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PHRM828 > Exam 3 Byrn > Flashcards

Exam 3 Byrn Flashcards

1
Q

What are microfluidics?

A

A way to mix by altering the structure or configuration of a fluid channel (used to help with vaccines) Anderson

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2
Q

Lipids in SLN (solid lipid nanoparticles)

A

What the covid vaccine uses, pfizer and moderna have the same helper lipids but they have different ionizable cationic lipids and different PEG-lipids

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3
Q

mRNA-1723 is

A

Moderna

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4
Q

BNT162b2 is

A

Pfizer

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5
Q

SM-102 can possibly be a replacement for…?

A

MC3 lipid because of closely resembled structure

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6
Q

What are 2 characteristics of lipid nanoparticles?

A

Densely packed lipids
Contain nucleic acids

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7
Q

How are SLN (solid lipid nanoparticles) manufactured?

A

By mixing lipids in ethanol in solution 1, mix nucleic acid dissolved in acid buffer in solution 2
Two channels
Mix with syringe pump or flow system

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8
Q

Stability of RNA and does liquid storage or lyophilized storage have a longer half life?

A

Liquid storage at room temperature starts to decrease after 8 days and stays decreasing
Lyophilized storage (freeze drying) stays good for longer and doesn’t start losing RLU until about day 16.
Lyophilized storage > Liquid storage

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9
Q

When was the polio vaccine produced and what happened?

A

Lilly came out with the vaccine in 1955, was produced until 1968 total case numbers went from tens of thousands down to 53.

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10
Q

What are the 4 different types of vaccines being updated and used to make rolling out a vaccine more assessable

A

mRNA vaccine
Vector vaccine
Protein subunit vaccine
Whole, killed vaccine

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11
Q

Facts for the mRNA vaccines?

A

mRNA vaccines are the newest type of vaccine, they instruct cells to make a piece of the coronavirus spike protein which will attract the immune system and create a defense for any future contact

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12
Q

Facts for vector vaccines?

A

Vector vaccines are close to mRNA vaccines but they attach to cells and inject DNA which will instruct it to make the coronavirus spike protein

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13
Q

Facts for protein subunit vaccine

A

They infect animals with covid and then harvest the spike proteins which will then be made into a vaccine

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14
Q

Facts for whole, killed virus vaccine?

A

Coronavirus is grown and then killed by chemicals or heat which will then be made into a vaccine which can be injected to create an immune response, takes longer than the others to produce

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15
Q

What is novavax working on?

A

Novavax is currently in early stage trials for a combo vaccine for flu and covid-19

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16
Q

Analytical procedure lifestyle

A

Is a way to understand and encompass all activities of design, development, validation, and retirement

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17
Q

Typical biotech manufacturing process?

A

Genetic development -> Cells banks -> Drug substance production -> Drug product production (all of these are highly regulated)

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18
Q

What is synthetic post-translational modification?

A

When PEG -polyethylene glycol is attached to a protein to…..
prolong half life
increase solubility
reduce immunogenicity
increase resistance to proteolysis (breakdown of enzymes)

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19
Q

How does PEG effect neulasta (pegfilgrastim)?

A

PEG prolongs its half-life by reducing renal clearance

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20
Q

Half life of filgrastim vs half life of PEGfilgrastim?

A

3hrs vs 15-80hrs

21
Q

What type of process is fermentation?

A

An upstream process

22
Q

What is upstream process?

A

When biological materials are obtained from an outside source or inoculated and grown in culture under controlled conditions which will lead to a downstream process

23
Q

What are the steps in the upstream process?

A

Clear definition of product
Selection of producing organism
Strain screening (can come from strain improvement)
Medium optimization
Small scale bioreactor culture
Process control requirements
Scale up >100L
-> if yield is ok then move to downstream process

24
Q

What is downstream process?

A

Downstream process is when the products from the upstream process are harvested, tested, purified and packaged

25
Q

What are the steps in the downstream process?

A

Biomass/product separation
Product purification
Concentration, crystallization, drying
Fill-finish
Storage, stability
Clinical trials
Marketing

26
Q

FDA and EMA approved biopharmaceuticals from 1982-2014 and 2010-2014

A

ecoli 71 vs 10
yeast 41 vs 9
CHO 81 vs 19
Human 6 vs 2
Mis. mamalion 39 vs 9
Chlorus 8 vs 5

27
Q

What is gene cloning?

A

Replication, amplification and cell division
Genetically modified organism expressing protein of intrest

28
Q

What is MCB

A

Master cell bank (is cryopreserved un aliquots in liquid nitrogen)

29
Q

What is WCB

A

Working cell bank (derived from vials from the MCB

30
Q

What composes the two-tiered cell banking system

A

Master cell bank (MCB)
Working cell bank (WCB)

31
Q

What are traits of MCB?

A

It is established from a single clone
Represents a cell reserve (frozen in time)
-prevents characteristics
-prevents contamination and deterioration
Produced in accordance with regulatory standards

32
Q

What do successful cell banks include?

A

Maintenance of a single master cell line
Working cell banks with low passage numbers
Identity confirmation by DNA fingerprinting
Purity testing including mycoplasma, virus, and fungi
Stability testing for expression constructs

33
Q

What is the stability program?

A

A way for the FDA to test a products stability over time by using a multitude of stress studies

34
Q

What is biologics manufacturing?

A

Biotechnology is technology based on biology that harnesses cellular and bimolecular process to develop medicines

35
Q

What is the history behind biologics (The process is the product)

A

DS (drug substance) manufacturing
-expression system
-Gene expression / protein production
-Cell culture
-Harvesting
-Protein purification
DP (drug product) manufacturing
-formulation
-fill / finish

36
Q

Drug substance characterization?

A

A way to gain an understanding of the physical and chemical properties of pharmaceutical materials
Safety
Purity
Identity

37
Q

Role of stabilizing with surfactants?

A

They can increase particle counts with multiple freeze-thaws

38
Q

Stabilize by drying to a solid

A

-water can be a reactant
-solids are rigid
-non-reactive configurations
-limited mobility to adopt new configurations

39
Q

Stabilize by drying to a solid (a small molecule example)

A

Solutions at 25 degrees C are more likely to degrade each month than a dry solid

40
Q

What are the 2 common biological dosage forms?

A

Solutions in vials
Freeze dried vials with powder

41
Q

What are the solution formulations of biologicals?

A

Drug
Buffers -pH control
Stabilizer
Soulubilizer
Tonicity modifier
Insulin ingredients

42
Q

Does oral tablet or solution have a greater concentration while given the same dose?

A

Solution (digoxin dosing)

43
Q

Definition of syrup?

A

Typically a drug solution containing sugar or a sugar substitute
-sometimes contains an antimicrobial preservative

44
Q

Definition of elixir?

A

Clear sweetened solutions containing a drug or alcohol
-antihistamine elixir

45
Q

non-aqueous solutions?

A

-liniment - minimum water - alcoholic or other types of solutions

46
Q

What can go wrong with the quality of solutions

A

Ethylene glycol contamination of syrups and elixirs have killed hundreds of people
1937 sulfonamide elixir scandal
Numerous incidents in Africa, Panama, and Hati killed hundreds
2022 - dozens of children in Gambia died after taking a few sips of cough syrup contaminated with ethylene glycol

47
Q

Prescribing information for capsules

A

Lactose monohydrate
Mangensium stearate
Sodium lauryl sulfate
Sodium starch glycolate

48
Q

Prescribing information for tablets

A

Croscarmellose sodium
Hydroxypropyl cellulose
Lactose monohydrate
Mangensium stearate
Microcrystalline cellulose
Sodium lauryl sulfate

PHRM828 (3 decks)

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