Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product
Purpose ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the...
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| Veröffentlicht in: | Pharmaceutical research 2020-06, Vol.37 (6), p.114-114, Article 114 |
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| creator | Saleem, Ramsey Cantin, Greg Wikström, Mats Bolton, Glen Kuhns, Scott McBride, Helen J. Liu, Jennifer |
| description | Purpose
ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the European Union (infliximab [EU]), using sensitive, state-of-the-art analytical methods capable of detecting minor differences in product quality attributes.
Methods
Comprehensive analytical characterization utilizing orthogonal techniques was performed with 14 to 28 unique lots of ABP 710 or infliximab RP, depending on the assay. Comparisons were used to investigate the primary structure related to amino acid sequence; post-translational modifications (PTMs) including glycans; higher order structure; particles and aggregates; primary biological properties mediated by target and receptor binding; product-related substances and impurities; and general properties.
Results
ABP 710 had the same amino acid sequence, primary structure, higher order structure, PTM profiles and biological activities as infliximab RP. The finished drug product had the same strength (protein content and concentration) as infliximab RP.
Conclusions
Based on the comprehensive analytical similarity assessment, ABP 710 was found to be highly analytically similar to infliximab RP for all biological activities relevant for clinical efficacy and safety. |
| doi_str_mv | 10.1007/s11095-020-02816-w |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7261735</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A747438720</galeid><sourcerecordid>A747438720</sourcerecordid><originalsourceid>FETCH-LOGICAL-c541t-2f7d92012a919abdbdaeeeffad714d6e727e6c76ce2c334e265940dfb9ce76603</originalsourceid><addsrcrecordid>eNp9kl1rFTEQhhdR7LH6B7yQgDdeuDVfm2xuhG2xWihY_ADvQk52cpqym9Rk13r-vTnd2loRCSEw88ybmeGtqucEHxCM5ZtMCFZNjSkutyWivnpQrUgjWa0w__awWmFJed1KTvaqJzlfYIxbovjjao9RLgUWbFWdd8EM28lbMyATenQ8Bzv5WILosx_9YJKftqjLGXIeIUwoOtQdniFJ8Gtk0KGPecHQFNFJcIP_6UezRp_AQYJgAZ2l2M92elo9cmbI8Ozm3a--Hr_7cvShPv34_uSoO61tw8lUUyd7RTGhRhFl1v26NwDgnOkl4b0ASSUIK4UFahnjQEWjOO7dWlmQQmC2X71ddC_n9Qi9LT0nM-jLVNpKWx2N1_czwZ_rTfyhJRVEsqYIvLoRSPH7DHnSo88WhsEEiHPWlOO2Ya3CtKAv_0Iv4pzK7q4pqRrFWnJHbcwA2gcXy792J6o7ySVnraS7vg_-QZXTw-htDOB8id8roEuBTTHnBO52RoL1zh968Ycu_tDX_tBXpejFn9u5LfltiAKwBcglFTaQ7kb6j-wvo7DGEg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2407959381</pqid></control><display><type>article</type><title>Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product</title><source>MEDLINE</source><source>SpringerLink (Online service)</source><creator>Saleem, Ramsey ; Cantin, Greg ; Wikström, Mats ; Bolton, Glen ; Kuhns, Scott ; McBride, Helen J. ; Liu, Jennifer</creator><creatorcontrib>Saleem, Ramsey ; Cantin, Greg ; Wikström, Mats ; Bolton, Glen ; Kuhns, Scott ; McBride, Helen J. ; Liu, Jennifer</creatorcontrib><description>Purpose
ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the European Union (infliximab [EU]), using sensitive, state-of-the-art analytical methods capable of detecting minor differences in product quality attributes.
Methods
Comprehensive analytical characterization utilizing orthogonal techniques was performed with 14 to 28 unique lots of ABP 710 or infliximab RP, depending on the assay. Comparisons were used to investigate the primary structure related to amino acid sequence; post-translational modifications (PTMs) including glycans; higher order structure; particles and aggregates; primary biological properties mediated by target and receptor binding; product-related substances and impurities; and general properties.
Results
ABP 710 had the same amino acid sequence, primary structure, higher order structure, PTM profiles and biological activities as infliximab RP. The finished drug product had the same strength (protein content and concentration) as infliximab RP.
Conclusions
Based on the comprehensive analytical similarity assessment, ABP 710 was found to be highly analytically similar to infliximab RP for all biological activities relevant for clinical efficacy and safety.</description><identifier>ISSN: 0724-8741</identifier><identifier>EISSN: 1573-904X</identifier><identifier>DOI: 10.1007/s11095-020-02816-w</identifier><identifier>PMID: 32476063</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Amino Acid Sequence ; Amino acids ; Antibodies, Monoclonal - analysis ; Biochemistry ; Biological products ; Biomedical and Life Sciences ; Biomedical Engineering and Bioengineering ; Biomedicine ; Biosimilar Pharmaceuticals - analysis ; Biosimilar Pharmaceuticals - chemistry ; Circular Dichroism ; Humans ; Immunotherapy ; Impurities ; Infliximab ; Infliximab - analysis ; Infliximab - chemistry ; Medical Law ; Monoclonal antibodies ; Nutrient content ; Pharmacology/Toxicology ; Pharmacy ; Polysaccharides ; Post-translation ; Protein Processing, Post-Translational ; Quality management ; Research Paper ; Spectroscopy, Fourier Transform Infrared ; Structure-function relationships ; TNF inhibitors ; Tumor necrosis factor-α</subject><ispartof>Pharmaceutical research, 2020-06, Vol.37 (6), p.114-114, Article 114</ispartof><rights>The Author(s) 2020</rights><rights>COPYRIGHT 2020 Springer</rights><rights>The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c541t-2f7d92012a919abdbdaeeeffad714d6e727e6c76ce2c334e265940dfb9ce76603</citedby><cites>FETCH-LOGICAL-c541t-2f7d92012a919abdbdaeeeffad714d6e727e6c76ce2c334e265940dfb9ce76603</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/s11095-020-02816-w$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11095-020-02816-w$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32476063$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Saleem, Ramsey</creatorcontrib><creatorcontrib>Cantin, Greg</creatorcontrib><creatorcontrib>Wikström, Mats</creatorcontrib><creatorcontrib>Bolton, Glen</creatorcontrib><creatorcontrib>Kuhns, Scott</creatorcontrib><creatorcontrib>McBride, Helen J.</creatorcontrib><creatorcontrib>Liu, Jennifer</creatorcontrib><title>Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product</title><title>Pharmaceutical research</title><addtitle>Pharm Res</addtitle><addtitle>Pharm Res</addtitle><description>Purpose
ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the European Union (infliximab [EU]), using sensitive, state-of-the-art analytical methods capable of detecting minor differences in product quality attributes.
Methods
Comprehensive analytical characterization utilizing orthogonal techniques was performed with 14 to 28 unique lots of ABP 710 or infliximab RP, depending on the assay. Comparisons were used to investigate the primary structure related to amino acid sequence; post-translational modifications (PTMs) including glycans; higher order structure; particles and aggregates; primary biological properties mediated by target and receptor binding; product-related substances and impurities; and general properties.
Results
ABP 710 had the same amino acid sequence, primary structure, higher order structure, PTM profiles and biological activities as infliximab RP. The finished drug product had the same strength (protein content and concentration) as infliximab RP.
Conclusions
Based on the comprehensive analytical similarity assessment, ABP 710 was found to be highly analytically similar to infliximab RP for all biological activities relevant for clinical efficacy and safety.</description><subject>Amino Acid Sequence</subject><subject>Amino acids</subject><subject>Antibodies, Monoclonal - analysis</subject><subject>Biochemistry</subject><subject>Biological products</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedical Engineering and Bioengineering</subject><subject>Biomedicine</subject><subject>Biosimilar Pharmaceuticals - analysis</subject><subject>Biosimilar Pharmaceuticals - chemistry</subject><subject>Circular Dichroism</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Impurities</subject><subject>Infliximab</subject><subject>Infliximab - analysis</subject><subject>Infliximab - chemistry</subject><subject>Medical Law</subject><subject>Monoclonal antibodies</subject><subject>Nutrient content</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Polysaccharides</subject><subject>Post-translation</subject><subject>Protein Processing, Post-Translational</subject><subject>Quality management</subject><subject>Research Paper</subject><subject>Spectroscopy, Fourier Transform Infrared</subject><subject>Structure-function relationships</subject><subject>TNF inhibitors</subject><subject>Tumor necrosis factor-α</subject><issn>0724-8741</issn><issn>1573-904X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kl1rFTEQhhdR7LH6B7yQgDdeuDVfm2xuhG2xWihY_ADvQk52cpqym9Rk13r-vTnd2loRCSEw88ybmeGtqucEHxCM5ZtMCFZNjSkutyWivnpQrUgjWa0w__awWmFJed1KTvaqJzlfYIxbovjjao9RLgUWbFWdd8EM28lbMyATenQ8Bzv5WILosx_9YJKftqjLGXIeIUwoOtQdniFJ8Gtk0KGPecHQFNFJcIP_6UezRp_AQYJgAZ2l2M92elo9cmbI8Ozm3a--Hr_7cvShPv34_uSoO61tw8lUUyd7RTGhRhFl1v26NwDgnOkl4b0ASSUIK4UFahnjQEWjOO7dWlmQQmC2X71ddC_n9Qi9LT0nM-jLVNpKWx2N1_czwZ_rTfyhJRVEsqYIvLoRSPH7DHnSo88WhsEEiHPWlOO2Ya3CtKAv_0Iv4pzK7q4pqRrFWnJHbcwA2gcXy792J6o7ySVnraS7vg_-QZXTw-htDOB8id8roEuBTTHnBO52RoL1zh968Ycu_tDX_tBXpejFn9u5LfltiAKwBcglFTaQ7kb6j-wvo7DGEg</recordid><startdate>20200601</startdate><enddate>20200601</enddate><creator>Saleem, Ramsey</creator><creator>Cantin, Greg</creator><creator>Wikström, Mats</creator><creator>Bolton, Glen</creator><creator>Kuhns, Scott</creator><creator>McBride, Helen J.</creator><creator>Liu, Jennifer</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>C6C</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>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><scope>5PM</scope></search><sort><creationdate>20200601</creationdate><title>Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product</title><author>Saleem, Ramsey ; Cantin, Greg ; Wikström, Mats ; Bolton, Glen ; Kuhns, Scott ; McBride, Helen J. ; Liu, Jennifer</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c541t-2f7d92012a919abdbdaeeeffad714d6e727e6c76ce2c334e265940dfb9ce76603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Amino Acid Sequence</topic><topic>Amino acids</topic><topic>Antibodies, Monoclonal - analysis</topic><topic>Biochemistry</topic><topic>Biological products</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedical Engineering and Bioengineering</topic><topic>Biomedicine</topic><topic>Biosimilar Pharmaceuticals - analysis</topic><topic>Biosimilar Pharmaceuticals - chemistry</topic><topic>Circular Dichroism</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Impurities</topic><topic>Infliximab</topic><topic>Infliximab - analysis</topic><topic>Infliximab - chemistry</topic><topic>Medical Law</topic><topic>Monoclonal antibodies</topic><topic>Nutrient content</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Polysaccharides</topic><topic>Post-translation</topic><topic>Protein Processing, Post-Translational</topic><topic>Quality management</topic><topic>Research Paper</topic><topic>Spectroscopy, Fourier Transform Infrared</topic><topic>Structure-function relationships</topic><topic>TNF inhibitors</topic><topic>Tumor necrosis factor-α</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Saleem, Ramsey</creatorcontrib><creatorcontrib>Cantin, Greg</creatorcontrib><creatorcontrib>Wikström, Mats</creatorcontrib><creatorcontrib>Bolton, Glen</creatorcontrib><creatorcontrib>Kuhns, Scott</creatorcontrib><creatorcontrib>McBride, Helen J.</creatorcontrib><creatorcontrib>Liu, Jennifer</creatorcontrib><collection>Springer_OA刊</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>ProQuest_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>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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pharmaceutical research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Saleem, Ramsey</au><au>Cantin, Greg</au><au>Wikström, Mats</au><au>Bolton, Glen</au><au>Kuhns, Scott</au><au>McBride, Helen J.</au><au>Liu, Jennifer</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product</atitle><jtitle>Pharmaceutical research</jtitle><stitle>Pharm Res</stitle><addtitle>Pharm Res</addtitle><date>2020-06-01</date><risdate>2020</risdate><volume>37</volume><issue>6</issue><spage>114</spage><epage>114</epage><pages>114-114</pages><artnum>114</artnum><issn>0724-8741</issn><eissn>1573-904X</eissn><abstract>Purpose
ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the European Union (infliximab [EU]), using sensitive, state-of-the-art analytical methods capable of detecting minor differences in product quality attributes.
Methods
Comprehensive analytical characterization utilizing orthogonal techniques was performed with 14 to 28 unique lots of ABP 710 or infliximab RP, depending on the assay. Comparisons were used to investigate the primary structure related to amino acid sequence; post-translational modifications (PTMs) including glycans; higher order structure; particles and aggregates; primary biological properties mediated by target and receptor binding; product-related substances and impurities; and general properties.
Results
ABP 710 had the same amino acid sequence, primary structure, higher order structure, PTM profiles and biological activities as infliximab RP. The finished drug product had the same strength (protein content and concentration) as infliximab RP.
Conclusions
Based on the comprehensive analytical similarity assessment, ABP 710 was found to be highly analytically similar to infliximab RP for all biological activities relevant for clinical efficacy and safety.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>32476063</pmid><doi>10.1007/s11095-020-02816-w</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Pharmaceutical research, 2020-06, Vol.37 (6), p.114-114, Article 114 |
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| subjects | Amino Acid Sequence Amino acids Antibodies, Monoclonal - analysis Biochemistry Biological products Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Biosimilar Pharmaceuticals - analysis Biosimilar Pharmaceuticals - chemistry Circular Dichroism Humans Immunotherapy Impurities Infliximab Infliximab - analysis Infliximab - chemistry Medical Law Monoclonal antibodies Nutrient content Pharmacology/Toxicology Pharmacy Polysaccharides Post-translation Protein Processing, Post-Translational Quality management Research Paper Spectroscopy, Fourier Transform Infrared Structure-function relationships TNF inhibitors Tumor necrosis factor-α |
| title | Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product |
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