Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling
Purpose The purpose of this study was to validate a ligand binding assay for the quantitation of a monoclonal antibody-based biotherapeutics (PF-57781346) in samples collected via capillary microsampling to support a regulated mouse toxicity study. Method A quantitative ligand binding assay on the G...
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| Veröffentlicht in: | Pharmaceutical research 2019-12, Vol.36 (12), p.1-8, Article 169 |
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| creator | Zhu, Liang Wang, Ying Joyce, Alison Djura, Ihor Gorovits, Boris |
| description | Purpose
The purpose of this study was to validate a ligand binding assay for the quantitation of a monoclonal antibody-based biotherapeutics (PF-57781346) in samples collected via capillary microsampling to support a regulated mouse toxicity study.
Method
A quantitative ligand binding assay on the Gyrolab platform was developed to quantify PF-57781346 in blood samples derived from capillary mouse serial sampling. The method validation evaluated assay characteristics including accuracy and precision, influence of sample processing on drug quantitation, whole blood matrix selectivity, dilution linearity and the stability of the drug in the study sample matrix.
Results
The method validation demonstrated acceptable analytical characteristics. The whole blood selectivity testing demonstrated accuracy between −4.8% and 13.9% in 10 out of 10 individual whole blood samples, suggesting that drug quantitation from whole blood is not impacted by the serial sampling procedure. Short-term and long-term drug stability in study sample matrix were established to cover required stability for sample storage and analysis (accuracy between −7.3% and 6.1%).
Conclusion
We reported a successful validation of a bioanalytical method that quantifies PF-55781346 in samples collected via capillary microsampling. The experience shared in this study could serve as a model process for bioanalytical method validation when capillary microsampling is used. |
| doi_str_mv | 10.1007/s11095-019-2699-z |
| format | Article |
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The purpose of this study was to validate a ligand binding assay for the quantitation of a monoclonal antibody-based biotherapeutics (PF-57781346) in samples collected via capillary microsampling to support a regulated mouse toxicity study.
Method
A quantitative ligand binding assay on the Gyrolab platform was developed to quantify PF-57781346 in blood samples derived from capillary mouse serial sampling. The method validation evaluated assay characteristics including accuracy and precision, influence of sample processing on drug quantitation, whole blood matrix selectivity, dilution linearity and the stability of the drug in the study sample matrix.
Results
The method validation demonstrated acceptable analytical characteristics. The whole blood selectivity testing demonstrated accuracy between −4.8% and 13.9% in 10 out of 10 individual whole blood samples, suggesting that drug quantitation from whole blood is not impacted by the serial sampling procedure. Short-term and long-term drug stability in study sample matrix were established to cover required stability for sample storage and analysis (accuracy between −7.3% and 6.1%).
Conclusion
We reported a successful validation of a bioanalytical method that quantifies PF-55781346 in samples collected via capillary microsampling. The experience shared in this study could serve as a model process for bioanalytical method validation when capillary microsampling is used.</description><identifier>ISSN: 0724-8741</identifier><identifier>EISSN: 1573-904X</identifier><identifier>DOI: 10.1007/s11095-019-2699-z</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Accuracy ; Analysis ; Assaying ; Biochemistry ; Biomedical and Life Sciences ; Biomedical Engineering and Bioengineering ; Biomedicine ; Blood ; Dilution ; Ethylenediaminetetraacetic acid ; Ligands ; Linearity ; Medical Law ; Monoclonal antibodies ; Pharmacology/Toxicology ; Pharmacy ; Quantitation ; Research Paper ; Sampling ; Selectivity ; Shelf life ; Toxicity</subject><ispartof>Pharmaceutical research, 2019-12, Vol.36 (12), p.1-8, Article 169</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2019</rights><rights>COPYRIGHT 2019 Springer</rights><rights>Pharmaceutical Research is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c416t-c2d097e16202598f43dbda03e2470de3818613ed0faa7026ec79ccb0b004df523</citedby><cites>FETCH-LOGICAL-c416t-c2d097e16202598f43dbda03e2470de3818613ed0faa7026ec79ccb0b004df523</cites><orcidid>0000-0001-7873-2015</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11095-019-2699-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11095-019-2699-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids></links><search><creatorcontrib>Zhu, Liang</creatorcontrib><creatorcontrib>Wang, Ying</creatorcontrib><creatorcontrib>Joyce, Alison</creatorcontrib><creatorcontrib>Djura, Ihor</creatorcontrib><creatorcontrib>Gorovits, Boris</creatorcontrib><title>Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling</title><title>Pharmaceutical research</title><addtitle>Pharm Res</addtitle><description>Purpose
The purpose of this study was to validate a ligand binding assay for the quantitation of a monoclonal antibody-based biotherapeutics (PF-57781346) in samples collected via capillary microsampling to support a regulated mouse toxicity study.
Method
A quantitative ligand binding assay on the Gyrolab platform was developed to quantify PF-57781346 in blood samples derived from capillary mouse serial sampling. The method validation evaluated assay characteristics including accuracy and precision, influence of sample processing on drug quantitation, whole blood matrix selectivity, dilution linearity and the stability of the drug in the study sample matrix.
Results
The method validation demonstrated acceptable analytical characteristics. The whole blood selectivity testing demonstrated accuracy between −4.8% and 13.9% in 10 out of 10 individual whole blood samples, suggesting that drug quantitation from whole blood is not impacted by the serial sampling procedure. Short-term and long-term drug stability in study sample matrix were established to cover required stability for sample storage and analysis (accuracy between −7.3% and 6.1%).
Conclusion
We reported a successful validation of a bioanalytical method that quantifies PF-55781346 in samples collected via capillary microsampling. The experience shared in this study could serve as a model process for bioanalytical method validation when capillary microsampling is used.</description><subject>Accuracy</subject><subject>Analysis</subject><subject>Assaying</subject><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedical Engineering and Bioengineering</subject><subject>Biomedicine</subject><subject>Blood</subject><subject>Dilution</subject><subject>Ethylenediaminetetraacetic acid</subject><subject>Ligands</subject><subject>Linearity</subject><subject>Medical Law</subject><subject>Monoclonal antibodies</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Quantitation</subject><subject>Research Paper</subject><subject>Sampling</subject><subject>Selectivity</subject><subject>Shelf life</subject><subject>Toxicity</subject><issn>0724-8741</issn><issn>1573-904X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kU-LFDEQxYMoOK5-AG8BL16yW0n3dDrHcXFVGFGYXfEWMvkzZu1JxqQbdvbTW83IiqLkUFD8XuXxHiEvOZxzAHlROQe1ZMAVE51S7P4RWfClbJiC9utjsgApWtbLlj8lz2q9BYCeq3ZBvl3FkYVc2OepHHL19IsZojNjzInmQA1dx51Jjr6JycW0o6tazZGigF7nu2jz95j8GC3djJM70ps6Mx_zhIc2vkQz0I3ZHwbcPidPghmqf_FrnpGbq7fXl-_Z-tO7D5erNbMt70ZmhQMlPe8EiKXqQ9u4rTPQeNFKcL7ped_xxjsIxkgQnbdSWbuFLUDrwlI0Z-T16e6h5B-Tr6Pex2r9MJjk0ZcWDeYEoBpA9NVf6G2eSkJ3M9VL_Am5B2pnBq9jCnksxs5H9QpDFSAxYqTO_0Hhc36PMSUfIu7_EPCTwJZca_FBH0rcm3LUHPRcqT5VqrFSPVeq71EjTpqKbNr58tvw_0U_AY0-ol4</recordid><startdate>20191201</startdate><enddate>20191201</enddate><creator>Zhu, Liang</creator><creator>Wang, Ying</creator><creator>Joyce, Alison</creator><creator>Djura, Ihor</creator><creator>Gorovits, Boris</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7873-2015</orcidid></search><sort><creationdate>20191201</creationdate><title>Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling</title><author>Zhu, Liang ; Wang, Ying ; Joyce, Alison ; Djura, Ihor ; Gorovits, Boris</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c416t-c2d097e16202598f43dbda03e2470de3818613ed0faa7026ec79ccb0b004df523</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Accuracy</topic><topic>Analysis</topic><topic>Assaying</topic><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedical Engineering and Bioengineering</topic><topic>Biomedicine</topic><topic>Blood</topic><topic>Dilution</topic><topic>Ethylenediaminetetraacetic acid</topic><topic>Ligands</topic><topic>Linearity</topic><topic>Medical Law</topic><topic>Monoclonal antibodies</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Quantitation</topic><topic>Research Paper</topic><topic>Sampling</topic><topic>Selectivity</topic><topic>Shelf life</topic><topic>Toxicity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhu, Liang</creatorcontrib><creatorcontrib>Wang, Ying</creatorcontrib><creatorcontrib>Joyce, Alison</creatorcontrib><creatorcontrib>Djura, Ihor</creatorcontrib><creatorcontrib>Gorovits, Boris</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmaceutical research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhu, Liang</au><au>Wang, Ying</au><au>Joyce, Alison</au><au>Djura, Ihor</au><au>Gorovits, Boris</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling</atitle><jtitle>Pharmaceutical research</jtitle><stitle>Pharm Res</stitle><date>2019-12-01</date><risdate>2019</risdate><volume>36</volume><issue>12</issue><spage>1</spage><epage>8</epage><pages>1-8</pages><artnum>169</artnum><issn>0724-8741</issn><eissn>1573-904X</eissn><abstract>Purpose
The purpose of this study was to validate a ligand binding assay for the quantitation of a monoclonal antibody-based biotherapeutics (PF-57781346) in samples collected via capillary microsampling to support a regulated mouse toxicity study.
Method
A quantitative ligand binding assay on the Gyrolab platform was developed to quantify PF-57781346 in blood samples derived from capillary mouse serial sampling. The method validation evaluated assay characteristics including accuracy and precision, influence of sample processing on drug quantitation, whole blood matrix selectivity, dilution linearity and the stability of the drug in the study sample matrix.
Results
The method validation demonstrated acceptable analytical characteristics. The whole blood selectivity testing demonstrated accuracy between −4.8% and 13.9% in 10 out of 10 individual whole blood samples, suggesting that drug quantitation from whole blood is not impacted by the serial sampling procedure. Short-term and long-term drug stability in study sample matrix were established to cover required stability for sample storage and analysis (accuracy between −7.3% and 6.1%).
Conclusion
We reported a successful validation of a bioanalytical method that quantifies PF-55781346 in samples collected via capillary microsampling. The experience shared in this study could serve as a model process for bioanalytical method validation when capillary microsampling is used.</abstract><cop>New York</cop><pub>Springer US</pub><doi>10.1007/s11095-019-2699-z</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-7873-2015</orcidid></addata></record> |
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| subjects | Accuracy Analysis Assaying Biochemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Blood Dilution Ethylenediaminetetraacetic acid Ligands Linearity Medical Law Monoclonal antibodies Pharmacology/Toxicology Pharmacy Quantitation Research Paper Sampling Selectivity Shelf life Toxicity |
| title | Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling |
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