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Quality Control of rDNA-Derived Human Tissue-Type Plasminogen Activator
Published in Anthony S. Lubiniecki, Large-Scale Mammalian Cell Culture Technology, 2018
Andrew J. S. Jones, Robert L. Carnick
The original concern over the use of nonhuman sources for the production of pharmaceuticals – in particular, the use of rDNA methods and continuous cell lines – was that these sources might contain nonhuman proteins. This could result in the production of antibodies to the foreign impurities leading to anaphylactic reactions and allergic manifestations similar to those observed in serum sickness. Products from rDNA technology using cell culture have therefore been expected to be of high purity to alleviate this concern. Residual cellular DNA is usually expressed in picograms per dose (see the following section) while protein purity is presented in terms of percent purity or relative impurity levels (11). Different degrees of purity may be acceptable if the useage of the therapeutic varies. Acceptable levels of residual cellular protein also should be considered on a per-dose basis (12). The approach developed for rt-PA included preparation of the product at a high level of purity to minimize the possibility of any adverse reaction to potential impurities.
A comprehensive summary of disease variants implicated in metal allergy
Published in Journal of Toxicology and Environmental Health, Part B, 2022
In type III hypersensitivity reactions (also called immune complex-mediated allergic reactions), host antibodies recognize and bind soluble antigen, forming a complex that may deposit within various tissues of the body, including blood vessel walls (Dispenza 2019). These complexes trigger complement activation, leading to local inflammation and tissue injury. Serum sickness and Arthus reactions constitute two of the most common manifestations of type III hypersensitivity reactions.