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- Title
Impact of residual impurities and contaminants on protein stability.
- Authors
Wang, Wei; Ignatius, Arun Alphonse; Thakkar, Santosh V
- Abstract
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.
- Publication
Journal of pharmaceutical sciences, 2014, Vol 103, Issue 5, p1315
- ISSN
1520-6017
- Publication type
Journal Article
- DOI
10.1002/jps.23931