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PHRM 828 Exam 3 > Byrn Lectures > Flashcards

Byrn Lectures Flashcards

1
Q

Polio Vaccine

A
  • brought to public in 1955
  • bore a Lilly label
  • Polio cases dropped from 1000’s to 53
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2
Q

4 Types of COVID Vaccines

A

mRNA
Vector
Protein Subunit
Whole, killed

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3
Q

mRNA

A
  • used by Pfizer, Moderna
  • mRNA used to instruct cells to make a piece of spike protein
  • coated in fatty lipids to protect it
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4
Q

Vector

A
  • used by Janssen, AstraZeneca, Sputnik
  • used adenoviruses to carry genetic instructions for spike protein
  • attach to cells and inject DNA to tell cells to make spike protein
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5
Q

Protein Subunit

A
  • used by Novavax, Sanofi
  • get small pieces of the target virus circulating into the system by engineering insect viruses used to infect moths that the cells are used then to create spike protein
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6
Q

Whole, Killed

A
  • used by Sinovac
  • batches of the virus are grown and then killed using chemicals or heat
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7
Q

Novavax COVID/FLU combo Vaccine

A
  • launched a phase 1/2 trial
  • tested in 640 healthy adults aged 50-70
  • must have been injected by COVID-19 or vaccinated
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8
Q

Stability of RNA

A

-70 degrees is stable at this temperature over 32 days

RT is degraded over 32 days (can be thawed for an hour and be given at RT safely without degradation)

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9
Q

Ionizable Lipids

A
  • capsulate RNA in lipids to prevent being hydrolyzed
  • positive charged at acidic at pH
  • neutral in the blood
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10
Q

Ionizable Cationic Lipid

A

ALC-0315 (Pfizer) & SM-102 (Moderna) at a pH of 6.2-6.4

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11
Q

Helper Lipids

A

DSPC, Cholesterol, Zwitterionic at pH of 7.5

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12
Q

PEG-Lipid

A

ALC-0159 (Pfizer) & PEG-DMG (Moderna)

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13
Q

Manufacture

A
  • dissolve lipids in ethanol in solution 1
  • dissolve nucleic acid (RNA) in buffer in solution 2
  • mix the two solutions together
  • FORMS LIPID NANOPARTICLES (dense)
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14
Q

Moderna Patent

A
  • Luciferase: protein in lightening bugs
  • recognition tactic to show if the mRNA was formed
  • cationic lipid + DSPC + cholesterol + PEG-lipid
  • diluted to 0.2 mg/ml in a citrate buffer and then the ethanol was mixed with RNA.
  • Ethanol was then removed and replaced with PBS by dialysis
  • Ratio
    50:10:38:1.5
  • Total Lipid:RNA ratio
    10:1
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15
Q

Microfluidics

A
  • inject 3 green tubes injecting drug into plate making the nanoparticle
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16
Q

Solute

A

material being dissolved

typically a solid

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17
Q

Solvent

A

used for drugs to dissolve the solid

ex. alcohol, water, buffers, isopropyl alcohol, glycerine, propylene glycol

18
Q

Oral Solutions

A

drug in solvent including water

19
Q

The solution dosage form reaches higher blood levels than the solid dosag form because:

A

The drug is already in solution
It takes longer for solid to dissolve

20
Q

Syrup

A
  • a drug in solution containing sugar or a sugar substitute
  • may contain antimicrobial preservative
21
Q

Elixir

A

clear sweetened solutions containing a drug and alcohol

22
Q

Nonaqueous Solutions

A

Liniment

23
Q

Biological Products

A

Peptides - insulin
Monoclonal Antibodies - Humira
Proteins
Immune enhancing agents
Cell Therapy
Vaccines

24
Q

Biological Formulations

A

typically solutions or freeze dried (lyphilized)

25
Q

Insulin Ingredients

A

Glycerine, Metacresol Phenol –> Stabilizers

Zinc –> Complexing Agent

Protamine Sulfate –> Delay of Absorption

Sodium Phosphate –> Buffer

HCl, NaOH –> pH Adjusters

26
Q

Common Biological Dosage Forms

A
  • Solutions in vials
  • Freeze dried vials with power (must add water)
27
Q

Stress of Freezing

A
  • feared quality of issues are aggregates
  • aggregates can cause immune responses
  • higher OD, more aggregates
  • mediate aggregates by different pH levels during cooling
28
Q

Surfactants

A

Polysorbate 80 allows us to stabilize the aggregates

29
Q

Small Molecules vs Antibodies

A

Small
- structure is simple and well-defined
- predictable chemical process
- identical copy can be made
- easy to characterize
- stable
- low potential of immunogenicity

Antibody
- structure is complex, with many PTM
- each manufacture is unique
- similar copy can be made but not identical
- difficult to characterize due to mixture of related molecules
- sensitive to storage and handling
- high potential of immunogenicity

30
Q

Sensitivity of mAbs

A
  • PTM are affected by manufacturing processes
  • PTM can effect mechanism of action, bioavailability, clearance, immunogenicity, effector functions, and binding
31
Q

Drug Product Manufacturing

A
  • sterile filtration of drug to get out the microbes
  • container closure integrity and possibility of lyophilized
32
Q

Container Closure Considerations

A
  • depyrogenation of glass vials (dry heat and autoclaving)
  • Steam and pressure sterilization
  • Test materials
  • Leaching and hemolysis
33
Q

Drug Substance Chacterization

A
  • should be positive for identity and specified for purity, potency, and microbial contamination
  • acceptance criteria should be established
  • results of stability should be given to IND
  • Data of characterization should be given to IND
34
Q

Specifications of Drug Substance

A

Identity
Purity
Impurities
Potency
Quantity
Safety

35
Q

Specifications for Drug Product

A

Appearance
Identity
Purity
Quantity
Potency
Safety
Physical
Particulate

36
Q

BioProcess Design Criteria

A

Quality: purity, sequency, glycosylation, activity

Concentration

Productivity

Yield

37
Q

Advantages and Disadvantages of Cell Lines

A

Advantage
- produce human-like proteins
- secrete proteins
- correctly constructed and active proteins

Disadvantage
- slow growth rate
- low cell densities and productivity
- sensitive to fermentation conditions

38
Q

Type of Cell Lines Effect

A

Feeding Regime

Down-Stream Processing

Scale

Bioreactor

39
Q

Type of Bioreactor Depends On…

A

Are cells anchored or suspended?

Cell Density Mixing –> homogenous conditions throughout

Oxygen transfer rate

CIP/SIP

Shear Resistance

40
Q

Process of Fermentation

A

Definition of Product
Selection of Producing Organism
Strain Screening
Medium Optimization
Small Scale Bioreactor
Control Requirements
Scale-Up

41
Q

Types of Chromatography

A

Streamline
Index
Chromaflow
BPG
FineLINE
BioProcess Stainless Steel

SEE SLIDE 49

42
Q

ICH Documents for Biologics

A

Q5 A: viral safety
Q5 B: genetic stability
Q5 C: product stability
Q5 D: cell substrate
Q5 E: comparability
Q6 B: specification
M4/M2: CTD
Q7: GMP for API
Q8: Pharmaceutical Development
Q9: Quality Risk Management
Q10: Pharmaceutical Quality System
Q11: Development and Manufacture of Drug Substance

PHRM 828 Exam 3 (2 decks)

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