In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart
Background Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarit...
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| Veröffentlicht in: | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2023-09, Vol.37 (5), p.709-719 |
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| container_title | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy |
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| creator | Mishra, Akshay G. Deshmane, Rutuja B. Thappa, Damodar K. Lona, Jeseena Ghade, Nikhil S. Sonar, Sanjay M. Krishnan, Archana R. |
| description | Background
Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays.
Objective
The objective of this study was to show the comparative in vitro characterization of the recombinant insulin aspart from BioGenomics with its originator insulin aspart, using relevant biological assays.
Methods
In vitro assays such as receptor binding, receptor autophosphorylation, glucose uptake, and mitogenic potential were analyzed for biological characterization of BioGenomics recombinant insulin aspart (BGL-ASP) manufactured by BioGenomics Limited and NovoRapid
®
as the reference medicinal product (RMP) manufactured by Novo Nordisk. Insulin receptor binding was studied by a state-of-the-art method, surface plasmon resonance (SPR) for biomolecular interactions. The receptor autophosphorylation assay measures the phosphorylated insulin receptor in cell lysates. The glucose uptake assay measures the uptake of glucose by 3T3-L1 cells in the presence of insulin. Lipogenesis was studied in treated 3T3-L1 cells by detecting the accumulation of lipid droplets in the cells. Mitogenic effect was studied by cell proliferation assay using MCF-7 cells. A rabbit bioidentity test was performed by measuring the sudden decrease in blood glucose in the presence of insulin.
Results
The binding studies showed that the affinity of BGL-ASP was highly comparable to NovoRapid
®
. Insulin receptor autophosphorylation, glucose uptake, and lipogenesis demonstrated high similarity to the RMP. The mitogenic assay for BGL-ASP did not show any proliferative effect and was comparable to the RMP. The in vivo bioidentity test showed that the BGL-ASP is highly similar to the innovator, NovoRapid
®
.
Conclusion
The biological characterization studies of BGL-ASP demonstrated high binding and functional similarity to NovoRapid
®
. |
| doi_str_mv | 10.1007/s40259-023-00607-4 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2823498448</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2853065838</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-5bae115c28d5f4f8261fb703d36adf1eb0d9a13723d988b60482145b3a9fe5ec3</originalsourceid><addsrcrecordid>eNp9kc1q3DAUhUVpaH6aF-iiCLrpxs3Vny0v0yFNBgKBkITuhCxLUwVbmkj2In36ajKTBmaRlS7oO-dKfAh9IfCDADRnmQMVbQWUVQA1NBX_gI4IadqKtPD748vMKimBH6LjnB-hUKxtPqFD1lApgNAj9LQM-MFPKeKfPg5x5Y0e8OKPTtpMNvm_evIx4OjwrTVx7HzQYcLLkOfBB3ye1zpN2KU4buIrG-LoTcY69Pgm-VWhp5j28M_owOkh29PdeYLuf13cLa6q65vL5eL8ujKsEVMlOm0JEYbKXjjuJK2J6xpgPat174jtoG81KR9hfStlVwOXlHDRMd06K6xhJ-j7tned4tNs86RGn40dBh1snLOikjLeSs5lQb_toY9xTqG8rlCCQS0k21B0S5kUc07WqXXyo07PioDaCFFbIaoIUS9CFC-hr7vquRtt_z_yaqAAbAvkchVWNr3tfqf2H6u3luM</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2853065838</pqid></control><display><type>article</type><title>In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart</title><source>SpringerNature Journals</source><creator>Mishra, Akshay G. ; Deshmane, Rutuja B. ; Thappa, Damodar K. ; Lona, Jeseena ; Ghade, Nikhil S. ; Sonar, Sanjay M. ; Krishnan, Archana R.</creator><creatorcontrib>Mishra, Akshay G. ; Deshmane, Rutuja B. ; Thappa, Damodar K. ; Lona, Jeseena ; Ghade, Nikhil S. ; Sonar, Sanjay M. ; Krishnan, Archana R.</creatorcontrib><description>Background
Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays.
Objective
The objective of this study was to show the comparative in vitro characterization of the recombinant insulin aspart from BioGenomics with its originator insulin aspart, using relevant biological assays.
Methods
In vitro assays such as receptor binding, receptor autophosphorylation, glucose uptake, and mitogenic potential were analyzed for biological characterization of BioGenomics recombinant insulin aspart (BGL-ASP) manufactured by BioGenomics Limited and NovoRapid
®
as the reference medicinal product (RMP) manufactured by Novo Nordisk. Insulin receptor binding was studied by a state-of-the-art method, surface plasmon resonance (SPR) for biomolecular interactions. The receptor autophosphorylation assay measures the phosphorylated insulin receptor in cell lysates. The glucose uptake assay measures the uptake of glucose by 3T3-L1 cells in the presence of insulin. Lipogenesis was studied in treated 3T3-L1 cells by detecting the accumulation of lipid droplets in the cells. Mitogenic effect was studied by cell proliferation assay using MCF-7 cells. A rabbit bioidentity test was performed by measuring the sudden decrease in blood glucose in the presence of insulin.
Results
The binding studies showed that the affinity of BGL-ASP was highly comparable to NovoRapid
®
. Insulin receptor autophosphorylation, glucose uptake, and lipogenesis demonstrated high similarity to the RMP. The mitogenic assay for BGL-ASP did not show any proliferative effect and was comparable to the RMP. The in vivo bioidentity test showed that the BGL-ASP is highly similar to the innovator, NovoRapid
®
.
Conclusion
The biological characterization studies of BGL-ASP demonstrated high binding and functional similarity to NovoRapid
®
.</description><identifier>ISSN: 1173-8804</identifier><identifier>EISSN: 1179-190X</identifier><identifier>DOI: 10.1007/s40259-023-00607-4</identifier><identifier>PMID: 37285012</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Antibodies ; Bioassays ; Biological activity ; Biological products ; Biomedical and Life Sciences ; Biomedicine ; Cancer Research ; Cell proliferation ; FDA approval ; Glucose ; Insulin ; Insulin receptors ; Ligands ; Lipogenesis ; Lysates ; Metabolism ; Molecular Medicine ; Original Research Article ; Pharmacotherapy ; Phosphorylation ; Proteins ; Regulatory approval ; Surface plasmon resonance ; Toxicity</subject><ispartof>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2023-09, Vol.37 (5), p.709-719</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.</rights><rights>Copyright Springer Nature B.V. Sep 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-5bae115c28d5f4f8261fb703d36adf1eb0d9a13723d988b60482145b3a9fe5ec3</citedby><cites>FETCH-LOGICAL-c375t-5bae115c28d5f4f8261fb703d36adf1eb0d9a13723d988b60482145b3a9fe5ec3</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/s40259-023-00607-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40259-023-00607-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37285012$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mishra, Akshay G.</creatorcontrib><creatorcontrib>Deshmane, Rutuja B.</creatorcontrib><creatorcontrib>Thappa, Damodar K.</creatorcontrib><creatorcontrib>Lona, Jeseena</creatorcontrib><creatorcontrib>Ghade, Nikhil S.</creatorcontrib><creatorcontrib>Sonar, Sanjay M.</creatorcontrib><creatorcontrib>Krishnan, Archana R.</creatorcontrib><title>In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart</title><title>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</title><addtitle>BioDrugs</addtitle><addtitle>BioDrugs</addtitle><description>Background
Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays.
Objective
The objective of this study was to show the comparative in vitro characterization of the recombinant insulin aspart from BioGenomics with its originator insulin aspart, using relevant biological assays.
Methods
In vitro assays such as receptor binding, receptor autophosphorylation, glucose uptake, and mitogenic potential were analyzed for biological characterization of BioGenomics recombinant insulin aspart (BGL-ASP) manufactured by BioGenomics Limited and NovoRapid
®
as the reference medicinal product (RMP) manufactured by Novo Nordisk. Insulin receptor binding was studied by a state-of-the-art method, surface plasmon resonance (SPR) for biomolecular interactions. The receptor autophosphorylation assay measures the phosphorylated insulin receptor in cell lysates. The glucose uptake assay measures the uptake of glucose by 3T3-L1 cells in the presence of insulin. Lipogenesis was studied in treated 3T3-L1 cells by detecting the accumulation of lipid droplets in the cells. Mitogenic effect was studied by cell proliferation assay using MCF-7 cells. A rabbit bioidentity test was performed by measuring the sudden decrease in blood glucose in the presence of insulin.
Results
The binding studies showed that the affinity of BGL-ASP was highly comparable to NovoRapid
®
. Insulin receptor autophosphorylation, glucose uptake, and lipogenesis demonstrated high similarity to the RMP. The mitogenic assay for BGL-ASP did not show any proliferative effect and was comparable to the RMP. The in vivo bioidentity test showed that the BGL-ASP is highly similar to the innovator, NovoRapid
®
.
Conclusion
The biological characterization studies of BGL-ASP demonstrated high binding and functional similarity to NovoRapid
®
.</description><subject>Antibodies</subject><subject>Bioassays</subject><subject>Biological activity</subject><subject>Biological products</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer Research</subject><subject>Cell proliferation</subject><subject>FDA approval</subject><subject>Glucose</subject><subject>Insulin</subject><subject>Insulin receptors</subject><subject>Ligands</subject><subject>Lipogenesis</subject><subject>Lysates</subject><subject>Metabolism</subject><subject>Molecular Medicine</subject><subject>Original Research Article</subject><subject>Pharmacotherapy</subject><subject>Phosphorylation</subject><subject>Proteins</subject><subject>Regulatory approval</subject><subject>Surface plasmon resonance</subject><subject>Toxicity</subject><issn>1173-8804</issn><issn>1179-190X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kc1q3DAUhUVpaH6aF-iiCLrpxs3Vny0v0yFNBgKBkITuhCxLUwVbmkj2In36ajKTBmaRlS7oO-dKfAh9IfCDADRnmQMVbQWUVQA1NBX_gI4IadqKtPD748vMKimBH6LjnB-hUKxtPqFD1lApgNAj9LQM-MFPKeKfPg5x5Y0e8OKPTtpMNvm_evIx4OjwrTVx7HzQYcLLkOfBB3ye1zpN2KU4buIrG-LoTcY69Pgm-VWhp5j28M_owOkh29PdeYLuf13cLa6q65vL5eL8ujKsEVMlOm0JEYbKXjjuJK2J6xpgPat174jtoG81KR9hfStlVwOXlHDRMd06K6xhJ-j7tned4tNs86RGn40dBh1snLOikjLeSs5lQb_toY9xTqG8rlCCQS0k21B0S5kUc07WqXXyo07PioDaCFFbIaoIUS9CFC-hr7vquRtt_z_yaqAAbAvkchVWNr3tfqf2H6u3luM</recordid><startdate>20230901</startdate><enddate>20230901</enddate><creator>Mishra, Akshay G.</creator><creator>Deshmane, Rutuja B.</creator><creator>Thappa, Damodar K.</creator><creator>Lona, Jeseena</creator><creator>Ghade, Nikhil S.</creator><creator>Sonar, Sanjay M.</creator><creator>Krishnan, Archana R.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20230901</creationdate><title>In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart</title><author>Mishra, Akshay G. ; Deshmane, Rutuja B. ; Thappa, Damodar K. ; Lona, Jeseena ; Ghade, Nikhil S. ; Sonar, Sanjay M. ; Krishnan, Archana R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-5bae115c28d5f4f8261fb703d36adf1eb0d9a13723d988b60482145b3a9fe5ec3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antibodies</topic><topic>Bioassays</topic><topic>Biological activity</topic><topic>Biological products</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer Research</topic><topic>Cell proliferation</topic><topic>FDA approval</topic><topic>Glucose</topic><topic>Insulin</topic><topic>Insulin receptors</topic><topic>Ligands</topic><topic>Lipogenesis</topic><topic>Lysates</topic><topic>Metabolism</topic><topic>Molecular Medicine</topic><topic>Original Research Article</topic><topic>Pharmacotherapy</topic><topic>Phosphorylation</topic><topic>Proteins</topic><topic>Regulatory approval</topic><topic>Surface plasmon resonance</topic><topic>Toxicity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mishra, Akshay G.</creatorcontrib><creatorcontrib>Deshmane, Rutuja B.</creatorcontrib><creatorcontrib>Thappa, Damodar K.</creatorcontrib><creatorcontrib>Lona, Jeseena</creatorcontrib><creatorcontrib>Ghade, Nikhil S.</creatorcontrib><creatorcontrib>Sonar, Sanjay M.</creatorcontrib><creatorcontrib>Krishnan, Archana R.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Immunology 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>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science 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 Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mishra, Akshay G.</au><au>Deshmane, Rutuja B.</au><au>Thappa, Damodar K.</au><au>Lona, Jeseena</au><au>Ghade, Nikhil S.</au><au>Sonar, Sanjay M.</au><au>Krishnan, Archana R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart</atitle><jtitle>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</jtitle><stitle>BioDrugs</stitle><addtitle>BioDrugs</addtitle><date>2023-09-01</date><risdate>2023</risdate><volume>37</volume><issue>5</issue><spage>709</spage><epage>719</epage><pages>709-719</pages><issn>1173-8804</issn><eissn>1179-190X</eissn><abstract>Background
Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays.
Objective
The objective of this study was to show the comparative in vitro characterization of the recombinant insulin aspart from BioGenomics with its originator insulin aspart, using relevant biological assays.
Methods
In vitro assays such as receptor binding, receptor autophosphorylation, glucose uptake, and mitogenic potential were analyzed for biological characterization of BioGenomics recombinant insulin aspart (BGL-ASP) manufactured by BioGenomics Limited and NovoRapid
®
as the reference medicinal product (RMP) manufactured by Novo Nordisk. Insulin receptor binding was studied by a state-of-the-art method, surface plasmon resonance (SPR) for biomolecular interactions. The receptor autophosphorylation assay measures the phosphorylated insulin receptor in cell lysates. The glucose uptake assay measures the uptake of glucose by 3T3-L1 cells in the presence of insulin. Lipogenesis was studied in treated 3T3-L1 cells by detecting the accumulation of lipid droplets in the cells. Mitogenic effect was studied by cell proliferation assay using MCF-7 cells. A rabbit bioidentity test was performed by measuring the sudden decrease in blood glucose in the presence of insulin.
Results
The binding studies showed that the affinity of BGL-ASP was highly comparable to NovoRapid
®
. Insulin receptor autophosphorylation, glucose uptake, and lipogenesis demonstrated high similarity to the RMP. The mitogenic assay for BGL-ASP did not show any proliferative effect and was comparable to the RMP. The in vivo bioidentity test showed that the BGL-ASP is highly similar to the innovator, NovoRapid
®
.
Conclusion
The biological characterization studies of BGL-ASP demonstrated high binding and functional similarity to NovoRapid
®
.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>37285012</pmid><doi>10.1007/s40259-023-00607-4</doi><tpages>11</tpages></addata></record> |
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| ispartof | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2023-09, Vol.37 (5), p.709-719 |
| issn | 1173-8804 1179-190X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2823498448 |
| source | SpringerNature Journals |
| subjects | Antibodies Bioassays Biological activity Biological products Biomedical and Life Sciences Biomedicine Cancer Research Cell proliferation FDA approval Glucose Insulin Insulin receptors Ligands Lipogenesis Lysates Metabolism Molecular Medicine Original Research Article Pharmacotherapy Phosphorylation Proteins Regulatory approval Surface plasmon resonance Toxicity |
| title | In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart |
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