Quality Assurance for Biological Products

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A biological preparation that improves immunity to a particular disease is known as a vaccine. A vaccine contains an agent that would stimulate the body’s immune system. The immune system will recognize the agent as “foreign” and destroy it, once destroyed, the body will keep a record of it so the immune system can more easily recognize and destroy any of these microorganisms that it later encounters. The agent in the vaccine, resembling a disease-causing microorganism, is often made from a weakened or killed form of the microbe, toxin, or one of its surface proteins (6). Vaccines have no guarantee that it will bring complete protection for a disease. This is mainly because the host’s immune system simply does not respond enough, if not at all. The response could be due to factors such as age, or conditions such as diabetes or HIV. Another factor, because the host’s immune system may not have the B-cells that can generate antibodies to the specific antigen introduced by the vaccine. The production techniques of these vaccines are evolving along with delivery systems. However, the focus should be on the manufacturing of each individual vaccine that will go to different patients, so that each vaccine produced is safe and of high quality.
The process of producing a new vaccine involves many sequential steps. Each of these steps requires a certain amount of time to complete. Therefore, the process would need about five to six months for the first supplies of approved vaccine to become available (7). For example, vaccines for a new strain of virus (influenza) with pandemic potential become identified and isolated then manufactured into a vaccine. The vaccine development process for the influenza vaccine starts with obtaining a sample ...

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