Test 3 Commercial Production of Immunologics Flashcards
Categories of manufactured immunological products
- vaccines
- in vivo diagnostics
- immune sera
- human Ig
- human blood and blood products
- snake anit-venoms
- pollen extracts
vaccines
– Live vaccines
– Killed vaccines
– Toxoid vaccines
tetanus toxoid: workplace safety issues
- all steps of detoxification must occur in a completely isolated area with equipment reserved for that purpose
- everything must be disinfected before leaving area
- personnel entering or leaving unit must change clothing
tetanus toxoid: product sterility and safety issues
- high standards of worker hygiene
- sick workers must report their condition
- periodic health checks
- immunized against tetanus
tetanus toxoid: production
- cultivating pure C. tetani
- must produce minimum lethal dose by culture
- seed culture started -> large scale innoculation (150L) for 5-7 days
- filter produce
- add formaldehyde to detoxify it
- pH adjusted to 7.5, temp to 35C for 4 weeks, tested for toxicity
- if not toxic -> ultrafiltered
- adjuvant and preservative added
- dispensed into container
- post-production testing
What are examples of adjuvant? (of tetanus toxoid vaccine)
- aluminum hydroxide
- aluminum phosphate
What is an example of a preservative? (of tetanus toxoid vaccine)
thiomersal
How can you purify tetanus toxoid?
- concentrated by ultrafiltration
- purified by fractional salt precipitation
- salts removed and product is filter sterilized
What are examples of post-production testing? (of tetanus toxoid vaccine)
- sterility
- antigenicity
- toxin activity
antigenic shift
hybrid strain that didn’t exist before (more or less)
annual timeline for flu vaccine
- identify new virus
- prepare vaccine strain
- verify vaccine strain
- prepare reagents to test vaccine
- optimize virus growth conditions
- manufacture bulk vaccine
- quality control
- vaccine filling and release
- clinical trial
- review and release
Preparation of the vaccine strain (of flu vaccine)
- virus must first be adapted for use in manufacturing vaccine
- adapted to grow om hen’s eggs
Preparation of reagents to test the vaccine (of flu vaccine)
- WHO makes reference reagents
- Antigens purified from the human flu strain
- Reagents are given to vaccine manufacturers to measure their quantity
product in vaccine manufacturing (of flu vaccine)
- purified virus protein that is the antigen used for vaccination
- antigen: humagglutinin and neuraminidase
What is each batch tested for? (of flu vaccine)
- antigenicity
- sterility
- confirm protein concentration
- safety
