Vaccines Development Cycle
1
Quality: quality control, quality assurance Pharmacovigilance The vaccine development cycle Clinical development Between 9 and 14 years Up to 22 months RESEARCH & DEVELOPMENT INDUSTRIAL OPERATIONS Bulk production of a vaccine’s production time dedicated to quality control. Registration Product launch Exploratory stage Pre-clinical stage Phase I Phase II Phase III Germ culture Harvesting Purification Inactivation Valence assembly Formulation Filling Freeze-drying Packaging Batch release Transport 70% Average development time for a vaccine: 12 years Exploratory stage: 2 to 4 years Identifying antigens to prevent or treat a disease. Selected candidate vaccines will continue the process. Pre-clinical stage: 1 to 2 years Assessing antigens’ safety in animals and selecting the best candidate vaccine to continue the process. Clinical development: 6 to 8 years Testing the candidate vaccine in humans. Phase I: test of safety on 10 to 100 subjects Phase II: Evaluation of the immune response in 100 to 3,000 subjects Phase III: Large-scale tests of the vaccine’s efficacy and tolerance on 3,000 to 40,000 subjects. Registration: synthesis stage from 12 to 18 months All of the data that have been collected during the preceding stages are gathered in a file and submitted to the health authorities in order to obtain a marketing authorization. The infectious germs are cultured, harvested and purified. After formulation and freeze-drying (which stabilizes the more fragile vaccines), the vaccines are filled, primarily in vials and syringes and then packed. When the manufacturing process is complete, the cold chain must be constantly maintained during all stages, from distribution to vaccine administration to patients. Comments
-
Upload
irish-pharmaceutical-healthcare-association -
Category
Documents
-
view
214 -
download
0
description
Vaccine research is long, complex and costly. Because a vaccine is a biological product made from living microorganisms, its development cycle is quite different from that of a pharmaceutical product. (Courtesy of sanofi pasteur)
Transcript of Vaccines Development Cycle
Quality: quality control, quality assurance
Pharmacovigilance
The vaccine development cycle
Clinical development �
Between 9 and 14 years Up to 22 months �
RESEARCH & DEVELOPMENTINDUSTRIAL OPERATIONS
Bulk production
of a vaccine’s production time dedicated to quality control.
Registration �
Productlaunch
Exploratorystage
�
Pre-clinicalstage
�Phase I Phase II Phase III Germ
culture Harvesting Purification Inactivation Valenceassembly Formulation Filling Freeze-drying Packaging Batch
release Transport
70%Average development time for a vaccine: 12 years
� Exploratory stage: 2 to 4 yearsIdentifying antigens toprevent or treat a disease.Selected candidate vaccineswill continue the process.
� Pre-clinical stage: 1 to 2 yearsAssessing antigens’ safetyin animals and selecting the best candidate vaccineto continue the process.
� Clinical development: 6 to 8 yearsTesting the candidatevaccine in humans.Phase I: test of safetyon 10 to 100 subjects
Phase II: Evaluation of the immune response in 100 to 3,000 subjects
Phase III: Large-scale testsof the vaccine’s efficacyand tolerance on 3,000 to40,000 subjects.
� Registration: synthesis stage from 12 to 18 monthsAll of the data that havebeen collected during the preceding stages are gathered in a file
and submitted to thehealth authorities in order to obtain a marketing authorization.
� The infectious germs are cultured, harvested and purified. After formulation and freeze-drying (which stabilizes the more fragile vaccines),
the vaccines are filled,primarily in vials andsyringes and then packed.When the manufacturingprocess is complete, the cold chain must be constantly maintained
during all stages, fromdistribution to vaccineadministration to patients.
Comments
