The function of a vaccine is to enable the body's immune system to fight and defend against a disease.
When a vaccine is injected into the body, the immune system detects the pieces of virus or the killed/weakened virus (also known as the antigen) in the vaccine as a foreign invader and starts an immune response by producing proteins called antibodies which then neutralizes these foreign viruses or viral particles. If the body comes in contact with the same virus in the future, the immune system responds rapidly to prevent the development of the disease.
There are different manufacturing methods to produce vaccine antigens, the substance that triggers an immune response in the human body to produce antibodies.
Seasonal flu vaccines are traditionally manufactured using fertilized embryonic eggs. This method takes about four months to produce a batch of vaccines for each new strain of the virus.The safety and effectiveness of the vaccines produced using embryonic eggs are well established.
In the 1990s, vaccine manufacturing methods were developed using cells from mammals to culture the virus for vaccine production. Various pharmaceutical companies use different sources of mammalian cell cultures for the vaccine production.
Vaccine manufacturing is one of the most challenging industries, typically taking 6-36 months. The goal of the vaccine manufacturer is to produce vaccines in a manner that is safe, effective, and consistent over the life cycle of the vaccine while reducing costs of development, construction and operation of manufacturing facilities and complying with local and international regulations.
While the sequence of operations, the specific cycles for each product and filling and lyophilization equipment may vary, there are common equipment across platforms such as bioreactors, filtration and chromatography equipment. However, any significant changes in the manufacturing process, such as new facilities, new processes, manufacturing equipment or changes in raw materials typically trigger new regulatory requirements, including clinical trials.
Cell culture ►
Cell line development
Cell culture expansion
Perfusion cell culture
Virus inoculation ►
Tangential flow filtration
Virus inactivation ►
Tangential Flow Filtration (TFF)
Concentration and Diafiltration
Fill / Finish
The major goals of veterinary vaccines are to improve the health and welfare of companion animals, increase the production of livestock in a cost-effective manner and prevent animal-to-human transmission from both wild and domestic animals. The process for the production of veterinary vaccines is similar to the process for developing and manufacturing vaccines for human use.