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Post-production handling and administration of protein pharmaceuticals and potential instability issues.

08:00 EDT 14th April 2018 | BioPortfolio

Summary of "Post-production handling and administration of protein pharmaceuticals and potential instability issues."

The safety and efficacy of protein pharmaceuticals depend not only on biological activity, but also on purity levels. Impurities may be process related due to limitations in manufacturing, or product related caused by protein degradation occurring throughout the life history of a product. Although the pharmaceutical biotechnology industry has made great progress in improving bulk and drug product manufacturing as well as company-controlled storage and transportation conditions to minimize the level of degradation, there is less control over the many factors that may subsequently affect product quality after the protein pharmaceuticals are released and shipped by the manufacturer. Routine handling or unintentional mishandling of therapeutic protein products may cause protein degradation that remains unnoticed but can potentially compromise the clinical safety and efficacy of the product. In this commentary we address some potential risks associated with (mis)handling of protein pharmaceuticals after release by the manufacturer. We summarize the environmental stress factors that have been shown to cause protein degradation and that may be encountered during typical handling procedures of protein pharmaceuticals in a hospital setting or during self-administration by patients. Moreover, we provide recommendations for improvements in product handling to help ensure the quality of protein pharmaceuticals during use.

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This article was published in the following journal.

Name: Journal of pharmaceutical sciences
ISSN: 1520-6017
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