IC11 PR3151

Question 1

Levels of vaccine protection

Answer 1

1: individual
2: herd immunity (community)
3: global
4: future generations

Question 2

Vaccine qualities

Answer 2

1) 100% effective for all ages
2) no side effects
3) stable
4) can kill multiple organisms
5) accessible and inexpensive
6) long term protection with single application

Question 3

viral vector vaccine

Answer 3

process:
extract genetic material > insert into spike protein > injected and genetic material inserted into host cell > protein formed > antibodies created > vector virus broken down.

Question 4

what are vaccine suspension fluids for?

Answer 4

to weaken the germ in the vaccines

Question 5

what are examples and functions of vaccine preservatives

Answer 5

1) formaldehyde

2) phenoxyethanol
- easily eliminated and low toxicity
3) thiomersal
- bactericidal and fungicidal properties

Question 6

what are examples and functions of vaccine adjuvants?

Answer 6

1) aluminium salts
- slow release and increase duration of action of antigen.

2) complete freund (mycobacteria suspended in oil) but may cause inflammation

3) MF59 (oil based)

4) montanide (oil in water)

Question 7

what are vaccine adjuvants

Answer 7

they help to increase the activity of the vaccine antigen

two types:
1) vaccine delivery systems (nano and microparticles)
2) potentiate antigen response via direct stimulation (cytokines) and pattern recognition receptors (PRRs).

Question 8

why are o/w and w/o emulsions adjuvants bad?

Answer 8

toxic and dangerous

Question 9

what are examples and functions of vaccine stabilisers

Answer 9

msg: protect from heat light acidity humidity

gelatin: protect from heat

sorbitol: increases protein stability

buffers: adjust tonicity and osmolarity

Question 10

what are examples of vaccine surfactants

Answer 10

LL M D SS
lecithin
lipopolysaccharide
mannide oleates
DDAB (ammonium…)
sorbitan Esther
saponines

Question 11

what are the bioprocessing steps in vaccines manufacturing and the methods used for each

Answer 11

upstream: antigen or pathogen is generated

midstream: clarification or removal of cell debris and cells
- depth filtration
- centrifugation
- tangential flow filtration

downstream: purification and removal of impurities
- ultrafiltration
- enzyme action
- precipitation
- chromatography

Question 12

dry formulation administration methods

Answer 12

microneedle (intradermal –> pierce stratum corneum)

inhalation

Question 13

reconstituted vaccine adminstration methods

Answer 13

inhalation

injection

Question 14

filling process

Answer 14

lyophilisation
dissolve > 0.22nm > freeze dry > vacuum > heat > evaporate > complete stoppering

Question 15

disadvantages of capping

Answer 15

1) trap moisture
2) lubrication (contaminant)
3) possible source of contamination (debris)

Question 16

registration file review

Answer 16

All materials used for production need to be described in detail

• Any biological materials used in the process need to be screened for possible contaminants (bacteria, viruses)
• Process, process controls, QC tests need to be described
• Containers and process equipment has to be evaluated for possible leaching of elements into the vaccine
• Impurity removal capacity of process needs to demonstrated
• Assessment has to be made confirming the safety of the product
• Any residuals need to be below acceptable safety limits
• All this info has to be included in the registration file, which has to be reviewed and approved by the authorities

Question 17

quality control QC testing includes the following

Answer 17

ppigs

purity
potency (identity, size, integrity, purity)
identification
general parameters
safety (sterility, endotoxins)

Question 18

examples of in vitro potency testing include:

Answer 18

1) Immuno assays via ELISA

IF fail
2) SDS PAGE (based on molecular weight)
3) SEC HPLC (Size exclusion chromatography, SEC)

Question 19

potency of live viral vaccines

Answer 19

Virus titer is measured using in vitro cell cultures

Cells are infected with various dilutions of vaccine
Cell death is quantified
Potency expressed as PFU/ml (number of infective particle units; plaque forming units) or TCID50

Question 20

potency of subunit viral vaccines

Answer 20

• Polysaccharide content,
• Polysaccharide size,
• Purity,
• Degree of adsorption (for vaccines that are adsorbed on aluminium)

Question 21

GMP: how to know whether companies are in compliance with legislation

Answer 21

• Compliance with GMP guidelines
• Full traceability
• Manufacturing and testing done as described in registration file
• Quality of raw materials: properly tested as described in registration file
• Properly validated analytical QC methods
• Results within acceptance limits for process controls