Vaccine production final product control

The quality control of both diphtheria and tetanus vaccines requires that the products are tested for the presence of free toxin, that is for specific toxicity due to inadequate detoxification with formalin, at the final-product stage. By this stage, however, the toxoid concentrates used in the preparation of the vaccines have been much diluted and, as the volume ofvaccine that can be inoculated into the test animals (guinea-pigs)... 

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. 

In this respect, rDNA products are considered to be similar to biologicals produced by traditional methods, such as bacterial and viral vaccines, where adequate control of the starting materials and manufacturing procedure is just as necessary as that of the product. The guidelines therefore place considerable emphasis on in-process controls for ensuring the safety and effectiveness of the product, as well as on the comprehensive characterization of the final product itself. The validation of certain aspects of the manufacturing process, such as the ability of the purification procedure to remove unwanted materials, e.g., DNA, is also considered to be essential. 

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