Authors
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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.
Latest:
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.
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Biotech World: Contract Manufacturing: Diversity in the European Marketplaceby David Venables, Q-One Biotech Ltd. Approximately 75 vendors offer biological contract manufacturing services in Europe ? a manageable data set for analyzing the services they provide.
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Survival Strategies: Keeping Tabs on Trainingby Vicki Cloutier, Guidant Corporation It's not enough to train your staff ? you have to keep training them. A good learning management system can help.
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HPLE Sugars Improve Stability and Drug ProductHigh-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.
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Comparing the Supply Lifecycle of BioreactorsUnderstanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.
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Survival Strategies: How to Purchase COTS Softwareby David Nettleton, Computer System Validation Because perspectives of software vendors and users are different, there is no guarantee that commercial, off-the-shelf software will meet the user's requirements.
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Guest Editorial: Recruiting Biotech Talentby Stacey A. Denenberg, Vic E. Myer, and David M. Chao, Akceli, Inc.
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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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Guest Editorial: Recruiting Biotech Talentby Stacey A. Denenberg, Vic E. Myer, and David M. Chao, Akceli, Inc.
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Guest Editorial: Recruiting Biotech Talentby Stacey A. Denenberg, Vic E. Myer, and David M. Chao, Akceli, Inc.
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Optimized Nutrient Additives for Fed-Batch Culturesby Stephen F. Gorfien, GIBCO Cell Culture R&D, Invitrogen Corporation William Paul, David Judd, Lia Tescione, and David W. Jayme Cell density, longevity, and expression are the economics of cell cultures in biopharmaceutical production ? and rich growth media are the investment. Glucose and glutamine are primary energy sources for culture growth, but their associated metabolic wastes can actually harm cell cultures. Adapting cell lines to reduced levels of glucose and glutamine, then feeding the culture chemically defined nutrient supplements, increases cell viability, maximizes cell density, and increases product expression.
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Using Peptide Maps as Identity and Purity Tests for Lot Release Testing of Recombinant Therapeutic Proteinsby John Dougherty, Eli Lilly and Company, Rohin Mhatre, Biogen, Inc., and Stephen Moore, CDER FDA and biopharmaceutical industry stakeholders reach consensus on critical issues related to the use of peptide maps as identity tests for proteins and on their usefulness for lot release tests. The results of that discussion are presented here.
Latest:
Using Peptide Maps as Identity and Purity Tests for Lot Release Testing of Recombinant Therapeutic Proteinsby John Dougherty, Eli Lilly and Company, Rohin Mhatre, Biogen, Inc., and Stephen Moore, CDER FDA and biopharmaceutical industry stakeholders reach consensus on critical issues related to the use of peptide maps as identity tests for proteins and on their usefulness for lot release tests. The results of that discussion are presented here.
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Commercial Production of Transgenic Crops Genetically Engineered to Produce Pharmaceuticalsby Lon Crosby Farmers may be the pharmaceutical producers of the 21st Century. The technology exists, and practices commonly used in agriculture can be modified to meet envisioned GMPs ? and those modifications are within reach.
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Optimized Nutrient Additives for Fed-Batch Culturesby Stephen F. Gorfien, GIBCO Cell Culture R&D, Invitrogen Corporation William Paul, David Judd, Lia Tescione, and David W. Jayme Cell density, longevity, and expression are the economics of cell cultures in biopharmaceutical production ? and rich growth media are the investment. Glucose and glutamine are primary energy sources for culture growth, but their associated metabolic wastes can actually harm cell cultures. Adapting cell lines to reduced levels of glucose and glutamine, then feeding the culture chemically defined nutrient supplements, increases cell viability, maximizes cell density, and increases product expression.
Latest:
Optimized Nutrient Additives for Fed-Batch Culturesby Stephen F. Gorfien, GIBCO Cell Culture R&D, Invitrogen Corporation William Paul, David Judd, Lia Tescione, and David W. Jayme Cell density, longevity, and expression are the economics of cell cultures in biopharmaceutical production ? and rich growth media are the investment. Glucose and glutamine are primary energy sources for culture growth, but their associated metabolic wastes can actually harm cell cultures. Adapting cell lines to reduced levels of glucose and glutamine, then feeding the culture chemically defined nutrient supplements, increases cell viability, maximizes cell density, and increases product expression.
Latest:
Using Peptide Maps as Identity and Purity Tests for Lot Release Testing of Recombinant Therapeutic Proteinsby John Dougherty, Eli Lilly and Company, Rohin Mhatre, Biogen, Inc., and Stephen Moore, CDER FDA and biopharmaceutical industry stakeholders reach consensus on critical issues related to the use of peptide maps as identity tests for proteins and on their usefulness for lot release tests. The results of that discussion are presented here.
Latest:
Patent Law: Extracting Maximum Value from Your Patent Portfolioby Craig R. Kaufman, Orrick, Herrington & Sutcliffe LLP, Rebecca Burton, and Anne-Marie Dinius Your patent portfolio does not make money sitting in a file cabinet. Extracting its value requires both market surveillance and an effective litigation or licensing strategy.
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A Statistical Method to Account for Plate-to-Plate Variability in Multiple-Plate Bioassaysby James D. Williams, Virginia Polytechnic Institute and State University, Jeffrey B. Birch, and Steven Walfish Statistics don't lie, but if you don't include appropriate data, the resulting statistical analyses can be misleading. In biopharmaceutical development, if the variability from several different microplates is not addressed, assays testing the relative potency against a standard can be inaccurate. A statistical method that accounts for plate-to-plate heterogeneity is needed ? and presented here.
Latest:
Patent Law: Extracting Maximum Value from Your Patent Portfolioby Craig R. Kaufman, Orrick, Herrington & Sutcliffe LLP, Rebecca Burton, and Anne-Marie Dinius Your patent portfolio does not make money sitting in a file cabinet. Extracting its value requires both market surveillance and an effective litigation or licensing strategy.
Latest:
Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliersby Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
Latest:
Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliersby Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
Latest:
Patent Law: Extracting Maximum Value from Your Patent Portfolioby Craig R. Kaufman, Orrick, Herrington & Sutcliffe LLP, Rebecca Burton, and Anne-Marie Dinius Your patent portfolio does not make money sitting in a file cabinet. Extracting its value requires both market surveillance and an effective litigation or licensing strategy.
Latest:
Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliersby Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
Latest:
A Statistical Method to Account for Plate-to-Plate Variability in Multiple-Plate Bioassaysby James D. Williams, Virginia Polytechnic Institute and State University, Jeffrey B. Birch, and Steven Walfish Statistics don't lie, but if you don't include appropriate data, the resulting statistical analyses can be misleading. In biopharmaceutical development, if the variability from several different microplates is not addressed, assays testing the relative potency against a standard can be inaccurate. A statistical method that accounts for plate-to-plate heterogeneity is needed ? and presented here.
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SOX in the Boardroom: What the Sarbanes?Oxley Act Means to Youby Penny Cass, BioPharm International Stay current on the changes in corporate governance regulations ? whether your company is public or private, in the United States or elsewhere. As a capital-intensive industry, many of our third-party associations are going to require that biopharmaceutical companies comply with the new regulations to receive financing. The trend to regulate corporate governance activities hasn't ended ? more rules promulgated by more government entities should be anticipated.
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Analytical Advances: Collaborative Effort Results in Automated Cell Culture Systemby Sean Sales, RTS Life Science International RTS Life Science International works with clients to develop modular system.
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The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industryby Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."
