期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 105, 期 2, 页码 417-430出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2015.11.002
关键词
immune response; physicochemical properties; protein aggregation; proteins; regulatory science
资金
- U.S. FDA [HHSF223201310233C]
- NIH [R01GM085293]
- Purdue University
Therapeutic proteins have a propensity for aggregation during manufacturing, shipping, and storage. The presence of aggregates in protein drug products can induce adverse immune responses in patients that may affect safety and efficacy, and so it is of concern to both manufacturers and regulatory agencies. In this vein, there is a lack of understanding of the physicochemical determinants of immunological responses and a lack of standardized analytical methods to survey the molecular properties of aggregates associated with immune activation. In this review, we provide an overview of the basic immune mechanisms in the context of interactions with protein aggregates. We then critically examine the literature with emphasis on the underlying immune mechanisms as they relate to aggregate properties. Finally, we highlight the gaps in our current understanding of this issue and offer recommendations for future research. (C) 2016 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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