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PY367 Vaccines > Vaccine storage and handling > Flashcards

Vaccine storage and handling Flashcards

1
Q

what are the regulation guidelines on vaccines

A
  1. The committee for medicinal products for human use (CHMP)
  2. paediatric committee
  3. committee for advanced therapies
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2
Q

what is used in vaccine production

A
  1. clean rooms and laminar flow, positive pressure conditions
  2. sterile or virus segregation equipment
  3. segregation of personnel
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3
Q

describe the process of vaccine production

A
  1. microbe culture- optimise Ph and temperature
  2. harvest- remove pathogen
  3. purification of active- impurity removal, selection of species, process optimisation
  4. adjuvant preparation- activity destruction
  5. formulation of vaccine- sterility
    - antigen + adjuvant + preservative + stabiliser
  6. QA
  7. stability- testing and extreme cases
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4
Q

what is involved in growth in vaccine production

A
  1. virus grown on primary cells
  2. bacteria in bioreactors
  3. proteins or parts of the organism can be grown inside cells
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5
Q

what is used in inactivation

A

using agents and typically heat

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6
Q

what is used in purification

A

filtration, chromatography, centrifugation

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7
Q

what does the z value define

A

temperature

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8
Q

what does the d value define

A

number decrease at z value

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9
Q

what does F0 define

A

total effective sterilisation time

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10
Q

what sterilisation time is used for sterilisation of vaccines

A

sterilisation time/temperature for 6 mins
- used for vegetative cells
- spores
- denaturation of enzymes
- thermodestruction of macromolecules

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11
Q

what are the manufacturing needs for producing a vaccine

A
  1. manufacture- safety reviewed by CHMP, biological panels
  2. staff requirements- additional bio specific training, immunological status of staff
  3. in process controls
    - cGMP
    - finished goods purity, consistency and quality
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12
Q

describe the cold chain conditions

A
  1. has a maximum and a minimum
  2. clear effect of temperature on potency
  3. aim for 5 +/- 3 degrees storage in cold chain
  4. calibrate all refrigeration facilities
  5. cool box interim transfer systems- use bubblewrap insulants
  6. immunoglobulins can be stored at room temp for up to 1 week
  7. vaccines are sensitive to light, heat and freezing
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13
Q

describe the handling requirements of vaccines

A
  1. needs inventory management and emergency procedure
  2. all attempts to reduce wastage
  3. most vaccines damaged at freezing temperatures, producing agglomerates and precipitates
  4. data loggers and digital thermometers needed
  5. diluent are stored with vaccine so has to be temperature compatible and prevent precipitation or damage
  6. multi dose vaccines must be returned to fridge after required dose is withdrawn
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14
Q

describe the transportation requirements of vaccines

A
  1. ice pack, gel pack used for transport
  2. ice packs should be pre conditioned
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15
Q

outline the demands on manufacturing

A
  1. antigenic shift
  2. outbreaks
  3. changes to vaccination policy
  4. new social trends and travel habits
  5. downsizing, mergers and acquisitions
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16
Q

what is the difference between antigenic shift and drift

A
  1. shift- large change, subtype mixing and species mixing
  2. drift- small/subtle change, gene changes
17
Q

describe the antigenic evolution

A
  1. same strain, different virulence in new variant
    - new exposure
    - new transmission routes
    - movement across species
18
Q

what does out manoeuvring the antigenic drift mean

A

means producers must be able to quickly respond to seasonal and global new arrivals quickly

19
Q

where does antigenic swapping occur

A

inside an infected cell by RNA mixing to produce new strains
- antigenic shift
- eg. influenza A, B and C

20
Q

what does manufacture capability involve

A
  1. ability to respond quickly to potential pandemic
  2. respond to calls from health department
  3. ability for biologicals manufacturers to collaborate
  4. cold chain, and distribution systems to be effective
  5. quarantine procedure if needed
21
Q

give examples of reasons for vaccine shortages

A
  1. cold chain failures- Hep B most susceptible to freezing damage
  2. aggregation and degradation- poor storage
  3. higher than normal demand
  4. lack of resources

PY367 Vaccines (10 decks)

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