Document Detail


Chromatographic analysis of the acidic and basic species of recombinant monoclonal antibodies.
MedLine Citation:
PMID:  22820257     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The existence of multiple variants with differences in either charge, molecular weight or other properties is a common feature of monoclonal antibodies. These charge variants are generally referred to as acidic or basic compared with the main species. The chemical nature of the main species is usually well-understood, but understanding the chemical nature of acidic and basic species, and the differences between all three species, is critical for process development and formulation design. Complete understanding of acidic and basic species, however, is challenging because both species are known to contain multiple modifications, and it is likely that more modifications may be discovered. This review focuses on the current understanding of the modifications that can result in the generation of acidic and basic species and their affect on antibody structure, stability and biological functions. Chromatography elution profiles and several critical aspects regarding fraction collection and sample preparations necessary for detailed characterization are also discussed.
Authors:
Yi Du; Alison Walsh; Robin Ehrick; Wei Xu; Kimberly May; Hongcheng Liu
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Publication Detail:
Type:  Journal Article; Review     Date:  2012-07-23
Journal Detail:
Title:  mAbs     Volume:  4     ISSN:  1942-0870     ISO Abbreviation:  MAbs     Publication Date:    2012 Sep-Oct
Date Detail:
Created Date:  2012-09-07     Completed Date:  2013-01-17     Revised Date:  2013-09-03    
Medline Journal Info:
Nlm Unique ID:  101479829     Medline TA:  MAbs     Country:  United States    
Other Details:
Languages:  eng     Pagination:  578-85     Citation Subset:  IM    
Affiliation:
Merck Research Laboratories, Union, NJ, USA.
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MeSH Terms
Descriptor/Qualifier:
Amino Acid Sequence
Animals
Antibodies, Monoclonal / analysis,  chemistry*
Chromatography, Ion Exchange / methods*
Humans
Hydrogen-Ion Concentration
Mice
Protein Processing, Post-Translational
Recombinant Proteins / analysis,  chemistry*
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Recombinant Proteins
Comments/Corrections

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