Vaccine production sterility tests

Use in the production of vaccines As assay organisms to determine antibiotic, vitamin and amino acid concentrations Quality control of immunological products Assay methods Sterilization methods Sterilization monitoring and validation procedures Sterility testing Assessment and calculation of sterility assurance Aseptic manufacture... 

Therefore quality control (QC) testing of vaccines normally includes the following assays, which must be passed prior to material being released for use in preclinical toxicology studies sterility, endotoxin, general safety, identity, mass, potency, purity, and stability [62], These assays should be performed on the final product using the clinical formulation. 

As listed in Table 3, quality of the vaccine must again be confirmed for bulk plasmids, for the formulated, and for the filled final product. Apart from routine tests for plasmid identity, purity, and sterility, consistency of the product and process must be demonstrated in at least three consecutive runs of the entire process. These runs must result in a product that meets all predefined specifications. Stability of DNA vaccines must be evaluated by long-term studies to demonstrate that the defined specifications are met until the end of the envisaged shelf live. For naked DNA, it is not anticipated that stability will be an issue. 

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