Authors
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Optimizing Recombinant Microbial Fermentation Processes: An Integrated Approachby Karl Bayer, Monika Cserjan-Puschmann, Reingard Grabherr, Gerald Striedner, and Franz Clementschitsch, Institute of Applied Microbiology, Vienna, Austria A new strategy for controlling recombinant gene expression improves efficiency, maximizes host vector exploitation, reduces costs, improves product consistency, and accelerates product development. Continuous feeds of limited amounts of inducer proportional to biomass growth grant optimal control over the ratio between gene expression and host cell metabolism, providing stable, prolonged recombinant protein production.
Latest:
Optimizing Recombinant Microbial Fermentation Processes: An Integrated Approachby Karl Bayer, Monika Cserjan-Puschmann, Reingard Grabherr, Gerald Striedner, and Franz Clementschitsch, Institute of Applied Microbiology, Vienna, Austria A new strategy for controlling recombinant gene expression improves efficiency, maximizes host vector exploitation, reduces costs, improves product consistency, and accelerates product development. Continuous feeds of limited amounts of inducer proportional to biomass growth grant optimal control over the ratio between gene expression and host cell metabolism, providing stable, prolonged recombinant protein production.
Latest:
Optimizing Recombinant Microbial Fermentation Processes: An Integrated Approachby Karl Bayer, Monika Cserjan-Puschmann, Reingard Grabherr, Gerald Striedner, and Franz Clementschitsch, Institute of Applied Microbiology, Vienna, Austria A new strategy for controlling recombinant gene expression improves efficiency, maximizes host vector exploitation, reduces costs, improves product consistency, and accelerates product development. Continuous feeds of limited amounts of inducer proportional to biomass growth grant optimal control over the ratio between gene expression and host cell metabolism, providing stable, prolonged recombinant protein production.
Latest:
Optimizing Recombinant Microbial Fermentation Processes: An Integrated Approachby Karl Bayer, Monika Cserjan-Puschmann, Reingard Grabherr, Gerald Striedner, and Franz Clementschitsch, Institute of Applied Microbiology, Vienna, Austria A new strategy for controlling recombinant gene expression improves efficiency, maximizes host vector exploitation, reduces costs, improves product consistency, and accelerates product development. Continuous feeds of limited amounts of inducer proportional to biomass growth grant optimal control over the ratio between gene expression and host cell metabolism, providing stable, prolonged recombinant protein production.
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Facilitating Client Audits: The Contract Laboratory Perspectiveby Gary Vinson, and Barbara Carter-Hamm, Magellan Pharmaceutical Development Pharmaceutical companies rely on outsourcing organizations that anticipate and prepare for client audits. Such contractor companies become collaborative partners. A technically proficient contract organization understands client needs, knows the regulatory environment in which drug development takes place, and sees a client audit as a professional opportunity to show its expertise.
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Outsourcing Outlook: Optimizing Cross-Organizational Team Performance and Managementby Jim Miller, PharmSource Information Services, David S. Zuckerman, Customized Improvement Strategies, and Michael B. Higgins, Belgard Consulting A sponsor?contractor team can prevent relationship failures by using a good team strategy to overcome organizational, cultural, and functional boundaries.
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Outsourcing Outlook: Optimizing Cross-Organizational Team Performance and Managementby Jim Miller, PharmSource Information Services, David S. Zuckerman, Customized Improvement Strategies, and Michael B. Higgins, Belgard Consulting A sponsor?contractor team can prevent relationship failures by using a good team strategy to overcome organizational, cultural, and functional boundaries.
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Analytical Advances: When an Industry Requires Multiterabyte Data Protectionby Ron Levine, Coast Writing
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Retrovirus and Parvovirus Clearance from an Affinity Column Product Using Adsorptive Depth Filtrationby Barbara Tipton, Jeri Ann Boose, Joanne Beck, Thomas O'Brien, and William Larsen, CUNO Incorporated Two types of depth filters are studied for their ability to rid protein solutions of retroviruses and parvoviruses. Such filters are relatively economical and easy to use, so as secondary virus-removing devices, they are beneficial for downstream processing of mammalian cell cultures. Results indicate that depth filters are more effective on retroviruses than parvoviruses.
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Part 6: Inactivation Methods Grouped by Virusby Gail Sofer, BioReliance, Dorothy C. Lister, and Jeri Ann Boose
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Outsourcing Outlook: How to Engage in a Strategic Outsourcing Relationshipby Les Blumberg, The Warren Company, and Jim MIller, Bio/Pharmaceutical Outsourcing Report Strategic Outsourcing requires discipline so companies can realize the competitive benefits in the marketplace
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Retrovirus and Parvovirus Clearance from an Affinity Column Product Using Adsorptive Depth Filtrationby Barbara Tipton, Jeri Ann Boose, Joanne Beck, Thomas O'Brien, and William Larsen, CUNO Incorporated Two types of depth filters are studied for their ability to rid protein solutions of retroviruses and parvoviruses. Such filters are relatively economical and easy to use, so as secondary virus-removing devices, they are beneficial for downstream processing of mammalian cell cultures. Results indicate that depth filters are more effective on retroviruses than parvoviruses.
Latest:
Retrovirus and Parvovirus Clearance from an Affinity Column Product Using Adsorptive Depth Filtrationby Barbara Tipton, Jeri Ann Boose, Joanne Beck, Thomas O'Brien, and William Larsen, CUNO Incorporated Two types of depth filters are studied for their ability to rid protein solutions of retroviruses and parvoviruses. Such filters are relatively economical and easy to use, so as secondary virus-removing devices, they are beneficial for downstream processing of mammalian cell cultures. Results indicate that depth filters are more effective on retroviruses than parvoviruses.
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Analytical Advances: Mapping Proteins – the 2-D Electrophoresis Issueby Kevin McAloon, Morgan Advanced Ceramics
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Throughput Analysis and Debottlenecking of Biomanufacturing Facilities ? A Job for Process Simulatorsby Demetri Petrides, Alexandros Koulouris, and Charles Siletti, Intelligen, Inc. Bottlenecks are everywhere, from the freeway overpass during the morning commute to the long lines at the supermarket. But bottlenecks in a manufacturing process are bad for business. Computer models can help you eliminate those conditions or situations that retard your progress. Whether the goal is strategic planning, evaluating alternatives, purchasing equipment, appraising a facility, or optimizing production processes, simulation tools can improve your analysis.
Latest:
Retrovirus and Parvovirus Clearance from an Affinity Column Product Using Adsorptive Depth Filtrationby Barbara Tipton, Jeri Ann Boose, Joanne Beck, Thomas O'Brien, and William Larsen, CUNO Incorporated Two types of depth filters are studied for their ability to rid protein solutions of retroviruses and parvoviruses. Such filters are relatively economical and easy to use, so as secondary virus-removing devices, they are beneficial for downstream processing of mammalian cell cultures. Results indicate that depth filters are more effective on retroviruses than parvoviruses.
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GMPs and Pharmaceutical Labelingby Dan Luedke, Keller Crescent Company FDA labeling regulations protect consumers and ensure product identity.
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Process Validation: How Much to Do and When to Do Itby Anurag S. Rathore, Joseph F. Noferi, and Edward R. Arling from Pharmacia Corporation, and Gail Sofer, Bioreliance; Peter Watler, Amgen, Inc.; and Rhona O'Leary, Genentech, Inc. The trick to process validation, these industry experts argue, is to understand that it is a process that stretches through the whole product life cycle. Some secrets of success: Take a team approach; focus on the timing of the various stages of validation; avoid some common mistakes; and build your documentation as you go.
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Bioinformatics Databases ? Questions of Copyrightby Elizabeth Howard and Gabriel Ramsey, Orrick, Herrington & Sutcliff With some planning, you can use intellectual property laws to adequately protect the wealth of data stored in your databases. Those valuable data may not be copyrightable, but the software used to store them is.
Latest:
Bioinformatics Databases ? Questions of Copyrightby Elizabeth Howard and Gabriel Ramsey, Orrick, Herrington & Sutcliff With some planning, you can use intellectual property laws to adequately protect the wealth of data stored in your databases. Those valuable data may not be copyrightable, but the software used to store them is.
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Employing Near-Infrared Spectroscopic Methods of Analysis for Fermentation Monitoring and Control: Part 2, Implementation Strategiesby S. Alison Arnold, Linda M. Harvey, and Brian McNeil, Strathclyde Fermentation Centre (Scotland), and Jeffrey W. Hall, FOSS NIRSystems Timely process information is required to make effective fermentation decisions, but those data are rarely available. NIR spectroscopy can allow you ? by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth directly into fermentation control strategies ? to make those decisions. This article will help you make that improvement by outlining the analysis strategies.
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You Have Failed . . . A Case Study in Warning Letter Remediationby Joseph Noferi, Edward R. Arling, Ralph L. Dillon, and Mikael Blomqvist, Pharmacia An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 ? that did not find contamination, but only the potential for contamination ? to 18 months later when the facility received a clean bill of health. What it did to get there ? and what it learned ? may keep your site from losing its operating freedom.
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Employing Near-Infrared Spectroscopic Methods of Analysis for Fermentation Monitoring and Control: Part 2, Implementation Strategiesby S. Alison Arnold, Linda M. Harvey, and Brian McNeil, Strathclyde Fermentation Centre (Scotland), and Jeffrey W. Hall, FOSS NIRSystems Timely process information is required to make effective fermentation decisions, but those data are rarely available. NIR spectroscopy can allow you ? by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth directly into fermentation control strategies ? to make those decisions. This article will help you make that improvement by outlining the analysis strategies.
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Outsourcing Outlook: Will CROs find opportunity in a Reinvigorated European R&D Sector?by Jim Miller and Janet Lowenbach, PharmSource Information Services The EU must harness market forces that reward innovation and competitiveness to combat its current R&D drain.
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Employing Near-Infrared Spectroscopic Methods of Analysis for Fermentation Monitoring and Control: Part 2, Implementation Strategiesby S. Alison Arnold, Linda M. Harvey, and Brian McNeil, Strathclyde Fermentation Centre (Scotland), and Jeffrey W. Hall, FOSS NIRSystems Timely process information is required to make effective fermentation decisions, but those data are rarely available. NIR spectroscopy can allow you ? by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth directly into fermentation control strategies ? to make those decisions. This article will help you make that improvement by outlining the analysis strategies.
Latest:
Employing Near-Infrared Spectroscopic Methods of Analysis for Fermentation Monitoring and Control: Part 2, Implementation Strategiesby S. Alison Arnold, Linda M. Harvey, and Brian McNeil, Strathclyde Fermentation Centre (Scotland), and Jeffrey W. Hall, FOSS NIRSystems Timely process information is required to make effective fermentation decisions, but those data are rarely available. NIR spectroscopy can allow you ? by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth directly into fermentation control strategies ? to make those decisions. This article will help you make that improvement by outlining the analysis strategies.
Latest:
Inactivating Adventitious Viruses While Preserving Biological Activity: Treating Fetal Bovine Serum with Pulsed Ultraviolet Lightby Mary Sawyer, Masoud Hosseini, Carrie Schore, and Bennie I. Osburn from School of Veterinary Medicine, University of California, Davis, department of veterinary pathology, microbiology and immunology; Joseph Vu, Baxter biosciences division; Krystyna Trzepla-Nabaglo, Celilia Pina, and Manuel Lagunas-Solar from the laser unit, Crocker Nuclear Laboratory, University of California, Davis; and Wayne Smith, department of population health and reproduction at the University of California, Davis New evidence suggests the West Nile virus can be transmitted during blood transfusion from an asymptomatic donor. However, it is now possible to use pulsed ultraviolet laser light to inactivate viruses such as West Nile at large production scales. These experimental data show that using laser light on virus-treated media can render biological products free of contaminating viruses without compromising the biological activity essential to cell cultures.
Latest:
Inactivating Adventitious Viruses While Preserving Biological Activity: Treating Fetal Bovine Serum with Pulsed Ultraviolet Lightby Mary Sawyer, Masoud Hosseini, Carrie Schore, and Bennie I. Osburn from School of Veterinary Medicine, University of California, Davis, department of veterinary pathology, microbiology and immunology; Joseph Vu, Baxter biosciences division; Krystyna Trzepla-Nabaglo, Celilia Pina, and Manuel Lagunas-Solar from the laser unit, Crocker Nuclear Laboratory, University of California, Davis; and Wayne Smith, department of population health and reproduction at the University of California, Davis New evidence suggests the West Nile virus can be transmitted during blood transfusion from an asymptomatic donor. However, it is now possible to use pulsed ultraviolet laser light to inactivate viruses such as West Nile at large production scales. These experimental data show that using laser light on virus-treated media can render biological products free of contaminating viruses without compromising the biological activity essential to cell cultures.
