Authors
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:
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.
Latest:
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.
Latest:
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.
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.
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.
Latest:
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.
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Guidelines for Optimization and Scale-Up in Preparative ChromatographyAnurag Rathore, Pharmacia Corporation and Ajoy Velayudhan Optimizing your purification and separation process when your complex biological feedstock is ready for scale-up can be daunting. Your design process can be streamlined, simplified, and made cost efficient if you supplement your empirical approach with the theoretical and experimental tools presented in this article.
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Outsourcing Outlook: Using Virtual Private Networks to Gain Competitive Advantageby Mark Tuomenoska, OpenReach, Inc. and Jim Miller, Bio/Pharmaceutical Outsourcing Report Outsourcing can be a booster rocket in the race to patent and market innovative products.
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Reducing Costs by Facility Designby Leaford Blevins and Tom Gerbo, HDR Facility design can affect the bottom line in biopharmaceutical manufacturing. The authors offer insights about what to look for and what to consider in facility design ? whether you're retrofitting an existing facility or building from the ground up.
Latest:
Reducing Costs by Facility Designby Leaford Blevins and Tom Gerbo, HDR Facility design can affect the bottom line in biopharmaceutical manufacturing. The authors offer insights about what to look for and what to consider in facility design ? whether you're retrofitting an existing facility or building from the ground up.
Latest:
Rethinking the Economics of Chromatography: New Technologies and Hidden Costsby Tim N. Warner and Sam Nuchumson, Pall Life Sciences If the hidden expenses associated with laboratory purchases ? labor, cleaning, buffers, validation, time delays ? are identified, reduced processing costs, higher throughput, and accelerated time-to-market are possible. This comparison between resin and membrane chromatography helps shed light on some hidden costs.
Latest:
Rethinking the Economics of Chromatography: New Technologies and Hidden Costsby Tim N. Warner and Sam Nuchumson, Pall Life Sciences If the hidden expenses associated with laboratory purchases ? labor, cleaning, buffers, validation, time delays ? are identified, reduced processing costs, higher throughput, and accelerated time-to-market are possible. This comparison between resin and membrane chromatography helps shed light on some hidden costs.
Latest:
Analytical Advances: Funneling a Flood Tide of Data ? New Software Accelerates Bioinformatic Analysesby David Butler, Spotfire Inc.
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Becoming a Partner of Choice and Evaluating Prospective Alliancesby David Wallis, Dechert and Jan Heybroek Whether you're on the inlicensing or outlicensing side of a collaboration, attention must be paid to putting forth the right image and learning about your prospective partners before the alliance is struck.
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Becoming a Partner of Choice and Evaluating Prospective Alliancesby David Wallis, Dechert and Jan Heybroek Whether you're on the inlicensing or outlicensing side of a collaboration, attention must be paid to putting forth the right image and learning about your prospective partners before the alliance is struck.
Latest:
Getting Ready for Risk-Based GMPsby Patrick Clinton, BioPharm International As FDA moves toward a new vision of GMP regulations, BioPharm International asked industry experts some key quextions: What form will risk-based GMPs take? What are the benefits and costs for biotech? Will the change really encourage innovation? And, most important, can FDA leaders get field inspectors to buy into the new approach?
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Using Amino Acid Analysis to Determine Absorptivity Constants: A Validation Case Study Using Bovine Serum Albuminby John C. Anders, aaiPharma, Inc., Benne F. Parten, Glenn E. Petrie , Robert L. Marlowe , and John E. McEntire Amino acid analysis (AAA) of well-recovered residues offers an easy way to calculate the absorptivity constant for a known protein. The method provides an absolute measure of protein concentration, free from interference from water, excipients, and bound salts. This article demonstrates a qualified method for determining protein content by AAA.
