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PHRM 828 Exam 3 > Byrn Lectures > Flashcards

Byrn Lectures Flashcards

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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

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A

used for drugs to dissolve the solid

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

18
Q

Oral Solutions

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A

drug in solvent including water

19
Q

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

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A

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

20
Q

Syrup

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

Elixir

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A

clear sweetened solutions containing a drug and alcohol

22
Q

Nonaqueous Solutions

23
Q

Biological Products

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A

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

24
Q

Biological Formulations

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A

typically solutions or freeze dried (lyphilized)

25
Insulin Ingredients
Glycerine, Metacresol Phenol --> Stabilizers Zinc --> Complexing Agent Protamine Sulfate --> Delay of Absorption Sodium Phosphate --> Buffer HCl, NaOH --> pH Adjusters
26
Common Biological Dosage Forms
- Solutions in vials - Freeze dried vials with power (must add water)
27
Stress of Freezing
- feared quality of issues are aggregates - aggregates can cause immune responses - higher OD, more aggregates - mediate aggregates by different pH levels during cooling
28
Surfactants
Polysorbate 80 allows us to stabilize the aggregates
29
Small Molecules vs Antibodies
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
Sensitivity of mAbs
- PTM are affected by manufacturing processes - PTM can effect mechanism of action, bioavailability, clearance, immunogenicity, effector functions, and binding
31
Drug Product Manufacturing
- sterile filtration of drug to get out the microbes - container closure integrity and possibility of lyophilized
32
Container Closure Considerations
- depyrogenation of glass vials (dry heat and autoclaving) - Steam and pressure sterilization - Test materials - Leaching and hemolysis
33
Drug Substance Chacterization
- 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
Specifications of Drug Substance
Identity Purity Impurities Potency Quantity Safety
35
Specifications for Drug Product
Appearance Identity Purity Quantity Potency Safety Physical Particulate
36
BioProcess Design Criteria
Quality: purity, sequency, glycosylation, activity Concentration Productivity Yield
37
Advantages and Disadvantages of Cell Lines
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
Type of Cell Lines Effect
Feeding Regime Down-Stream Processing Scale Bioreactor
39
Type of Bioreactor Depends On...
Are cells anchored or suspended? Cell Density Mixing --> homogenous conditions throughout Oxygen transfer rate CIP/SIP Shear Resistance
40
Process of Fermentation
Definition of Product Selection of Producing Organism Strain Screening Medium Optimization Small Scale Bioreactor Control Requirements Scale-Up
41
Types of Chromatography
Streamline Index Chromaflow BPG FineLINE BioProcess Stainless Steel SEE SLIDE 49
42
ICH Documents for Biologics
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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