Bacterial Endotoxins As Contaminants Of Therapeutic Proteins

Source: FUJIFILM Wako Chemicals U.S.A. Corp.
Bacterial Endotoxins As Contaminants Of Therapeutic Proteins

The purity of a protein to be used for therapeutic purposes is of vital importance. In terms of the evidence necessary to determine whether a protein will be viable as a medicine, it is essential that the protein has a high degree of purity and that it does not cause unwanted immune reactions in organisms where pre-use tests are performed. The impurities of a therapeutic protein might be similar molecules obtained as part of the protein biosynthesis, or might come from the cellular substrate used in its production or from the production process itself. It is necessary to study the types of contaminants that are present in any protein formulation to be used for medical purposes since these contaminants can alter both the response profile to the active substance and the results of the toxicity tests.

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