Bioprocessing最新文献

{"title":"Antibody-Dependent Cellular Phagocytosis: The Mechanism of Action That Gets No Respect A Discussion About Improving Bioassay Reproducibility","authors":"U. Herbrand","doi":"10.12665/J151.HERBRAND","DOIUrl":"https://doi.org/10.12665/J151.HERBRAND","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"15 1","pages":"26-29"},"PeriodicalIF":0.0,"publicationDate":"2016-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Contamination Triangle: A New Model for Assessing the Risk of Biological Process Contamination and Performing Investigations","authors":"Bill Ogden","doi":"10.12665/J151.OGDEN","DOIUrl":"https://doi.org/10.12665/J151.OGDEN","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"15 1","pages":"49-53"},"PeriodicalIF":0.0,"publicationDate":"2016-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum: What, When, and Where?","authors":"R. Versteegen","doi":"10.12665/J151.VERSTEEGEN","DOIUrl":"https://doi.org/10.12665/J151.VERSTEEGEN","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"15 1","pages":"18-21"},"PeriodicalIF":0.0,"publicationDate":"2016-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fetal Bovine Serum: Risk Management","authors":"W. Siegel","doi":"10.12665/J151.SIEGEL","DOIUrl":"https://doi.org/10.12665/J151.SIEGEL","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"15 1","pages":"22-25"},"PeriodicalIF":0.0,"publicationDate":"2016-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a Novel Flow Cytometry-Based Titration Assay to Quantify Herpes Simplex Virus Type 1 (HSV-1)","authors":"N. Krishna, B. Lassiter, A. Ferraioli, K. Cunnion, P. Lundberg","doi":"10.12665/J151.KRISHNA","DOIUrl":"https://doi.org/10.12665/J151.KRISHNA","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"15 1","pages":"43-48"},"PeriodicalIF":0.0,"publicationDate":"2016-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Biopharmaceutical Manufacturing Yield Using Neural Network Classification","authors":"Will Fahey, Paula Carroll","doi":"10.12665/J144.CARROLL","DOIUrl":"https://doi.org/10.12665/J144.CARROLL","url":null,"abstract":": Traditionally, the Six Sigma framework has underpinned quality improvement and assurance in biopharmaceutical manufacturing process management. This paper proposes a Neural Network (NN) approach to vaccine yield classification. The NN is compared to an existing Multiple Linear regression approach. This paper shows how a Data Mining framework can be used to extract further value and insight from the data gathered during the manufacturing process as part of the Six Sigma process. Insights to yield classification can be used in the quality improvement process.","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"14 1","pages":"39-50"},"PeriodicalIF":0.0,"publicationDate":"2016-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology","authors":"Timothy J Hahn, B. Webb, J. Kutney, Ed Fix, Nancy Nidel, James Wong, Dana Jendrek, Celia Baula, Jody Lichaa, M. Sowers, Ye V. Liu, J. Higgins, K. Roh, Zheng Meng, C. Oliver, Erica Shane, L. Ellingsworth, S. Boddapati, Christi Mcdowell-Patterson, Ziping Wei, O. Borisov, W. Cheung, Jingning Li, Victor Gavrilov, Kathleen Callahan, K. Bengtsson, Magnus Sävenhed, M. Sjölund, Susanna Macmillar, Malin Schenerfelt, Linda Stertman, C. Andersson, K. Ranlund, J. Reimer, Denise Courbron, Steve Bearman, V. Moore, D. N. Thomas, Amy Fix, L. Fries, G. Glenn, Gale Smith","doi":"10.12665/J141.HAHN","DOIUrl":"https://doi.org/10.12665/J141.HAHN","url":null,"abstract":"F or the ongoing 2014 Ebola virus outbreak, all viable options and technologies need to be evaluated as potential countermeasures to address this emerging biological threat. Novavax, Inc. has a rapid, practical vaccine development and manufacturing platform with the capability to deliver clinical trial material and, ultimately, commercial doses in response to novel infectious disease agents.[1-3] This report describes the application of our platform technology for the successful generation, manufacture, and release of a clinical batch of Zaire ebolavirus glycoprotein nanoparticle vaccine three months from project initiation. The key enabling factors were: • An integrated project plan and frequent cross-functional response team meetings • Forward processing of intermediates prior to completion of quality control testing • Rapid development and confirmation of the platform process at laboratory-scale • Advanced use of the baculovirus master virus seed to bypass production of the working virus seed • Rapid analytical method development • A manufacturing process that employs single-use manufacturing technology • Collaboration and flexibility from key raw material suppliers and contracted service providers Introduction In 1976, a new virus (later designated genus Ebolavirus), which caused acute hemorrhagic fever in people of Zaire (now the Democratic Republic of Congo) was reported.[4] Since then, five ebolavirus species have been identified. The species designated Zaire ebolavirus (EBOV), Sudan ebolavirus, and Bundibugyo ebolavirus have caused multiple, major Ebola virus disease (EVD) outbreaks in Africa.[5] From 1976 to 2013, EVD is estimated to have claimed the lives of 1590 people.[6] In March 2014, the United Nations World Health Organization (WHO) was notified of a new outbreak of EVD in Guinea that had expanded to Liberia . Further outbreaks were identified in Sierra Leone (May) and Nigeria (July).[6] In August, WHO DirectorGeneral Dr. Margaret Chan declared a public health emergency of international concern, characterizing the 2014 EVD outbreak as “the largest, By TIMOTHY J. HAHN, BRIAN WEBB, JOHN KUTNEY, ED FIX, NANCY NIDEL, JAMES WONG, DANA JENDREK, CELIA BAULA, JODY LICHAA, MIKE SOWERS, YE V. LIU, JOHN HIGGINS, KWAN-HO ROH, ZHENG MENG, CYNTHIA OLIVER, ERICA SHANE, LARRY ELLINGSWORTH, SARATHI BODDAPATI, CHRISTI MCDOWELL-PATTERSON, ZIPING WEI, OLEG BORISOV, WIN CHEUNG, JINGNING LI, VICTOR GAVRILOV, KATHLEEN CALLAHAN, KARIN LÖVGREN BENGTSSON, MAGNUS SÄVENHED, MATS SJÖLUND, SUSANNA MACMILLAR, MALIN SCHENERFELT, LINDA STERTMAN, CAMILLA ANDERSSON, KATARINA RANLUND, JENNY REIMER, DENISE COURBRON, STEPHEN J. BEARMAN, VALERIE MOORE, D. NIGEL THOMAS, AMY B. FIX, LOUIS F. FRIES, GREGORY M. GLENN, and GALE E. SMITH Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology IMAGE: Created by microbiologist Cynthia Goldsmith, Centers for Disease Control a","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"14 1","pages":"6-14"},"PeriodicalIF":0.0,"publicationDate":"2015-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statistical Verification that One Round of Fluorescence-Activated Cell Sorting (FACS) Can Effectively Generate a Clonally-Derived Cell Line","authors":"Lara E Krebs, Jin-xin Gao, C. Frye","doi":"10.12665/J134.KREBS","DOIUrl":"https://doi.org/10.12665/J134.KREBS","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"13 1","pages":"6-19"},"PeriodicalIF":0.0,"publicationDate":"2015-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biopharmaceutical Manufacturing: Historical and Future Trends in Titers, Yields, and Efficiency in Commercial-Scale Bioprocessing","authors":"E. Langer, R. Rader","doi":"10.12665/J134.LANGER","DOIUrl":"https://doi.org/10.12665/J134.LANGER","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"13 1","pages":"47-54"},"PeriodicalIF":0.0,"publicationDate":"2015-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterization of a Lyophilized Immunoaffinity Chromatography Matrix Employed to Purify Hepatitis B Surface Antigen for Pharmaceutical Use","authors":"Miguel Castillo, G. Hernández, Eduardo Sánchez, T. Álvarez, A. Musacchio, L. Milá, R. López, Daily Hernández, W. Ferro, Dobián Cecilia, A. Tamayo, J. Montero, Regla Somoza, Tatiana González, Yurisleydi Aldama, Julio Valdés, J. Marcelo, R. Valdés","doi":"10.12665/J134.VALDES","DOIUrl":"https://doi.org/10.12665/J134.VALDES","url":null,"abstract":"Immunoaffinity chromatography is an indispensable purification tool. However, its use has been limited by cost, purification cycle numbers, and storage requirements. Therefore, authors speculated that a possible solution to these problems could be CB.Hep-1 monoclonal antibody (mAb)-immunosorbent lyophilization. This study sought to assess the impact of the CB.Hep-1 mAb quantification by enzymelinked immunoadsorbent assay and the CB.Hep-1 mAbimmunosorbent lyophilization process for its impact on hepatitis B virus surface antigen purification for pharmaceutical use. Study results found that CB.Hep-1 mAb lyophilization did not affect mAb purity and antigen recognition capacity. CB.Hep-1 mAb-immunosorbent lyophilization did not modify volume-weight factor, infrared spectrum, particle-size distribution, particle density and viscosity, antigen adsorption capacity, antigen elution capacity, antigen recovery, antigen purity, gamma immunoglobulin (IgG) leakage, and purification cycle number. Therefore, the lyophilized CB.Hep-1 mAb and CB.Hep-1 mAb-immunosorbents can be successfully used for hepatitis B vaccine production.","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"13 1","pages":"35-45"},"PeriodicalIF":0.0,"publicationDate":"2015-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66229682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}