Vaccine production process technology

In the preparation of classical killed or toxoid vaccines, simple process technology was used. With the advance of new vaccines, far more sophisticated process technologies are needed. The desire to reduce side effects of vaccination requires processes which will yield antigens of extreme purity. The new regulation in cGMP requires consistent production procedures, and global competition also demands that the most efficient process technology be appHed. 

The basic process technology in vaccine production consists of fermentation for the production of antigen, purification of antigen, and formulation of the final vaccine. In bacterial fermentation, technology is weU estabHshed. For viral vaccines, ceU culture is the standard procedure. Different variations of ceU line and process system are in use. For most of the Hve viral vaccine and other subunit vaccines, production is by direct infection of a ceU substrate with the vims. 

The skills and knowledge of those in all chentical and chentical engineering disciplines are needed for these processes. Additionally, collaboration among the disciplines must be cultivated—especially between researchers who synthesize new chenticals and materials and those who develop new processes to manufacture them. There must be parallel integration of fields, so that discoveries quickly lead to useful technology. In a terrorist attack, a quick response is essential, whether it be decontamination of a site or scale-up of drug or vaccine production. 

Recombinant DNA technology has allowed researchers to employ vastly different technologies to the process of vaccine production. 

Product extrinsic attributes 1. Source and history of milk and other inputs such as fodder, vaccination, type of cattle or buffalo, storage, handling and transportation conditions, etc. 2. Processing technology and resources used in production process of dairy products... 

The main areas in which freeze-drying is used can be found in the process technology applied in pharmacy, biology and medicine. A few examples of freeze-dried products are antibiotics, bacteria, sera, vaccines, diagnostic media, biotechnolog-ically produced products and foods. 

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