Document Detail

Effect of polysorbate 80 concentration on thermal and photostability of a monoclonal antibody.
MedLine Citation:
PMID:  23152309     Owner:  NLM     Status:  MEDLINE    
Polysorbate 80 is widely used in protein formulations to protect protein against agitation-induced aggregation. In this study, we address concerns about residual peroxide present in Polysorbate 80 on protein stability. Residual peroxide may oxidize active pharmaceutical ingredients leading to reduced stability and may ultimately lead to lower potency and efficacy. The effect of Polysorbate 80 concentration on thermal and photostability of monoclonal antibody of the IgG1 subclass (MAb1) was evaluated at Polysorbate 80 concentrations ranging from 0.00% to 1.00% (w/v). MAb1 samples at 5 mg/mL with various Polysorbate 80 concentrations were subjected to accelerated thermal stress by incubation at 25°C, 40°C, and 50°C for a period of 4 weeks and light stress per ICH guideline Q1B, option 1. Our results show that Polysorbate 80 concentration of 1.00% (w/v) adversely affected thermal and photostability of MAb1. This study demonstrates the importance of carefully choosing Polysorbate 80 concentration in protein formulations to prevent destabilizing effect of Polysorbate 80 on thermal and photostability.
Meera Agarkhed; Courtney O'Dell; Ming-Ching Hsieh; Jingming Zhang; Joel Goldstein; Arvind Srivastava
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Publication Detail:
Type:  Journal Article     Date:  2012-11-14
Journal Detail:
Title:  AAPS PharmSciTech     Volume:  14     ISSN:  1530-9932     ISO Abbreviation:  AAPS PharmSciTech     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-26     Completed Date:  2013-08-12     Revised Date:  2013-12-04    
Medline Journal Info:
Nlm Unique ID:  100960111     Medline TA:  AAPS PharmSciTech     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1-9     Citation Subset:  IM    
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MeSH Terms
Antibodies, Monoclonal / chemistry*
Calorimetry, Differential Scanning
Chemistry, Pharmaceutical
Chromatography, Gel
Chromatography, Ion Exchange
Circular Dichroism
Hot Temperature
Peptide Mapping
Polysorbates / chemistry*
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Polysorbates

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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