The Impact of the Metal Interface on the Stability and Quality of a Therapeutic Fusion Protein
Subvisible particle formation, which occurs after the sterile filtration step of the fill/finish process, is a challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless steel pump head from a rotary piston pump produces more...
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| Veröffentlicht in: | Molecular pharmaceutics 2020-02, Vol.17 (2), p.569-578, Article acs.molpharmaceut.9b01000 |
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| creator | Defante, Adrian P Kalonia, Cavan K Keegan, Emma Bishop, Steven M Satish, Hasige A Hudson, Steven D Santacroce, Paul V |
| description | Subvisible particle formation, which occurs after the sterile filtration step of the fill/finish process, is a challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless steel pump head from a rotary piston pump produces more protein aggregates, past the limit of the acceptable quality range for subvisible particle counts, in comparison to a ceramic pump head. The quartz crystal microbalance was used to quantify the primary layer, proteins irreversibly adsorbed at the solid–liquid interface, and the secondary diffuse gel-like layer interacting on top of the primary layer. The results showed that the mass of protein irreversibly adsorbed onto stainless steel sensors is greater than on an aluminum oxide surface (ceramic pump mimic). This suggests that the amount of adsorbed protein plays a role in surface-induced protein aggregation at the solid–liquid interface. |
| doi_str_mv | 10.1021/acs.molpharmaceut.9b01000 |
| format | Article |
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Pharmaceutics</addtitle><description>Subvisible particle formation, which occurs after the sterile filtration step of the fill/finish process, is a challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless steel pump head from a rotary piston pump produces more protein aggregates, past the limit of the acceptable quality range for subvisible particle counts, in comparison to a ceramic pump head. The quartz crystal microbalance was used to quantify the primary layer, proteins irreversibly adsorbed at the solid–liquid interface, and the secondary diffuse gel-like layer interacting on top of the primary layer. The results showed that the mass of protein irreversibly adsorbed onto stainless steel sensors is greater than on an aluminum oxide surface (ceramic pump mimic). This suggests that the amount of adsorbed protein plays a role in surface-induced protein aggregation at the solid–liquid interface.</description><subject>Adsorption</subject><subject>Aluminum Oxide - chemistry</subject><subject>Antibodies, Monoclonal, Humanized - chemistry</subject><subject>Antibodies, Monoclonal, Humanized - genetics</subject><subject>Ceramics - chemistry</subject><subject>Drug Compounding - methods</subject><subject>Drug Stability</subject><subject>Immunoglobulin Fc Fragments - chemistry</subject><subject>Immunoglobulin Fc Fragments - genetics</subject><subject>Immunoglobulin G - chemistry</subject><subject>Immunoglobulin G - genetics</subject><subject>Life Sciences & Biomedicine</subject><subject>Medicine, Research & Experimental</subject><subject>Pharmacology & Pharmacy</subject><subject>Protein Aggregates</subject><subject>Quartz Crystal Microbalance Techniques</subject><subject>Research & Experimental Medicine</subject><subject>Science & Technology</subject><subject>Stainless Steel - chemistry</subject><subject>Surface Properties</subject><subject>Tumor Necrosis Factor-alpha - chemistry</subject><subject>Tumor Necrosis Factor-alpha - genetics</subject><issn>1543-8384</issn><issn>1543-8392</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>AOWDO</sourceid><sourceid>EIF</sourceid><recordid>eNqNkU9v1DAQxSMEoqXwFVC4IaFd_C_EOSG0orBSESDKFWvijFlXiR1sB9Rvz7S7rOitJ4_t996M_auqF5ytORP8Ndi8nuI47yBNYHEp665nnDH2oDrljZIrLTvx8FhrdVI9yfmKMaEaIR9XJ5J3vG20PK1-XO6w3k4z2FJHVxfafcICY70NBZOj9DqG2-NvBXo_-nJdQxjqrwvc1uSBmjISzDSHt_X5kj05vqRY0Ien1SMHY8Znh_Ws-n7-_nLzcXXx-cN28-5iBYp3ZTUIpjutVYtKWhiYgF5oJ1XrNBukdYoz1Ar7XjnJkEvR8EYyzV2PrbYS5Fn1dp87L_2Eg8VQEoxmTn6CdG0ieHP3Jvid-Rl_G04f2jDeUsLLQ0KKvxbMxUw-WxxHCBiXbISUb0Qju1aQtNtLbYo5J3THPpyZG0CGAJk7gMwBEHmf_z_o0fmPCAle7QV_sI8uW4_B4lFGEQ3nhFFSxTWp9f3VG1-gEJxNXEIha7O33gx7FZcUCNA9XvAXh-XGEA</recordid><startdate>20200203</startdate><enddate>20200203</enddate><creator>Defante, Adrian P</creator><creator>Kalonia, Cavan K</creator><creator>Keegan, Emma</creator><creator>Bishop, Steven M</creator><creator>Satish, Hasige A</creator><creator>Hudson, Steven D</creator><creator>Santacroce, Paul V</creator><general>American Chemical Society</general><general>Amer Chemical Soc</general><scope>AOWDO</scope><scope>BLEPL</scope><scope>DTL</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><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6590-1123</orcidid><orcidid>https://orcid.org/0000-0002-3203-4833</orcidid></search><sort><creationdate>20200203</creationdate><title>The Impact of the Metal Interface on the Stability and Quality of a Therapeutic Fusion Protein</title><author>Defante, Adrian P ; Kalonia, Cavan K ; Keegan, Emma ; Bishop, Steven M ; Satish, Hasige A ; Hudson, Steven D ; Santacroce, Paul V</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a419t-d20898847e43cad02ab28f347f80d3cf410e84ebb4f30e1325153081fbe78c3a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adsorption</topic><topic>Aluminum Oxide - chemistry</topic><topic>Antibodies, Monoclonal, Humanized - chemistry</topic><topic>Antibodies, Monoclonal, Humanized - genetics</topic><topic>Ceramics - chemistry</topic><topic>Drug Compounding - methods</topic><topic>Drug Stability</topic><topic>Immunoglobulin Fc Fragments - chemistry</topic><topic>Immunoglobulin Fc Fragments - genetics</topic><topic>Immunoglobulin G - chemistry</topic><topic>Immunoglobulin G - genetics</topic><topic>Life Sciences & Biomedicine</topic><topic>Medicine, Research & Experimental</topic><topic>Pharmacology & Pharmacy</topic><topic>Protein Aggregates</topic><topic>Quartz Crystal Microbalance Techniques</topic><topic>Research & Experimental Medicine</topic><topic>Science & Technology</topic><topic>Stainless Steel - chemistry</topic><topic>Surface Properties</topic><topic>Tumor Necrosis Factor-alpha - chemistry</topic><topic>Tumor Necrosis Factor-alpha - genetics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Defante, Adrian P</creatorcontrib><creatorcontrib>Kalonia, Cavan K</creatorcontrib><creatorcontrib>Keegan, Emma</creatorcontrib><creatorcontrib>Bishop, Steven M</creatorcontrib><creatorcontrib>Satish, Hasige A</creatorcontrib><creatorcontrib>Hudson, Steven D</creatorcontrib><creatorcontrib>Santacroce, Paul V</creatorcontrib><collection>Web of Science - Science Citation Index Expanded - 2020</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Molecular pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Defante, Adrian P</au><au>Kalonia, Cavan K</au><au>Keegan, Emma</au><au>Bishop, Steven M</au><au>Satish, Hasige A</au><au>Hudson, Steven D</au><au>Santacroce, Paul V</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Impact of the Metal Interface on the Stability and Quality of a Therapeutic Fusion Protein</atitle><jtitle>Molecular pharmaceutics</jtitle><stitle>MOL PHARMACEUT</stitle><addtitle>Mol. Pharmaceutics</addtitle><date>2020-02-03</date><risdate>2020</risdate><volume>17</volume><issue>2</issue><spage>569</spage><epage>578</epage><pages>569-578</pages><artnum>acs.molpharmaceut.9b01000</artnum><issn>1543-8384</issn><eissn>1543-8392</eissn><abstract>Subvisible particle formation, which occurs after the sterile filtration step of the fill/finish process, is a challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless steel pump head from a rotary piston pump produces more protein aggregates, past the limit of the acceptable quality range for subvisible particle counts, in comparison to a ceramic pump head. The quartz crystal microbalance was used to quantify the primary layer, proteins irreversibly adsorbed at the solid–liquid interface, and the secondary diffuse gel-like layer interacting on top of the primary layer. The results showed that the mass of protein irreversibly adsorbed onto stainless steel sensors is greater than on an aluminum oxide surface (ceramic pump mimic). This suggests that the amount of adsorbed protein plays a role in surface-induced protein aggregation at the solid–liquid interface.</abstract><cop>WASHINGTON</cop><pub>American Chemical Society</pub><pmid>31917583</pmid><doi>10.1021/acs.molpharmaceut.9b01000</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-6590-1123</orcidid><orcidid>https://orcid.org/0000-0002-3203-4833</orcidid></addata></record> |
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| subjects | Adsorption Aluminum Oxide - chemistry Antibodies, Monoclonal, Humanized - chemistry Antibodies, Monoclonal, Humanized - genetics Ceramics - chemistry Drug Compounding - methods Drug Stability Immunoglobulin Fc Fragments - chemistry Immunoglobulin Fc Fragments - genetics Immunoglobulin G - chemistry Immunoglobulin G - genetics Life Sciences & Biomedicine Medicine, Research & Experimental Pharmacology & Pharmacy Protein Aggregates Quartz Crystal Microbalance Techniques Research & Experimental Medicine Science & Technology Stainless Steel - chemistry Surface Properties Tumor Necrosis Factor-alpha - chemistry Tumor Necrosis Factor-alpha - genetics |
| title | The Impact of the Metal Interface on the Stability and Quality of a Therapeutic Fusion Protein |
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