IC11 PR3151 Flashcards
Levels of vaccine protection
1: individual
2: herd immunity (community)
3: global
4: future generations
Vaccine qualities
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
viral vector vaccine
process:
extract genetic material > insert into spike protein > injected and genetic material inserted into host cell > protein formed > antibodies created > vector virus broken down.
what are vaccine suspension fluids for?
to weaken the germ in the vaccines
what are examples and functions of vaccine preservatives
1) formaldehyde
2) phenoxyethanol
- easily eliminated and low toxicity
3) thiomersal
- bactericidal and fungicidal properties
what are examples and functions of vaccine adjuvants?
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)
what are vaccine adjuvants
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).
why are o/w and w/o emulsions adjuvants bad?
toxic and dangerous
what are examples and functions of vaccine stabilisers
msg: protect from heat light acidity humidity
gelatin: protect from heat
sorbitol: increases protein stability
buffers: adjust tonicity and osmolarity
what are examples of vaccine surfactants
LL M D SS
lecithin
lipopolysaccharide
mannide oleates
DDAB (ammonium…)
sorbitan Esther
saponines
what are the bioprocessing steps in vaccines manufacturing and the methods used for each
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
dry formulation administration methods
microneedle (intradermal –> pierce stratum corneum)
inhalation
reconstituted vaccine adminstration methods
inhalation
injection
filling process
lyophilisation
dissolve > 0.22nm > freeze dry > vacuum > heat > evaporate > complete stoppering
disadvantages of capping
1) trap moisture
2) lubrication (contaminant)
3) possible source of contamination (debris)
registration file review
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
quality control QC testing includes the following
ppigs
purity
potency (identity, size, integrity, purity)
identification
general parameters
safety (sterility, endotoxins)
examples of in vitro potency testing include:
1) Immuno assays via ELISA
IF fail
2) SDS PAGE (based on molecular weight)
3) SEC HPLC (Size exclusion chromatography, SEC)
potency of live viral vaccines
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
potency of subunit viral vaccines
- Polysaccharide content,
- Polysaccharide size,
- Purity,
- Degree of adsorption (for vaccines that are adsorbed on aluminium)
GMP: how to know whether companies are in compliance with legislation
- 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
