112
_______-bind metals that might cause oxidative stress of induce instability due to metal binding to the protein.
metal chelators
113
____________ can stabilize proteins through stoichiometric binding or by forming liposomal like structures
Phospholipids and fatty acids
114
______ is a good additive that possesses fairly high stability.
- It can prevent aggregation and surface adsorption on glass.
albumin
115
______ can be used to prevent oxidative damage to Met, protect disulfide bonds , and potentially stabilize a protein.
Antioxidants
116
Manual or automatic defrost freezers are best?
manual!! (Automatic will change temps all the time to keep it from frosting over...)
