Phrm 866 Exam 3 Flashcards by Kappa Epsilon Pi Chapter | Brainscape

Q

Antibody — __#_ chains of Amino Acids Joined by _____ Bonds

A

4 chains

disulfide bonds

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Q

Antibodies are also known as ________

A

immunoglobulins (Ig’s)

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Q

The ___ end of an antibody has amino acids arranged in one of five constant sequences or patterns.

A

Fc

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Q

T or F: the Fc sequence of an IgG molecule is identical for all IgG molecules in all of us

A

true!!!

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Q

T or F: Fc sequence of all IgM molecules is identical in all of us, but different from that of IgG

A

true!!!

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Q

the ____ sequence an antibody, some aminoacids arranged in a highly variable sequence.

A

Fab

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Q

What are the 5 antibody classes

A

IgG
IgM
IgD
IgA
IgE

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Q

What antibody classes are seen as monomers only

A

IgG
IgE
IgD

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Q

which antibody class is seen as a pentamer and has J chain in the middle of the pentamer

A

IgM

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Q

what is the J chain?

A

The J chain is a polypeptide joined to the pentamer by disulfide bonds

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Q

which antibody class is seen as a polymer or monomer

A

IgA

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Q

The ________ portion of an antibody selectively binds to a particular antigenic determinant.

A

variable Fab

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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.

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Q

Secretory _____ has a secretory Chain

A

IgA

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Q

Secretory IgA:

found where?

A

in body secretions…
predominantly those of the respiratory
and gastrointestinal tracts.

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Q

The SC chain is believed to protect the IgA molecule from __________ found in respiratory and gastrointestinal secretions

A

proteolysis by enzymes

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Q

IgM or IgG?

which one is seen has long term immunity/memory

A

IgG

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Q

IgM or IgG?

will have initial rising of antibody levels quickly (within first week or two of exposure)

A

IgM

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Q

IgM or IgG?

increase in this antibody is seen after exposure of an antigen for the SECOND time (after first response)

A

IgG

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Q

Antibody Naming Rules:

-o-

A

mouse

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Q

Antibody Naming Rules:

-u-

A

human

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Q

Antibody Naming Rules:

-zu-

A

humanizes

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Q

Antibody Naming Rules:

-xi-

A

chimeric

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Q

-xizu-

A

chimeric humanized

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Q

what does HAMA stand for

A

human against mouse allergic (reaction)

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Q

Therapeutic antibodies mainly delivered via ____ route

A

SQ

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Q

Many therapeutic mAbs are ____ concentration products

A

HIGH

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Q

Many therapeutic mAbs are high concentration products

often > ____ mg/mL

A

100 mg/mL

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Q

________ in viscosity with increasing protein concentration

A

exponential increase

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Q

Exponential increase in viscosity with protein concentration – will lead to:

Difficulty in ________
_______ times
Increased ________ upon administration

A

“syringability”
long admin times
pain perception

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Q

types of incompatibilities of CSPs?

A

Chemical incompatibility
Physical incompatibility
Y-site incompatibility
Pharmacological incompatibility

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Q

Chemical or Physical Instability?

Denaturation

A

physical

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Q

Chemical or Physical Instability?

Deamidiation

A

chemical

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Q

Chemical or Physical Instability?

Aggregation

A

physical

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Q

Chemical or Physical Instability?

precipitation

A

phsyical

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Q

Chemical or Physical Instability?

Racemization

A

chemical

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Q

Chemical or Physical Instability?

oxidation

A

chemical

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Q

Chemical or Physical Instability?

adsorption

A

physical

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Q

Chemical or Physical Instability?

beta elimination

A

chemical

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Q

Chemical or Physical Instability?

disulfide exchange

A

chemical

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Q

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

A

physical

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Q

Which type of incompatibility? (chemical, physical, Y-site, pharmacological)

Product is unsuitable for administration because of chemical reaction (oxidation, hydrolysis, deamidation, and so forth)

A

chemical…

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Q

Which type of incompatibility? (chemical, physical, Y-site, pharmacological)

Occurs when two or more drugs administered concurrently result in undesirable antagonistic or synergistic action

A

pharmacological

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Q

Labeling Guidelines:
Labeling required if the CSP…..
-is not _________
-is ______________

A

if NOT administered immediately

is administered by a different person

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Q

Labeling Guidelines:

Label conforms to what things?

A

federal, state and local laws and regulations

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Q

Labeling Guidelines:
Labels are printed
in \_\_\_\_\_\_ format, 	
easy to read and 
free of \_\_\_\_\_\_

A

standardized format

free of obliterations

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Q

Labeling Guidelines:

Labels are firmly ______

A

affixed

Q

Labeling Guidelines:

T or F: Metric system or apothecary measures should be used

A

FALSE

metric system only!!

Q

Labeling Guidelines:

T or F: No locally assigned names, numbers or abbreviations

A

true!!

Q

Minimum USP <797> label requirements:
_____ date
Use distinct labeling for solutions intended for what 5 things?

A

beyond use date

irrigation, cardioplegia, intrathecal and epidural injections and peritoneal dialysis

Q

Minimum USP <797> label requirements:

T or F: Route of administration is needed

A

true! (do just let it up for interpretation!!)

Q

Minimum USP <797> label requirements:
______ conditions
_______ labeling to emphasize the most critical aspects

A

storage conditions (fridge or freezing)
Auxiliary labeling

Q

T or F: it is best to use auxiliary labels all the time

A

False!! do not over use!! (like alert fatigue!! - we just become numb to it)

Q

Minimum USP <797> label requirements:

Name of drug, preferably ______ (may do _____ if it helps decrease confusion)

A

prefer generic; may do trade name

Q

Minimum USP <797> label requirements:

T or F: you must have other ingredients and volumes

A

true!!

Q

HEPA Filters:

Remove _____% of all air particles ____ or larger

A

97%

0. 3 um (micrometers) or larger

Q

Pinal highlighted what particle that is caught by the filter?

A

Pseudomonas diminuta ATCC!!

Q

what does HEPA stand for?

A

high efficiency particulate airs

Q

IV vs SC admin of Antibodies:
SC has lower ______ and ____
SC has greater _________
(compared to IV!)

A

lower bioavailability and Cmax

greater tmax

Q

Antibodies are large usually > ____ kD

A

100

Q

Antibody Lecture:
MW < 5 kD –> Mainly _______ absorption
MW > 100 kD –> Mainly _______ absorption

A

capillary

lymphatic

Q

What is the term for this definition?

Occurs when two or more drugs administered concurrently result in undesirable antagonistic or synergistic action

A

Pharmacological Incompatibility

Q

What is the term for this definition?
Product is unsuitable for administration because of chemical reaction (oxidation, hydrolysis, deamidation, and so forth).

A

chemical instability

Q

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

A

physical instability

Q

Precipitation will occur whenever the _______of the drug is exceeded

A

solubility

Q

Large ions (e.g., heparin) can form complexes with __________ (e.g., aminoglycosides) and precipitate

A

oppositely charged drugs

Q

Turning insoluble drugs into _____ form helps solubilize them

A

ionic (ex: add a base to a poorly soluble acid)

Q

Acidic drugs are generally less soluble (i.e., physically less stable) in ______ solutions

A

acidic

Q

T or F: Lipids should never be added to dextrose before amino acids

A

true!!!

Q

______ (a surfactant) can produce anaphylactic shock (paclitaxel)

A

Chremophor

Q

Drugs solubilized with cosolvents can precipitate upon ______ (in a vial or in a vein)

A

dilution

Q

T or F: Acid salts and bicarbonate are incompatible

A

trueee

Q

______ is a Surface phenomenon

A

Adsorption

Q

______ drugs can absorb into plastic administration sets, especially those made of PVC

A

lipophilic

Q

Lipophilic drugs can absorb into plastic administration sets, especially those made of ____

A

PVC

Q

Oil emulsions (e.g, PN) leach plasticizers from plastic containers, that is why they should be packaged in _____ containers only

A

glass

Q

Hydrolysis is highly dependent on_______ and _____

A

temperature and pH

Q

Laminar flow hoods have UV lamps – It is best to have the UV light on when the hood is _____

A

empty (because UV could damage drugs!!)

Q

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 __________

A

multiple medications

Q

Y-site
Can reduce the potential for __________
Care must be taken in _______ site as needed

A

incompatibilities

flushing

Q

ISO Classes:

_____ number = better air quality

A

lower number

Q

For CSPs:
Store in _______ until time of use (except) if intended for prompt administration
Let reach __________ before administration

A

fridge

room temperature

Q

what is the best type of HEPA filter

A

Type C

Q

A HEPA filter vs HEPA A filter……

A

A HEPA = generic ass filer — 55% removing partilcles

HEPA A = a good filter (not best that is C) – 99.7% of removing particles

Q

T or F: best to test and certify equipment for sterility/filter effectiveness when no one is using it

A

FALSE! – people are biggest contaminators– make it realistic — so have people use it

Q

T or F: Laminar flow hoods are sterile

A

FALSE!! they are NOT - we try to make them clean as possible but they are never actually sterile

Q

Protein Structure (primary, secondary, tertiary or quaternary?)
amino acid sequence of a protein and all covalent modifications, except disulfides

A

primary

Q

Protein Structure (primary, secondary, tertiary or quaternary?)
local specific structures of a protein caused by hydrogen bonding, electrostatic, interactions, van der Waals forces, etc

A

secondary

Q

Protein Structure (primary, secondary, tertiary or quaternary?)
final 3-dimensional structure of a single protein chain resulting from intramolecular interactions

A

tertiary

Q

Protein Structure (primary, secondary, tertiary or quaternary?)
The 3-dimensional structure of a two or more protein chains resulting from inter-molecular interactions

A

quatenary

Q

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

A

biologicals

Q

T or F: Chemical and physical instability can be very detrimental to the function and safety of biologicals

A

true af

Q

what are the 5 forces that maintain the structure in peptides/proteins

A

covalent bonds
electrostatic interactions
polar-interactions
hydrophobic interactions
solvation

Q

what type of interaction is hydrogen bonding

A

electrostatic

Q

________ oxidation is not a major pathway for protein degradation and is difficult to predict.

A

methionine

Q

T or F: Methionine oxidation is a major pathway for protein degradation and is difficult to predict.

A

FALSE - it is NOT a major pathway (but it is difficult to predict)

Q

Almost all protein and peptide formulations are designed to be or near the pH of maximum stability of the protein, usually between pH ____ and ___

A

4.5 - 7.5

Q

Recombinant Protein Production:

______ a gene into a cell allows for mass production (expression) of a protein

A

Transfecting

Q

Recombinant Protein Production:

Synthesis for large peptides is expensive and difficult to perform in _______

A

large quantities

Q

Recombinant Protein Production:

T or F: Bacteria do not provide post-translational modification

A

true!! bacterial does not! (but Chinese Hamster Ovary (CHO), COS, Baby Hamster Kidney cells, and yeast cells can do post translational modification)

Q

Knipp Lecture:

_____ are Peptide/protein epitopes added to the protein

A

fusion tags

Q

Knipp Lecture:

Fusion Tags – can help with _________ and tag sequence must __________

A

help w/ immunopurification

MUST NOT be similar to that of cell

Q

T or F: Fusion tags can enable easier protein purification.

A

true!! (you are able to look for the tag…)

Q

Knipp Lecture – Purification:

______ cells generate more proteins, and thus complicates purification

A

Mammalian

Q

T or F: E. coli does not add post translation modiciations

A

true!! (it does not!! (bacteria does not!!)

Q

Often glycosylation or another PTM can be detected as _____ by the immune system in humans

A

foreign (why what cell is used for making a biologic is important)

Q

Upon completion of purification, the protein is now out of ___________ and formulations must be developed to stabilize it for clinical use.

A

its cellular environment

Q

Epitope tagging is one way to improve purification through _____________ (antibodies on a column)

A

affinity chromatography

Q

Lyophilized products have excipients that ______ to stabilize the dried protein

A

replace water

Q

Proteins formulated in solution have excipients that ________ and stabilize the product.

A

increase water binding

Q

_____ have multiple alcohol moeities that create preferential hydration.

A

Polyols

Q

_______-bind metals that might cause oxidative stress of induce instability due to metal binding to the protein.

A

metal chelators

Q

____________ can stabilize proteins through stoichiometric binding or by forming liposomal like structures

A

Phospholipids and fatty acids

Q

______ is a good additive that possesses fairly high stability.
- It can prevent aggregation and surface adsorption on glass.

A

albumin

Q

______ can be used to prevent oxidative damage to Met, protect disulfide bonds , and potentially stabilize a protein.

A

Antioxidants

Q

Manual or automatic defrost freezers are best?

A

manual!! (Automatic will change temps all the time to keep it from frosting over…)