High Throughput Protein Formulation Platform: Case Study of Salmon Calcitonin
Purpose The feasibility of using high throughput spectroscopy for characterization and selection of physically stable protein formulations was studied. Materials and Methods A hundred aqueous formulations of salmon calcitonin (sCT) were prepared using 20 buffer compositions. The solutions had pH val...
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description | Purpose The feasibility of using high throughput spectroscopy for characterization and selection of physically stable protein formulations was studied. Materials and Methods A hundred aqueous formulations of salmon calcitonin (sCT) were prepared using 20 buffer compositions. The solutions had pH values between 2.5 and 10.5. The stability of the sCT formulations was analyzed over 1 week by the following assays: (1) protein concentration, (2) volume control by measuring pathlength, (3) turbidity (absorbance at 350 nm), (4) intrinsic tyrosine fluorescence, (5) 1-anilino-naphthalene-8-sulfonate (ANS) fluorescence, (6) Nile Red fluorescence. Addition of the dyes (Nile Red and ANS) was used to study protein conformational changes. Results After 1 day, 27 out of the 100 formulations of salmon calcitonin were stable. After 7 days, 12 stable sCT formulations remained. The best salmon calcitonin formulation was in 10 mM sodium acetate buffer with pH values between 3.5 and 5.5. Conclusions The findings are in accordance with the sCT formulations that were patented and used commercially. This can be considered as a proof of concept for the high throughput protein formulation platform. |
doi_str_mv | 10.1007/s11095-008-9662-8 |
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H ; Gurny, Robert ; Arvinte, Tudor</creator><creatorcontrib>Capelle, Martinus A. H ; Gurny, Robert ; Arvinte, Tudor</creatorcontrib><description>Purpose The feasibility of using high throughput spectroscopy for characterization and selection of physically stable protein formulations was studied. Materials and Methods A hundred aqueous formulations of salmon calcitonin (sCT) were prepared using 20 buffer compositions. The solutions had pH values between 2.5 and 10.5. The stability of the sCT formulations was analyzed over 1 week by the following assays: (1) protein concentration, (2) volume control by measuring pathlength, (3) turbidity (absorbance at 350 nm), (4) intrinsic tyrosine fluorescence, (5) 1-anilino-naphthalene-8-sulfonate (ANS) fluorescence, (6) Nile Red fluorescence. Addition of the dyes (Nile Red and ANS) was used to study protein conformational changes. Results After 1 day, 27 out of the 100 formulations of salmon calcitonin were stable. After 7 days, 12 stable sCT formulations remained. The best salmon calcitonin formulation was in 10 mM sodium acetate buffer with pH values between 3.5 and 5.5. Conclusions The findings are in accordance with the sCT formulations that were patented and used commercially. This can be considered as a proof of concept for the high throughput protein formulation platform.</description><identifier>ISSN: 0724-8741</identifier><identifier>EISSN: 1573-904X</identifier><identifier>DOI: 10.1007/s11095-008-9662-8</identifier><identifier>PMID: 18600433</identifier><identifier>CODEN: PHREEB</identifier><language>eng</language><publisher>Boston: Boston : Springer US</publisher><subject>Anilino Naphthalenesulfonates - chemistry ; Biochemistry ; Biological and medical sciences ; Biomedical and Life Sciences ; Biomedical Engineering and Bioengineering ; Biomedicine ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - chemistry ; Buffers ; Calcitonin - administration & dosage ; Calcitonin - chemistry ; Chemistry, Pharmaceutical ; Drug Evaluation, Preclinical - methods ; Feasibility studies ; Fluorescent Dyes ; General pharmacology ; high throughput screening ; Hydrogen-Ion Concentration ; Medical Law ; Medical sciences ; Oxazines ; Pharmaceutical sciences ; Pharmaceutical Solutions ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Pharmacy ; protein formulation ; Proteins ; Research Paper ; Salmon ; salmon calcitonin ; Spectrometry, Fluorescence ; Spectrophotometry, Ultraviolet ; spectroscopy ; Spectrum analysis ; stability</subject><ispartof>Pharmaceutical research, 2009-01, Vol.26 (1), p.118-128</ispartof><rights>Springer Science+Business Media, LLC 2008</rights><rights>2009 INIST-CNRS</rights><rights>Springer Science+Business Media, LLC 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c532t-4fb9aa091a7e2911f8e456ecaa0b8ffa947f41599e01e3376aec2f6a0c8faf723</citedby><cites>FETCH-LOGICAL-c532t-4fb9aa091a7e2911f8e456ecaa0b8ffa947f41599e01e3376aec2f6a0c8faf723</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11095-008-9662-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11095-008-9662-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21062718$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18600433$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Capelle, Martinus A. H</creatorcontrib><creatorcontrib>Gurny, Robert</creatorcontrib><creatorcontrib>Arvinte, Tudor</creatorcontrib><title>High Throughput Protein Formulation Platform: Case Study of Salmon Calcitonin</title><title>Pharmaceutical research</title><addtitle>Pharm Res</addtitle><addtitle>Pharm Res</addtitle><description>Purpose The feasibility of using high throughput spectroscopy for characterization and selection of physically stable protein formulations was studied. Materials and Methods A hundred aqueous formulations of salmon calcitonin (sCT) were prepared using 20 buffer compositions. The solutions had pH values between 2.5 and 10.5. The stability of the sCT formulations was analyzed over 1 week by the following assays: (1) protein concentration, (2) volume control by measuring pathlength, (3) turbidity (absorbance at 350 nm), (4) intrinsic tyrosine fluorescence, (5) 1-anilino-naphthalene-8-sulfonate (ANS) fluorescence, (6) Nile Red fluorescence. Addition of the dyes (Nile Red and ANS) was used to study protein conformational changes. Results After 1 day, 27 out of the 100 formulations of salmon calcitonin were stable. After 7 days, 12 stable sCT formulations remained. The best salmon calcitonin formulation was in 10 mM sodium acetate buffer with pH values between 3.5 and 5.5. Conclusions The findings are in accordance with the sCT formulations that were patented and used commercially. This can be considered as a proof of concept for the high throughput protein formulation platform.</description><subject>Anilino Naphthalenesulfonates - chemistry</subject><subject>Biochemistry</subject><subject>Biological and medical sciences</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedical Engineering and Bioengineering</subject><subject>Biomedicine</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - chemistry</subject><subject>Buffers</subject><subject>Calcitonin - administration & dosage</subject><subject>Calcitonin - chemistry</subject><subject>Chemistry, Pharmaceutical</subject><subject>Drug Evaluation, Preclinical - methods</subject><subject>Feasibility studies</subject><subject>Fluorescent Dyes</subject><subject>General pharmacology</subject><subject>high throughput screening</subject><subject>Hydrogen-Ion Concentration</subject><subject>Medical Law</subject><subject>Medical sciences</subject><subject>Oxazines</subject><subject>Pharmaceutical sciences</subject><subject>Pharmaceutical Solutions</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>protein formulation</subject><subject>Proteins</subject><subject>Research Paper</subject><subject>Salmon</subject><subject>salmon calcitonin</subject><subject>Spectrometry, Fluorescence</subject><subject>Spectrophotometry, Ultraviolet</subject><subject>spectroscopy</subject><subject>Spectrum analysis</subject><subject>stability</subject><issn>0724-8741</issn><issn>1573-904X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kcFuFDEMhiMEokvhAbjACAluA3aSSSbc0IpSpCIqbStxi7xpsjvVzGRJZg59e7KaFZU4cLJsf_5t_WbsNcJHBNCfMiKYpgZoa6MUr9snbIWNFrUB-espW4Hmsm61xDP2Iud7KCAa-ZydYasApBAr9uOy2-2rm32K825_mKfqOsXJd2N1EdMw9zR1cayuSwwl_1ytKftqM813D1UM1Yb6obTX1LtuimM3vmTPAvXZvzrFc3Z78fVmfVlf_fz2ff3lqnaN4FMtw9YQgUHSnhvE0HrZKO9KbduGQEbqILExxgN6IbQi73hQBK4NFDQX5-zDontI8ffs82SHLjvf9zT6OGerlJaKQ1vAd_-A93FOY7nNcs41omyaAuECuRRzTj7YQ-oGSg8WwR6NtovRtvhnj0bbo_Cbk_C8Hfzd48TJ2QK8PwGUHfUh0ei6_JfjCKrsPwrxhculNe58erzwf9vfLkOBoqVdKsK3Gw4ooLyfcwPiD_Gjnkk</recordid><startdate>20090101</startdate><enddate>20090101</enddate><creator>Capelle, Martinus A. 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H ; Gurny, Robert ; Arvinte, Tudor</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c532t-4fb9aa091a7e2911f8e456ecaa0b8ffa947f41599e01e3376aec2f6a0c8faf723</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Anilino Naphthalenesulfonates - chemistry</topic><topic>Biochemistry</topic><topic>Biological and medical sciences</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedical Engineering and Bioengineering</topic><topic>Biomedicine</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - chemistry</topic><topic>Buffers</topic><topic>Calcitonin - administration & dosage</topic><topic>Calcitonin - chemistry</topic><topic>Chemistry, Pharmaceutical</topic><topic>Drug Evaluation, Preclinical - methods</topic><topic>Feasibility studies</topic><topic>Fluorescent Dyes</topic><topic>General pharmacology</topic><topic>high throughput screening</topic><topic>Hydrogen-Ion Concentration</topic><topic>Medical Law</topic><topic>Medical sciences</topic><topic>Oxazines</topic><topic>Pharmaceutical sciences</topic><topic>Pharmaceutical Solutions</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>protein formulation</topic><topic>Proteins</topic><topic>Research Paper</topic><topic>Salmon</topic><topic>salmon calcitonin</topic><topic>Spectrometry, Fluorescence</topic><topic>Spectrophotometry, Ultraviolet</topic><topic>spectroscopy</topic><topic>Spectrum analysis</topic><topic>stability</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Capelle, Martinus A. H</creatorcontrib><creatorcontrib>Gurny, Robert</creatorcontrib><creatorcontrib>Arvinte, Tudor</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>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</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)</collection><collection>ProQuest Central</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>PML(ProQuest Medical Library)</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>Capelle, Martinus A. H</au><au>Gurny, Robert</au><au>Arvinte, Tudor</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High Throughput Protein Formulation Platform: Case Study of Salmon Calcitonin</atitle><jtitle>Pharmaceutical research</jtitle><stitle>Pharm Res</stitle><addtitle>Pharm Res</addtitle><date>2009-01-01</date><risdate>2009</risdate><volume>26</volume><issue>1</issue><spage>118</spage><epage>128</epage><pages>118-128</pages><issn>0724-8741</issn><eissn>1573-904X</eissn><coden>PHREEB</coden><abstract>Purpose The feasibility of using high throughput spectroscopy for characterization and selection of physically stable protein formulations was studied. Materials and Methods A hundred aqueous formulations of salmon calcitonin (sCT) were prepared using 20 buffer compositions. The solutions had pH values between 2.5 and 10.5. The stability of the sCT formulations was analyzed over 1 week by the following assays: (1) protein concentration, (2) volume control by measuring pathlength, (3) turbidity (absorbance at 350 nm), (4) intrinsic tyrosine fluorescence, (5) 1-anilino-naphthalene-8-sulfonate (ANS) fluorescence, (6) Nile Red fluorescence. Addition of the dyes (Nile Red and ANS) was used to study protein conformational changes. Results After 1 day, 27 out of the 100 formulations of salmon calcitonin were stable. After 7 days, 12 stable sCT formulations remained. The best salmon calcitonin formulation was in 10 mM sodium acetate buffer with pH values between 3.5 and 5.5. Conclusions The findings are in accordance with the sCT formulations that were patented and used commercially. This can be considered as a proof of concept for the high throughput protein formulation platform.</abstract><cop>Boston</cop><pub>Boston : Springer US</pub><pmid>18600433</pmid><doi>10.1007/s11095-008-9662-8</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Anilino Naphthalenesulfonates - chemistry Biochemistry Biological and medical sciences Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - chemistry Buffers Calcitonin - administration & dosage Calcitonin - chemistry Chemistry, Pharmaceutical Drug Evaluation, Preclinical - methods Feasibility studies Fluorescent Dyes General pharmacology high throughput screening Hydrogen-Ion Concentration Medical Law Medical sciences Oxazines Pharmaceutical sciences Pharmaceutical Solutions Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Pharmacology/Toxicology Pharmacy protein formulation Proteins Research Paper Salmon salmon calcitonin Spectrometry, Fluorescence Spectrophotometry, Ultraviolet spectroscopy Spectrum analysis stability |
title | High Throughput Protein Formulation Platform: Case Study of Salmon Calcitonin |
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