Vaccine storage and handling Flashcards
what are the regulation guidelines on vaccines
- The committee for medicinal products for human use (CHMP)
- paediatric committee
- committee for advanced therapies
what is used in vaccine production
- clean rooms and laminar flow, positive pressure conditions
- sterile or virus segregation equipment
- segregation of personnel
describe the process of vaccine production
- microbe culture- optimise Ph and temperature
- harvest- remove pathogen
- purification of active- impurity removal, selection of species, process optimisation
- adjuvant preparation- activity destruction
- formulation of vaccine- sterility
- antigen + adjuvant + preservative + stabiliser - QA
- stability- testing and extreme cases
what is involved in growth in vaccine production
- virus grown on primary cells
- bacteria in bioreactors
- proteins or parts of the organism can be grown inside cells
what is used in inactivation
using agents and typically heat
what is used in purification
filtration, chromatography, centrifugation
what does the z value define
temperature
what does the d value define
number decrease at z value
what does F0 define
total effective sterilisation time
what sterilisation time is used for sterilisation of vaccines
sterilisation time/temperature for 6 mins
- used for vegetative cells
- spores
- denaturation of enzymes
- thermodestruction of macromolecules
what are the manufacturing needs for producing a vaccine
- manufacture- safety reviewed by CHMP, biological panels
- staff requirements- additional bio specific training, immunological status of staff
- in process controls
- cGMP
- finished goods purity, consistency and quality
describe the cold chain conditions
- has a maximum and a minimum
- clear effect of temperature on potency
- aim for 5 +/- 3 degrees storage in cold chain
- calibrate all refrigeration facilities
- cool box interim transfer systems- use bubblewrap insulants
- immunoglobulins can be stored at room temp for up to 1 week
- vaccines are sensitive to light, heat and freezing
describe the handling requirements of vaccines
- needs inventory management and emergency procedure
- all attempts to reduce wastage
- most vaccines damaged at freezing temperatures, producing agglomerates and precipitates
- data loggers and digital thermometers needed
- diluent are stored with vaccine so has to be temperature compatible and prevent precipitation or damage
- multi dose vaccines must be returned to fridge after required dose is withdrawn
describe the transportation requirements of vaccines
- ice pack, gel pack used for transport
- ice packs should be pre conditioned
outline the demands on manufacturing
- antigenic shift
- outbreaks
- changes to vaccination policy
- new social trends and travel habits
- downsizing, mergers and acquisitions
what is the difference between antigenic shift and drift
- shift- large change, subtype mixing and species mixing
- drift- small/subtle change, gene changes
describe the antigenic evolution
- same strain, different virulence in new variant
- new exposure
- new transmission routes
- movement across species
what does out manoeuvring the antigenic drift mean
means producers must be able to quickly respond to seasonal and global new arrivals quickly
where does antigenic swapping occur
inside an infected cell by RNA mixing to produce new strains
- antigenic shift
- eg. influenza A, B and C
what does manufacture capability involve
- ability to respond quickly to potential pandemic
- respond to calls from health department
- ability for biologicals manufacturers to collaborate
- cold chain, and distribution systems to be effective
- quarantine procedure if needed
give examples of reasons for vaccine shortages
- cold chain failures- Hep B most susceptible to freezing damage
- aggregation and degradation- poor storage
- higher than normal demand
- lack of resources
