Product Information
HISTORICAL
Location of the discovery of the yellow fever virus in 1927, the Institut Pasteur in Dakar yellow fever vaccine produced since the 1930s The vaccine is produced from the first strain isolated (French neurotropic strain) and is commonly called "vaccine French neurotropic "or" vaccine Dakar ". It is an attenuated live vaccine by successive passage of the virus on human mouse brain. Indeed in 1931 was made the first trial in humans by simultaneous injection of a suspension of the French strain and a certain amount of human immune serum whose role was to limit the potential virulence of the vaccine virus strain. In 1932 a second attempt was made of inoculating subcutaneously only modified French strain without the addition of serum.
This stable vaccine and perfectly adapted to the conditions of mass vaccination campaigns has been widely used to stop allowing many epidemics in Africa. From 1937 to 1983, nearly 192 million doses were produced and the Pasteur Institute of Dakar.
The development of a stable vaccine and better tolerated from Rockefeller 17D strain (strain isolated in 1927 in Ghana) has supplanted the "Dakar vaccine" in 1983.
The Institut Pasteur Dakar prepares since 1966 the anti-Amaril vaccine 17 D on chick embryos. The work of Professor BARME of the Pasteur Institute in Paris to improve the thermal stability of the vaccine prepared from 17D Rockefeller in 1982 gave it a boost.
Indeed a homemade preparation production in 1966 amounted to a globally recognized industrial level.
The production laboratory of yellow fever vaccine is currently one of the four laboratories around the world to have approval from the WHO to supply vaccine to the United Nations.
The packaging in ampoules 100 and 50 doses have been widely used in mass campaigns were abandoned in favor of packaging in ampoules of 5, 10 and 20 doses, flexible packaging for routine EPI vaccinations.
THE PRODUCTION
Production today
The production meets international standards for aseptic preparation of sterile vaccines.
This is a team qualified, efficient, competent
These are clean rooms, Zone of Controlled Atmosphere (A, B, C, D)
These are treated annually 100,000 eggs
Enabling the production of 10 million annual doses
Challenges and prospects
The preparation and the premises have evolved over time to the rhythm of normative requirements and quality assurance.
The Institut Pasteur in Dakar is accredited by WHO as UN supplier and therefore plays a decisive role in the global availability of this vaccine
The Institut Pasteur in Dakar is actively participating in tenders of the United Nations system of procurement (UNICEF, WHO ...)
The annual production capacity is currently about 10 million doses ampoule 5, 10 and 20 doses. Current requirements Anti-YF vaccine are well above the global production capacity.
The foundation Institut Pasteur in Dakar study a project to build new premises.
Such project will allow the foundation to have a powerful tool and increase its production capacity to enable it to respond to global demand
CONTROL
Quality control is part of good manufacturing practices; it concerns sampling, specifications, testing and the organizational procedures, documentation and release to ensure that the necessary and appropriate analyzes have actually been carried out and that raw materials, packaging items and products are not released for use, sale or supply without their quality has been judged satisfactory (GMP).
Control Process
The control of the manufacturing process is a critical issue and starts upon receipt of raw materials. This control ensures the quality assurance of raw materials used in the manufacturing process.
Control continues at intermediate stages (harvesting, vaccine bulk) and the finished product.
Packaging articles are also checked and approved before use.
These controls help ensure the quality of the product and its conformity to specifications and product folder before it is submitted to the competent authorities for approval.
Distribution operations are also subject to control.
The control of the working environment is part of the control laboratory activities and aims to ensure the conformity of the production areas to the activities carried out there.
Control is based on validated methods performed by a qualified, motivated and competent and qualified equipment and regular monitoring of a metrological point of view according to defined procedures.
Quality control meets international standards including the WHO standards and Good Manufacturing Practices in strengths.
The quality control laboratory participates in collaborative studies organized by the World Health Organization (WHO).