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J Pharm Sci. 2014 May;103(5):1315-30. doi: 10.1002/jps.23931. Epub 2014 Mar 12.

Impact of residual impurities and contaminants on protein stability.

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  • 1Pfizer Inc, Chesterfield, Missouri, 63017.


Production of recombinant proteins generates a variety of process-related impurities. The multistep manufacturing processes may introduce many potential contaminants into the final pharmaceutical products. These residual impurities and contaminants can potentially impact the protein stability significantly. In this short review, the authors intend to discuss major sources and types of residual process-related impurities and potential product contaminants, their impact on protein quality/stability, and possible mitigations during product development and manufacturing processes.

© 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.


biotechnology; deamidation; formulation; oxidation; protein aggregation

[PubMed - indexed for MEDLINE]
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