Qualitative and quantitative studies on human B7.1-Fc fusion protein and the application in pharmacokinetic study in rhesus monkeys
A sensitive, accurate, and precise enzyme immunoassay (EIA) for the quantification of intact human B7.1-Fc in rhesus monkey serum was validated, and the characteristics of B7.1 and Fc moiety of fusion protein were identified by surface plasmon resonance (SPR) and flow-cytometric method, respectively...
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| Veröffentlicht in: | Journal of pharmaceutical and biomedical analysis 2011-01, Vol.54 (1), p.133-140 |
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| creator | Chen, Zhihang Liu, Ruorui Che, Jinjing Shi, Hongjiao Hou, Yunan Liu, Yunlong Sun, Lili Tan, Li Shan, Chengqi Hu, Peisheng Cheng, Yuanguo |
| description | A sensitive, accurate, and precise enzyme immunoassay (EIA) for the quantification of intact human B7.1-Fc in rhesus monkey serum was validated, and the characteristics of B7.1 and Fc moiety of fusion protein were identified by surface plasmon resonance (SPR) and flow-cytometric method, respectively. B7.1-Fc bound to CD28 and CTLA-4 with
K
d values of 45.1 and 9.58
nM, respectively, which were very closed to the previous reports and the function of Fc moiety of fusion protein was also confirmed by Fc receptor binding assay and IL-8 releasing assay. To monitor the intact protein, the EIA method employed a sandwich scheme in which a multiclonal anti-human IgG (Fc specific) antibody and a monoclonal anti-human B7.1 antibody were served as capture and detection antibody, respectively. This EIA has a range of reliable response of 0.5–32
ng/ml. The LLOQ was established at 0.5
ng/ml. The intra-assay precision and accuracy were 6.1–8.8% and (3.0–9.0)%, respectively with the inter-assay precision and accuracy were 5.7–11.5% and (10.7–9.1)%, respectively. Stability was established under certain conditions and no significant differences were found. This validated EIA assay was then successfully employed in the assessment of pharmacokinetic behavior of B7.1-Fc in rhesus monkeys after intravenous infusion, and a non-linear characteristics was established across the investigated dosage range (32–320
μg/kg). |
| doi_str_mv | 10.1016/j.jpba.2010.07.040 |
| format | Article |
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K
d values of 45.1 and 9.58
nM, respectively, which were very closed to the previous reports and the function of Fc moiety of fusion protein was also confirmed by Fc receptor binding assay and IL-8 releasing assay. To monitor the intact protein, the EIA method employed a sandwich scheme in which a multiclonal anti-human IgG (Fc specific) antibody and a monoclonal anti-human B7.1 antibody were served as capture and detection antibody, respectively. This EIA has a range of reliable response of 0.5–32
ng/ml. The LLOQ was established at 0.5
ng/ml. The intra-assay precision and accuracy were 6.1–8.8% and (3.0–9.0)%, respectively with the inter-assay precision and accuracy were 5.7–11.5% and (10.7–9.1)%, respectively. Stability was established under certain conditions and no significant differences were found. This validated EIA assay was then successfully employed in the assessment of pharmacokinetic behavior of B7.1-Fc in rhesus monkeys after intravenous infusion, and a non-linear characteristics was established across the investigated dosage range (32–320
μg/kg).</description><identifier>ISSN: 0731-7085</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/j.jpba.2010.07.040</identifier><identifier>PMID: 20801597</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Analysis ; Analytical, structural and metabolic biochemistry ; Animals ; Antibodies, Monoclonal - chemistry ; Antibody Affinity ; antibody detection ; Antigens, CD - chemistry ; B7-1 Antigen - chemistry ; B7.1-Fc ; Biological and medical sciences ; blood serum ; CD28 Antigens - chemistry ; Chemistry, Pharmaceutical - methods ; CTLA-4 Antigen ; Enzyme immunoassay ; enzyme immunoassays ; Flow cytometry ; Fundamental and applied biological sciences. Psychology ; General pharmacology ; Humans ; Immunoenzyme Techniques - methods ; Immunoglobulin Fc Fragments - chemistry ; immunoglobulin G ; interleukin-8 ; Interleukin-8 - metabolism ; intravenous injection ; Kinetics ; Macaca mulatta ; Medical sciences ; Mice ; monoclonal antibodies ; Pharmacokinetics ; Pharmacology. Drug treatments ; Reproducibility of Results ; Surface plasmon resonance</subject><ispartof>Journal of pharmaceutical and biomedical analysis, 2011-01, Vol.54 (1), p.133-140</ispartof><rights>2010 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2010 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c409t-5deffba4cd125ffd47a4f32ff58d7046574fc54a47c49529908835ea7948780b3</citedby><cites>FETCH-LOGICAL-c409t-5deffba4cd125ffd47a4f32ff58d7046574fc54a47c49529908835ea7948780b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpba.2010.07.040$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23310707$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20801597$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Zhihang</creatorcontrib><creatorcontrib>Liu, Ruorui</creatorcontrib><creatorcontrib>Che, Jinjing</creatorcontrib><creatorcontrib>Shi, Hongjiao</creatorcontrib><creatorcontrib>Hou, Yunan</creatorcontrib><creatorcontrib>Liu, Yunlong</creatorcontrib><creatorcontrib>Sun, Lili</creatorcontrib><creatorcontrib>Tan, Li</creatorcontrib><creatorcontrib>Shan, Chengqi</creatorcontrib><creatorcontrib>Hu, Peisheng</creatorcontrib><creatorcontrib>Cheng, Yuanguo</creatorcontrib><title>Qualitative and quantitative studies on human B7.1-Fc fusion protein and the application in pharmacokinetic study in rhesus monkeys</title><title>Journal of pharmaceutical and biomedical analysis</title><addtitle>J Pharm Biomed Anal</addtitle><description>A sensitive, accurate, and precise enzyme immunoassay (EIA) for the quantification of intact human B7.1-Fc in rhesus monkey serum was validated, and the characteristics of B7.1 and Fc moiety of fusion protein were identified by surface plasmon resonance (SPR) and flow-cytometric method, respectively. B7.1-Fc bound to CD28 and CTLA-4 with
K
d values of 45.1 and 9.58
nM, respectively, which were very closed to the previous reports and the function of Fc moiety of fusion protein was also confirmed by Fc receptor binding assay and IL-8 releasing assay. To monitor the intact protein, the EIA method employed a sandwich scheme in which a multiclonal anti-human IgG (Fc specific) antibody and a monoclonal anti-human B7.1 antibody were served as capture and detection antibody, respectively. This EIA has a range of reliable response of 0.5–32
ng/ml. The LLOQ was established at 0.5
ng/ml. The intra-assay precision and accuracy were 6.1–8.8% and (3.0–9.0)%, respectively with the inter-assay precision and accuracy were 5.7–11.5% and (10.7–9.1)%, respectively. Stability was established under certain conditions and no significant differences were found. This validated EIA assay was then successfully employed in the assessment of pharmacokinetic behavior of B7.1-Fc in rhesus monkeys after intravenous infusion, and a non-linear characteristics was established across the investigated dosage range (32–320
μg/kg).</description><subject>Analysis</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Animals</subject><subject>Antibodies, Monoclonal - chemistry</subject><subject>Antibody Affinity</subject><subject>antibody detection</subject><subject>Antigens, CD - chemistry</subject><subject>B7-1 Antigen - chemistry</subject><subject>B7.1-Fc</subject><subject>Biological and medical sciences</subject><subject>blood serum</subject><subject>CD28 Antigens - chemistry</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>CTLA-4 Antigen</subject><subject>Enzyme immunoassay</subject><subject>enzyme immunoassays</subject><subject>Flow cytometry</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Immunoenzyme Techniques - methods</subject><subject>Immunoglobulin Fc Fragments - chemistry</subject><subject>immunoglobulin G</subject><subject>interleukin-8</subject><subject>Interleukin-8 - metabolism</subject><subject>intravenous injection</subject><subject>Kinetics</subject><subject>Macaca mulatta</subject><subject>Medical sciences</subject><subject>Mice</subject><subject>monoclonal antibodies</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Reproducibility of Results</subject><subject>Surface plasmon resonance</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE9v1DAQxS0EotvCF-AAuSBOCePEXicSl1JRQKqEEFTiZs06Nutt4qT-U2nPfPE63S3cOI305vfejB4hryhUFOj6_a7azRusasgCiAoYPCEr2oqmrNfs11OyAtHQUkDLT8hpCDsA4LRjz8lJDS1Q3okV-fM94WAjRnunC3R9cZvQxUchxNRbHYrJFds0ois-ioqWl6owKdgszn6K2roHY9zmgHkerMrevMvyvEU_oppurNPRqoe4_bLwWx1SKMbJ3eh9eEGeGRyCfnmcZ-T68tPPiy_l1bfPXy_Or0rFoIsl77UxG2SqpzU3pmcCmWlqY3jbC2BrLphRnCETinW87jpo24ZrFB1rRQub5oy8O-Tmt2-TDlGONig9DOj0lIIUnDMAwepM1gdS-SkEr42cvR3R7yUFuXQvd3LpXi7dSxAyd59Nr4_xaTPq_q_lsewMvD0CGBQOxqNTNvzjmoaCgIV7c-AMThJ_-8xc_8iXOACtoeHLqQ8HQue67qz2MiirndK99VpF2U_2f5_eA8zTrSw</recordid><startdate>201101</startdate><enddate>201101</enddate><creator>Chen, Zhihang</creator><creator>Liu, Ruorui</creator><creator>Che, Jinjing</creator><creator>Shi, Hongjiao</creator><creator>Hou, Yunan</creator><creator>Liu, Yunlong</creator><creator>Sun, Lili</creator><creator>Tan, Li</creator><creator>Shan, Chengqi</creator><creator>Hu, Peisheng</creator><creator>Cheng, Yuanguo</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201101</creationdate><title>Qualitative and quantitative studies on human B7.1-Fc fusion protein and the application in pharmacokinetic study in rhesus monkeys</title><author>Chen, Zhihang ; Liu, Ruorui ; Che, Jinjing ; Shi, Hongjiao ; Hou, Yunan ; Liu, Yunlong ; Sun, Lili ; Tan, Li ; Shan, Chengqi ; Hu, Peisheng ; Cheng, Yuanguo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-5deffba4cd125ffd47a4f32ff58d7046574fc54a47c49529908835ea7948780b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Analysis</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Animals</topic><topic>Antibodies, Monoclonal - chemistry</topic><topic>Antibody Affinity</topic><topic>antibody detection</topic><topic>Antigens, CD - chemistry</topic><topic>B7-1 Antigen - chemistry</topic><topic>B7.1-Fc</topic><topic>Biological and medical sciences</topic><topic>blood serum</topic><topic>CD28 Antigens - chemistry</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>CTLA-4 Antigen</topic><topic>Enzyme immunoassay</topic><topic>enzyme immunoassays</topic><topic>Flow cytometry</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Immunoenzyme Techniques - methods</topic><topic>Immunoglobulin Fc Fragments - chemistry</topic><topic>immunoglobulin G</topic><topic>interleukin-8</topic><topic>Interleukin-8 - metabolism</topic><topic>intravenous injection</topic><topic>Kinetics</topic><topic>Macaca mulatta</topic><topic>Medical sciences</topic><topic>Mice</topic><topic>monoclonal antibodies</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Reproducibility of Results</topic><topic>Surface plasmon resonance</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chen, Zhihang</creatorcontrib><creatorcontrib>Liu, Ruorui</creatorcontrib><creatorcontrib>Che, Jinjing</creatorcontrib><creatorcontrib>Shi, Hongjiao</creatorcontrib><creatorcontrib>Hou, Yunan</creatorcontrib><creatorcontrib>Liu, Yunlong</creatorcontrib><creatorcontrib>Sun, Lili</creatorcontrib><creatorcontrib>Tan, Li</creatorcontrib><creatorcontrib>Shan, Chengqi</creatorcontrib><creatorcontrib>Hu, Peisheng</creatorcontrib><creatorcontrib>Cheng, Yuanguo</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Zhihang</au><au>Liu, Ruorui</au><au>Che, Jinjing</au><au>Shi, Hongjiao</au><au>Hou, Yunan</au><au>Liu, Yunlong</au><au>Sun, Lili</au><au>Tan, Li</au><au>Shan, Chengqi</au><au>Hu, Peisheng</au><au>Cheng, Yuanguo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Qualitative and quantitative studies on human B7.1-Fc fusion protein and the application in pharmacokinetic study in rhesus monkeys</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>2011-01</date><risdate>2011</risdate><volume>54</volume><issue>1</issue><spage>133</spage><epage>140</epage><pages>133-140</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>A sensitive, accurate, and precise enzyme immunoassay (EIA) for the quantification of intact human B7.1-Fc in rhesus monkey serum was validated, and the characteristics of B7.1 and Fc moiety of fusion protein were identified by surface plasmon resonance (SPR) and flow-cytometric method, respectively. B7.1-Fc bound to CD28 and CTLA-4 with
K
d values of 45.1 and 9.58
nM, respectively, which were very closed to the previous reports and the function of Fc moiety of fusion protein was also confirmed by Fc receptor binding assay and IL-8 releasing assay. To monitor the intact protein, the EIA method employed a sandwich scheme in which a multiclonal anti-human IgG (Fc specific) antibody and a monoclonal anti-human B7.1 antibody were served as capture and detection antibody, respectively. This EIA has a range of reliable response of 0.5–32
ng/ml. The LLOQ was established at 0.5
ng/ml. The intra-assay precision and accuracy were 6.1–8.8% and (3.0–9.0)%, respectively with the inter-assay precision and accuracy were 5.7–11.5% and (10.7–9.1)%, respectively. Stability was established under certain conditions and no significant differences were found. This validated EIA assay was then successfully employed in the assessment of pharmacokinetic behavior of B7.1-Fc in rhesus monkeys after intravenous infusion, and a non-linear characteristics was established across the investigated dosage range (32–320
μg/kg).</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>20801597</pmid><doi>10.1016/j.jpba.2010.07.040</doi><tpages>8</tpages></addata></record> |
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| subjects | Analysis Analytical, structural and metabolic biochemistry Animals Antibodies, Monoclonal - chemistry Antibody Affinity antibody detection Antigens, CD - chemistry B7-1 Antigen - chemistry B7.1-Fc Biological and medical sciences blood serum CD28 Antigens - chemistry Chemistry, Pharmaceutical - methods CTLA-4 Antigen Enzyme immunoassay enzyme immunoassays Flow cytometry Fundamental and applied biological sciences. Psychology General pharmacology Humans Immunoenzyme Techniques - methods Immunoglobulin Fc Fragments - chemistry immunoglobulin G interleukin-8 Interleukin-8 - metabolism intravenous injection Kinetics Macaca mulatta Medical sciences Mice monoclonal antibodies Pharmacokinetics Pharmacology. Drug treatments Reproducibility of Results Surface plasmon resonance |
| title | Qualitative and quantitative studies on human B7.1-Fc fusion protein and the application in pharmacokinetic study in rhesus monkeys |
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