{"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}
N. Krishna, B. Lassiter, A. Ferraioli, K. Cunnion, P. Lundberg
{"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}
: 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.
{"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}
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
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
对于正在进行的2014年埃博拉病毒爆发，需要评估所有可行的选择和技术，作为应对这一新出现的生物威胁的潜在对策。Novavax公司拥有一个快速、实用的疫苗开发和制造平台，有能力提供临床试验材料，并最终提供针对新型传染病病原体的商业剂量。[1-3]本报告描述了在项目启动三个月后，我们的平台技术在扎伊尔埃博拉病毒糖蛋白纳米颗粒疫苗的成功生产、生产和临床批次发布中的应用。关键的促成因素是:•综合项目计划和频繁的跨职能响应团队会议•在完成质量控制测试之前对中间体进行前处理•在实验室规模上快速开发和确认平台流程•先进使用杆状病毒主病毒种子以绕过工作病毒种子的生产•快速分析方法开发•采用一次性制造技术的制造流程•关键的协作和灵活性1976年，一种新的病毒(后来被指定为埃博拉病毒属)在扎伊尔(现刚果民主共和国)人民中引起急性出血热从那时起，已经确定了五种埃博拉病毒。扎伊尔埃博拉病毒(EBOV)、苏丹埃博拉病毒和本迪布焦埃博拉病毒已在非洲造成多次重大埃博拉病毒病(EVD)暴发从1976年到2013年，埃博拉病毒病估计夺去了1590人的生命2014年3月，联合国世界卫生组织(世卫组织)接到通知，几内亚爆发了新的埃博拉病毒病疫情，并已扩大到利比里亚。在塞拉利昂(5月)和尼日利亚(7月)发现了进一步的疫情今年8月，世卫组织总干事陈冯富珍博士宣布了一次国际关注的突发公共卫生事件，并将2014年埃博拉病毒病疫情描述为“最大的一次”。作者: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、郑bb1、CYNTHIA OLIVER、ERICA SHANE、LARRY ELLINGSWORTH、SARATHI BODDAPATI、CHRISTI MCDOWELL-PATTERSON、魏子平、OLEG BORISOV、WIN bb0、李静宁、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和GALE E. SMITH利用重组杆状病毒- sf9昆虫细胞培养技术快速生产和释放GMP批量扎伊尔埃博拉病毒糖蛋白疫苗由疾病控制和预防中心(CDC)的微生物学家辛西娅·戈德史密斯(Cynthia Goldsmith)制作，这张彩色透射电子显微照片(TEM)揭示了埃博拉病毒病毒粒子的一些超微结构形态。(http://phil.cdc.gov/phil/details.asp?pid=10816)文章发布于2015年2月10日
{"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}
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
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.
{"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}
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