Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10162341 | Journal of Pharmaceutical Sciences | 2014 | 16 Pages |
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. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.
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Authors
Wei Wang, Arun Alphonse Ignatius, Santosh V. Thakkar,