PubTransformer

A site to transform Pubmed publications into these bibliographic reference formats: ADS, BibTeX, EndNote, ISI used by the Web of Knowledge, RIS, MEDLINE, Microsoft's Word 2007 XML.

Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.

Abstract Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.
PMID
Related Publications

Fluorescent molecular rotors as dyes to characterize polysorbate-containing IgG formulations.

Determination of polysorbate 80 in parenteral formulations by high-performance liquid chromatography and evaporative light scattering detection.

Quantitative determination of polysorbate 20 in nasal pharmaceutical preparations by high-performance liquid chromatography.

Towards absolute quantification of therapeutic monoclonal antibody in serum by LC-MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry.

A simple reversed phase high-performance liquid chromatography method for polysorbate 80 quantitation in monoclonal antibody drug products.

Authors

Mayor MeshTerms
Keywords

bis-ANS

fluorescence emission

high throughput

monoclonal antibody (mAb)

polysorbate-80 assay

surfactant

Journal Title pharmaceutical development and technology
Publication Year Start
%A Zheng, Songyan; Smith, Pedro; Burton, Lori; Adams, Monica L.
%T Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.
%J Pharmaceutical development and technology, pp. 1-5
%D 06/2014
%M ENG
%B Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.
%P 1
%L 5
%Y 10.3109/10837450.2014.930490
%W PHY
%G AUTHOR
%R 2014.............1Z

@Article{Zheng2014,
author="Zheng, Songyan
and Smith, Pedro
and Burton, Lori
and Adams, Monica L.",
title="Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.",
journal="Pharmaceutical development and technology",
year="2014",
month="Jun",
day="20",
pages="1--5",
abstract="Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.",
issn="1097-9867",
doi="10.3109/10837450.2014.930490",
url="http://www.ncbi.nlm.nih.gov/pubmed/24946793",
language="ENG"
}

%0 Journal Article
%T Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.
%A Zheng, Songyan
%A Smith, Pedro
%A Burton, Lori
%A Adams, Monica L.
%J Pharmaceutical development and technology
%D 2014
%8 Jun 20
%@ 1097-9867
%G ENG
%F Zheng2014
%X Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.
%U http://dx.doi.org/10.3109/10837450.2014.930490
%U http://www.ncbi.nlm.nih.gov/pubmed/24946793
%P 1-5

PT Journal
AU Zheng, S
   Smith, P
   Burton, L
   Adams, ML
TI Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.
SO Pharmaceutical development and technology
JI Pharm Dev Technol
PD Jun
PY 2014
BP 1
EP 5
DI 10.3109/10837450.2014.930490
LA ENG
AB Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.
ER

PMID- 24946793
OWN - NLM
STAT- Publisher
DA  - 20140620
IS  - 1097-9867 (Electronic)
IS  - 1083-7450 (Linking)
DP  - 2014 Jun 20
TI  - Sensitive fluorescence-based method for the rapid determination of polysorbate-80
      content in therapeutic monoclonal antibody products.
PG  - 1-5
AB  - Abstract A sensitive and effective method has been developed for the rapid
      determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) 
      products. The method is based on the detection of the fluorescence emission of
      4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS)
      enhanced by the presence of polysorbate-80. The developed method includes two
      approaches. One requires removal of the mAb from solution prior to analysis,
      while the other requires only simple sample dilution. The limits of detection and
      quantitation, calculated from the calibration curve generated in the absence of
      mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable
      linear range and linearity of the linear line between the solutions, with or
      without mAb, the limit of detection and quantitation is assumed to be similar.
      The dilution method is not only fast and simple in terms of sample preparation,
      but it is also particularly useful for analyzing the level of polysorbate-80
      contained in highly concentrated mAb products. However, given that this method
      does require availability of polysorbate-80-free materials of mAb for preparation
      of calibration standards, the protein removal method may be useful for the cases 
      where appropriate protein materials for standard preparation are limited or
      unavailable.
FAU - Zheng, Songyan
AU  - Zheng S
AD  - Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick, NJ ,
      USA.
FAU - Smith, Pedro
AU  - Smith P
FAU - Burton, Lori
AU  - Burton L
FAU - Adams, Monica L
AU  - Adams ML
LA  - ENG
PT  - JOURNAL ARTICLE
DEP - 20140620
TA  - Pharm Dev Technol
JT  - Pharmaceutical development and technology
JID - 9610932
OTO - NOTNLM
OT  - bis-ANS
OT  - fluorescence emission
OT  - high throughput
OT  - monoclonal antibody (mAb)
OT  - polysorbate-80 assay
OT  - surfactant
EDAT- 2014/06/21 06:00
MHDA- 2014/06/21 06:00
CRDT- 2014/06/21 06:00
AID - 10.3109/10837450.2014.930490 [doi]
PST - aheadofprint
SO  - Pharm Dev Technol. 2014 Jun 20:1-5.
TY  - JOUR
AU  - Zheng, Songyan
AU  - Smith, Pedro
AU  - Burton, Lori
AU  - Adams, Monica L.
PY  - 2014/Jun/20
TI  - Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.
T2  - Pharm Dev Technol
JO  - Pharmaceutical development and technology
SP  - 1
EP  - 5
N2  - Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4'-dianilino-1,1'-binaphthyl-5,5'-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.
SN  - 1097-9867
UR  - http://dx.doi.org/10.3109/10837450.2014.930490
UR  - http://www.ncbi.nlm.nih.gov/pubmed/24946793
ID  - Zheng2014
ER  - 
<?xml version="1.0" encoding="UTF-8"?>
<b:Sources SelectedStyle="" xmlns:b="http://schemas.openxmlformats.org/officeDocument/2006/bibliography"  xmlns="http://schemas.openxmlformats.org/officeDocument/2006/bibliography" >
<b:Source>
<b:Tag>Zheng2014</b:Tag>
<b:SourceType>ArticleInAPeriodical</b:SourceType>
<b:Year>2014</b:Year>
<b:Month>Jun</b:Month>
<b:Day>20</b:Day>
<b:PeriodicalName>Pharmaceutical development and technology</b:PeriodicalName>
<b:Pages>1-5</b:Pages>
<b:Author>
<b:Author><b:NameList>
<b:Person><b:Last>Zheng</b:Last><b:First>Songyan</b:First></b:Person>
<b:Person><b:Last>Smith</b:Last><b:First>Pedro</b:First></b:Person>
<b:Person><b:Last>Burton</b:Last><b:First>Lori</b:First></b:Person>
<b:Person><b:Last>Adams</b:Last><b:First>Monica</b:First><b:Middle>L</b:Middle></b:Person>
</b:NameList></b:Author>
</b:Author>
<b:Title>Sensitive fluorescence-based method for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody products.</b:Title>
 <b:ShortTitle>Pharm Dev Technol</b:ShortTitle>
<b:Comments>Abstract A sensitive and effective method has been developed for the rapid determination of polysorbate-80 content in therapeutic monoclonal antibody (mAb) products. The method is based on the detection of the fluorescence emission of 4,4&apos;-dianilino-1,1&apos;-binaphthyl-5,5&apos;-disulfonic acid dipotassium salt (bis-ANS) enhanced by the presence of polysorbate-80. The developed method includes two approaches. One requires removal of the mAb from solution prior to analysis, while the other requires only simple sample dilution. The limits of detection and quantitation, calculated from the calibration curve generated in the absence of mAb-A, were 1.5 and 4.7 parts per million, respectively. Given the comparable linear range and linearity of the linear line between the solutions, with or without mAb, the limit of detection and quantitation is assumed to be similar. The dilution method is not only fast and simple in terms of sample preparation, but it is also particularly useful for analyzing the level of polysorbate-80 contained in highly concentrated mAb products. However, given that this method does require availability of polysorbate-80-free materials of mAb for preparation of calibration standards, the protein removal method may be useful for the cases where appropriate protein materials for standard preparation are limited or unavailable.</b:Comments>
</b:Source>
</b:Sources>