Journal article
Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues
Journal of pharmaceutical sciences, Vol.107(8), pp.2013-2019
08/2018
DOI: 10.1016/j.xphs.2018.04.005
PMID: 29665382
Abstract
The safety and efficacy of protein pharmaceuticals depend not only on biological activity but also on purity levels. Impurities may be process related because of limitations in manufacturing or product related because of 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.
Details
- Title: Subtitle
- Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues
- Creators
- M. Reza Nejadnik - Leiden UniversityTheodore W. Randolph - University of Colorado BoulderDavid B. Volkin - University of KansasChristian Schöneich - University of KansasJohn F. Carpenter - University of Colorado DenverDaan J.A. Crommelin - Utrecht UniversityWim Jiskoot - Centre for Human Drug Research
- Resource Type
- Journal article
- Publication Details
- Journal of pharmaceutical sciences, Vol.107(8), pp.2013-2019
- DOI
- 10.1016/j.xphs.2018.04.005
- PMID
- 29665382
- NLM abbreviation
- J Pharm Sci
- ISSN
- 0022-3549
- eISSN
- 1520-6017
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 08/2018
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984420937002771
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