Document Detail


Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins.
MedLine Citation:
PMID:  23027660     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Adverse immune responses severely hamper the success of biopharmaceutical therapies. Possible clinical consequences include anaphylaxis, reduced drug half-life and neutralization of the therapeutic protein as well as the endogenous human homologue. Controlling potential triggers of the immune system helps to minimize the immunogenicity of biopharmaceuticals, a crucial consideration in biopharmaceutical manufacturing. This review summarizes the latest advancements that have been made towards insight into the impact of structural characteristics on the immunogenicity of therapeutic proteins. Examples are given to illustrate the role of critical quality attributes, such as protein conformation, glycosylation, chemical modifications and aggregation, in immunogenicity. During the development of biopharmaceutical products, it is important to not just assess the risk for immunogenicity in clinical trials, but to ensure product quality throughout drug design, cell-line selection, upstream and downstream processing, all the way to to the final product.
Authors:
Miranda M C van Beers; Muriel Bardor
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-2
Journal Detail:
Title:  Biotechnology journal     Volume:  -     ISSN:  1860-7314     ISO Abbreviation:  Biotechnol J     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101265833     Medline TA:  Biotechnol J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Affiliation:
Bioprocessing Technology Institute, Agency for Science, Technology and Research (A*STAR), Biopolis, Singapore. miranda_van_beers@bti.a-star.edu.sg.
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