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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.
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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.
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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.
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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.
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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.
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Evaluation of Extractables from Product-Contact Surfacesby the Biopharmaceutical Process Extractables Core Team, including Don Miller, Bayer; Bob Seely, Amgen; John Bennan, ComplianceNet, Inc.; Frank Bing, Abbott Laboratories; Heather Boone, Genentech; Jim Fernandez, Fernandez and Associates; and Harold van Deinse, Baxter Healthcare Corporation Potential interactions between a drug product and its packaging or container closure have always been important considerations for parenteral manufacturers. Now ? at a time of increased regulatory interest in extractables, lower limits of detection, and more biopharmaceuticals reaching commercial stage ? the consequences of not evaluating the extractables in your process stream can be significant. Participants from more than 15 biopharmaceutical companies and data collected for more than 25 years were used to develop the parameters of this article.
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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.
Latest:
Evaluation of Extractables from Product-Contact Surfacesby the Biopharmaceutical Process Extractables Core Team, including Don Miller, Bayer; Bob Seely, Amgen; John Bennan, ComplianceNet, Inc.; Frank Bing, Abbott Laboratories; Heather Boone, Genentech; Jim Fernandez, Fernandez and Associates; and Harold van Deinse, Baxter Healthcare Corporation Potential interactions between a drug product and its packaging or container closure have always been important considerations for parenteral manufacturers. Now ? at a time of increased regulatory interest in extractables, lower limits of detection, and more biopharmaceuticals reaching commercial stage ? the consequences of not evaluating the extractables in your process stream can be significant. Participants from more than 15 biopharmaceutical companies and data collected for more than 25 years were used to develop the parameters of this article.
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:
Evaluation of Extractables from Product-Contact Surfacesby the Biopharmaceutical Process Extractables Core Team, including Don Miller, Bayer; Bob Seely, Amgen; John Bennan, ComplianceNet, Inc.; Frank Bing, Abbott Laboratories; Heather Boone, Genentech; Jim Fernandez, Fernandez and Associates; and Harold van Deinse, Baxter Healthcare Corporation Potential interactions between a drug product and its packaging or container closure have always been important considerations for parenteral manufacturers. Now ? at a time of increased regulatory interest in extractables, lower limits of detection, and more biopharmaceuticals reaching commercial stage ? the consequences of not evaluating the extractables in your process stream can be significant. Participants from more than 15 biopharmaceutical companies and data collected for more than 25 years were used to develop the parameters of this article.
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Analytical Advances: The Protein ID Autobahn ? Automated Nanoelectrospray Mass Spectrometryby Gary Schultz, Advion BioSciences
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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:
Evaluation of Extractables from Product-Contact Surfacesby the Biopharmaceutical Process Extractables Core Team, including Don Miller, Bayer; Bob Seely, Amgen; John Bennan, ComplianceNet, Inc.; Frank Bing, Abbott Laboratories; Heather Boone, Genentech; Jim Fernandez, Fernandez and Associates; and Harold van Deinse, Baxter Healthcare Corporation Potential interactions between a drug product and its packaging or container closure have always been important considerations for parenteral manufacturers. Now ? at a time of increased regulatory interest in extractables, lower limits of detection, and more biopharmaceuticals reaching commercial stage ? the consequences of not evaluating the extractables in your process stream can be significant. Participants from more than 15 biopharmaceutical companies and data collected for more than 25 years were used to develop the parameters of this article.
Latest:
Evaluation of Extractables from Product-Contact Surfacesby the Biopharmaceutical Process Extractables Core Team, including Don Miller, Bayer; Bob Seely, Amgen; John Bennan, ComplianceNet, Inc.; Frank Bing, Abbott Laboratories; Heather Boone, Genentech; Jim Fernandez, Fernandez and Associates; and Harold van Deinse, Baxter Healthcare Corporation Potential interactions between a drug product and its packaging or container closure have always been important considerations for parenteral manufacturers. Now ? at a time of increased regulatory interest in extractables, lower limits of detection, and more biopharmaceuticals reaching commercial stage ? the consequences of not evaluating the extractables in your process stream can be significant. Participants from more than 15 biopharmaceutical companies and data collected for more than 25 years were used to develop the parameters of this article.
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.
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:
Evaluation of Extractables from Product-Contact Surfacesby the Biopharmaceutical Process Extractables Core Team, including Don Miller, Bayer; Bob Seely, Amgen; John Bennan, ComplianceNet, Inc.; Frank Bing, Abbott Laboratories; Heather Boone, Genentech; Jim Fernandez, Fernandez and Associates; and Harold van Deinse, Baxter Healthcare Corporation Potential interactions between a drug product and its packaging or container closure have always been important considerations for parenteral manufacturers. Now ? at a time of increased regulatory interest in extractables, lower limits of detection, and more biopharmaceuticals reaching commercial stage ? the consequences of not evaluating the extractables in your process stream can be significant. Participants from more than 15 biopharmaceutical companies and data collected for more than 25 years were used to develop the parameters of this article.
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Biotech World: India Blossomsby Gordon Kelley, BioPharm International India's rapidly growing biotech sector is infused with optimism.
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Monitoring and Controlling Biocatalytic Processesby John Woodley and Paul A. Bird, the Advanced Centre for Biochemical Engineering at University College, London, and David C.A. Sharp, Pfizer Global R&D. Increased selectivity and byproduct prevention are some of the advantages of using biocatalytic processes for manufacturing chiral products and chemical intermediates. yet no industrial processes are currently using biocatalysts with Baeyer?Villiger monooxygenases because, among other factors, available monitoring and control techniques have not been rapid enough to prevent reactant and product inhibition. However, as the authors describe, rapid monitoring and control can now be achieved using near-infrared spectroscopy that, during tests, resulted in a 30% gain in productivity.
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Monitoring and Controlling Biocatalytic Processesby John Woodley and Paul A. Bird, the Advanced Centre for Biochemical Engineering at University College, London, and David C.A. Sharp, Pfizer Global R&D. Increased selectivity and byproduct prevention are some of the advantages of using biocatalytic processes for manufacturing chiral products and chemical intermediates. yet no industrial processes are currently using biocatalysts with Baeyer?Villiger monooxygenases because, among other factors, available monitoring and control techniques have not been rapid enough to prevent reactant and product inhibition. However, as the authors describe, rapid monitoring and control can now be achieved using near-infrared spectroscopy that, during tests, resulted in a 30% gain in productivity.
Latest:
Monitoring and Controlling Biocatalytic Processesby John Woodley and Paul A. Bird, the Advanced Centre for Biochemical Engineering at University College, London, and David C.A. Sharp, Pfizer Global R&D. Increased selectivity and byproduct prevention are some of the advantages of using biocatalytic processes for manufacturing chiral products and chemical intermediates. yet no industrial processes are currently using biocatalysts with Baeyer?Villiger monooxygenases because, among other factors, available monitoring and control techniques have not been rapid enough to prevent reactant and product inhibition. However, as the authors describe, rapid monitoring and control can now be achieved using near-infrared spectroscopy that, during tests, resulted in a 30% gain in productivity.
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Survival Strategies: Board Compensation Changing with the Timesby Jack Dolmat, Clark/Bardes Consulting Compensation for board members varies widely with company size, but as more is expected, compensation practices are changing too.
