Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels
Pressures for cost‐effective new therapies and an increased emphasis on emerging markets require technological advancements and a flexible future manufacturing network for the production of biologic medicines. The safety and efficacy of a product is crucial, and consistent product quality is an esse...
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| Veröffentlicht in: | Biotechnology progress 2015-09, Vol.31 (5), p.1433-1441 |
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| container_end_page | 1441 |
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| container_issue | 5 |
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| container_title | Biotechnology progress |
| container_volume | 31 |
| creator | Zupke, Craig Brady, Lowell J. Slade, Peter G. Clark, Philip Caspary, R. Guy Livingston, Brittney Taylor, Lisa Bigham, Kyle Morris, Arvia E. Bailey, Robert W. |
| description | Pressures for cost‐effective new therapies and an increased emphasis on emerging markets require technological advancements and a flexible future manufacturing network for the production of biologic medicines. The safety and efficacy of a product is crucial, and consistent product quality is an essential feature of any therapeutic manufacturing process. The active control of product quality in a typical biologic process is challenging because of measurement lags and nonlinearities present in the system. The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. © 2015 American Institute of Chemical Engineers Biotechnol. Prog., 31:1433–1441, 2015 |
| doi_str_mv | 10.1002/btpr.2136 |
| format | Article |
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The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. © 2015 American Institute of Chemical Engineers Biotechnol. Prog., 31:1433–1441, 2015</description><identifier>ISSN: 8756-7938</identifier><identifier>EISSN: 1520-6033</identifier><identifier>DOI: 10.1002/btpr.2136</identifier><identifier>PMID: 26179435</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Animals ; Antibodies - metabolism ; CHO Cells ; control lever ; Cricetulus ; critical quality attributes (CQA) ; Emerging markets ; glycosylation ; high mannose ; Humans ; mannose ; Manufacturing industry ; Models, Chemical ; Nonlinear Dynamics ; Pilot Projects ; Polysaccharides - chemistry ; quality by design (QbD) ; Quality Control</subject><ispartof>Biotechnology progress, 2015-09, Vol.31 (5), p.1433-1441</ispartof><rights>2015 American Institute of Chemical Engineers</rights><rights>2015 American Institute of Chemical Engineers.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4616-bf4b146af20a6866f7869151a0a27e1bb86649a48c3691e404050042ab10db593</citedby><cites>FETCH-LOGICAL-c4616-bf4b146af20a6866f7869151a0a27e1bb86649a48c3691e404050042ab10db593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fbtpr.2136$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fbtpr.2136$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26179435$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zupke, Craig</creatorcontrib><creatorcontrib>Brady, Lowell J.</creatorcontrib><creatorcontrib>Slade, Peter G.</creatorcontrib><creatorcontrib>Clark, Philip</creatorcontrib><creatorcontrib>Caspary, R. 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The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. © 2015 American Institute of Chemical Engineers Biotechnol. Prog., 31:1433–1441, 2015</description><subject>Animals</subject><subject>Antibodies - metabolism</subject><subject>CHO Cells</subject><subject>control lever</subject><subject>Cricetulus</subject><subject>critical quality attributes (CQA)</subject><subject>Emerging markets</subject><subject>glycosylation</subject><subject>high mannose</subject><subject>Humans</subject><subject>mannose</subject><subject>Manufacturing industry</subject><subject>Models, Chemical</subject><subject>Nonlinear Dynamics</subject><subject>Pilot Projects</subject><subject>Polysaccharides - chemistry</subject><subject>quality by design (QbD)</subject><subject>Quality Control</subject><issn>8756-7938</issn><issn>1520-6033</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqN0ctu1DAUBmALgei0sOAFkCU2dJH2-BLbWdJCB6SqoGq47Cw7OQG3uQy2Q5m3J8MMXSAhsbJ19J1fOvoJecbghAHwU5_X8YQzoR6QBSs5FAqEeEgWRpeq0JUwB-QwpRsAMKD4Y3LAFdOVFOWCuGt0XZFDj3Qdx2aqM3U5x-CnjLQehxzHjuaR9m6YWlfnKSJ1Qw5-bAImehfyN9pgGwZs6FXRheF2_nztNrUbaIc_sEtPyKPWdQmf7t8j8vHizer8bXH5fvnu_NVlUUvFVOFb6ZlUruXglFGq1UZVrGQOHNfIvJ9nsnLS1GKeowQJJYDkzjNofFmJI_Jylzvf8X3ClG0fUo1d5wYcp2SZFtxwyaD8D8p1ZSpjzExf_EVvxikO8yFbpbQB-Vsd71Qdx5QitnYdQ-_ixjKw24rstiK7rWi2z_eJk--xuZd_OpnB6Q7chQ43_06yZ6sP1_vIYrcRUsaf9xsu3lqlhS7t56ulZavXS7m6-GS_iF9A26lV</recordid><startdate>201509</startdate><enddate>201509</enddate><creator>Zupke, Craig</creator><creator>Brady, Lowell J.</creator><creator>Slade, Peter G.</creator><creator>Clark, Philip</creator><creator>Caspary, R. 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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Animals Antibodies - metabolism CHO Cells control lever Cricetulus critical quality attributes (CQA) Emerging markets glycosylation high mannose Humans mannose Manufacturing industry Models, Chemical Nonlinear Dynamics Pilot Projects Polysaccharides - chemistry quality by design (QbD) Quality Control |
| title | Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels |
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