Authors
Latest:
Your Vested Interests: The War of the Westby Benjamin H. Rudolph and Viqar Aslam, Aptagen, Inc. One company shows the world that stem cell research isn't coing away -- and receives a worldwide ctroversy in the process.
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High-Throughput Biopharmaceutical Drug Development: Meeting the Coming ChallengeBy Rajiv Nayar and Mark C. Manning, HTD Biosystms, Inc., pp. 20-28. Outsourcing is often considered a way to expedite drug development, but other options exist for companies that don't choose it yy} or that run up against the capacity shortage. The resources devoted to speeding up the drug discovery process led to combinatorial libraries, high-throughput screening, proteomics, and genomics. Now the same types of innovation can be applied to drug development to prevent valuable lead compounds from sitting idle on the shelf.
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The Immunogenicity of Therapeutic ProteinsBy Fiona Adair and Daniel Ozanne,Biovation Ltd., pp. 30-36. Immunogenicity is often a barrier to further development of potentially therapeutic proteins. That barrier often remains unknown until late in the development chain. The authors explore various strategies for preventing immunogenicity and for predicting it earlier in the process.
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High-Throughput Biopharmaceutical Drug Development: Meeting the Coming ChallengeBy Rajiv Nayar and Mark C. Manning, HTD Biosystms, Inc., pp. 20-28. Outsourcing is often considered a way to expedite drug development, but other options exist for companies that don't choose it yy} or that run up against the capacity shortage. The resources devoted to speeding up the drug discovery process led to combinatorial libraries, high-throughput screening, proteomics, and genomics. Now the same types of innovation can be applied to drug development to prevent valuable lead compounds from sitting idle on the shelf.
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Your Vested Interests: Gorillas In Our Midstby Benjamin H. Rudolph, Aptagen, Inc. Having a big name on your team isn't enough, but it sure helps!
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The Immunogenicity of Therapeutic ProteinsBy Fiona Adair and Daniel Ozanne,Biovation Ltd., pp. 30-36. Immunogenicity is often a barrier to further development of potentially therapeutic proteins. That barrier often remains unknown until late in the development chain. The authors explore various strategies for preventing immunogenicity and for predicting it earlier in the process.
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Sale of Your Product Can Prevent Patenting: How to Avoid the On-Sale BarBy Tom Brody, DNAX Research Institute, pp. 38-42. Early sale or offers to sell an invention may result in the rejection of a patent application under 35 U.S.C. 102(b). Such a rejection is called "the on-sale bar," and it permanently prevents patenting of an invention.
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A System Developer's Approach to Validationby Christopher L. Gent Pharmacia Corporation Validation is required for computer systems used to create, modify, maintain, archive, retrieve, or transmit data intended for submission. To ensure that the QA/QC and the IT departments speak the same language, a system developer will build documented evidence that a system's functionality has been tested, performs as specified, and generates reproducible results.
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Validation of Quantitative PCR Assays?Addressing Virus Contamination Concernsby Archie Lovatt, Donna McMutrie, John Black, and Iain Doherty Q-One Biotech Ltd. Real-time quantitative PCR has revolutionized the detection and quantification of viral contaminants. Quantitative PCR assays can detect noncytopathic viruses that have recently become a concern in testing for biopharmaceutical safety. High versatility reproducibility, and throughput of such assays decrease the time spent in development, testing, and regulatory compliance.
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The Importance of Freezing on Lyophilization Cycle Developmentby Thomas W. Patapoff and David E. Overcashier Genentech, Inc. The freezing method used during lyophilization can substantially affect the structure of the ice formed, the water-vapor flow during primary drying, and the quality of the final product. Controlling how a solution freezes can shorten lyophilization cycles and produce more stable formations.
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Business Benefits of Computer Systems Validationby Mary Jo Veverka Accenture Significant amounts of time and effort are spent on validating computer systems. Companies that want efficient, high-quality systems can avoid considerable consts by incorporating CSV capabilities throughout systems development.
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Validation of Quantitative PCR Assays?Addressing Virus Contamination Concernsby Archie Lovatt, Donna McMutrie, John Black, and Iain Doherty Q-One Biotech Ltd. Real-time quantitative PCR has revolutionized the detection and quantification of viral contaminants. Quantitative PCR assays can detect noncytopathic viruses that have recently become a concern in testing for biopharmaceutical safety. High versatility reproducibility, and throughput of such assays decrease the time spent in development, testing, and regulatory compliance.
Latest:
Validation of Quantitative PCR Assays?Addressing Virus Contamination Concernsby Archie Lovatt, Donna McMutrie, John Black, and Iain Doherty Q-One Biotech Ltd. Real-time quantitative PCR has revolutionized the detection and quantification of viral contaminants. Quantitative PCR assays can detect noncytopathic viruses that have recently become a concern in testing for biopharmaceutical safety. High versatility reproducibility, and throughput of such assays decrease the time spent in development, testing, and regulatory compliance.
Latest:
The Importance of Freezing on Lyophilization Cycle Developmentby Thomas W. Patapoff and David E. Overcashier Genentech, Inc. The freezing method used during lyophilization can substantially affect the structure of the ice formed, the water-vapor flow during primary drying, and the quality of the final product. Controlling how a solution freezes can shorten lyophilization cycles and produce more stable formations.
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Outsourcing Outlook: Using Earned-Value Analysis for Better Project Managementby Heather B Hayes, a freelance writer, and Jim Miller, publisher of the Bio/Pharmaceutical Outsourcing Report EVA allows project managers to refer to tangible numbers, not just a gut feeling, in determining whether a project is advancing on time and within budget.
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Specifications and Manufacturing Change Control: A Prototypic System for Electronic Document Tracking and Managementby Robert Zeid TLI Development The corporate fantasy where everyone knows all the systems all too often collides with a nightmare reality where all the systems are known by only a few. Any specification or manufacturing change that affects various departments can quickly become a bewildering morass of proposed, actual, and implemented changes ? with few connections to actual lots and practices. Draw a line in the CMC "sand" where those changes actually began.
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Storing an Ion-Exchange Chromatography Gel in Dilute Alkali During Recycling Improves Cleaningby Jane Turton, Central Public Health Laboratory and Zain Moola This case study shows that storing an ion-exchange chromatography gel in dilute alkalai, followed by removal of the solubized material, enhances gel cleaning. More material is removed from the gel during column recycling, and carry over of material from one cycle to the next is substantially reduced.
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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.
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Analytical Advances: Paperless or Less Paper?by Mary Ellen Goffredo, NuGenesis Technologies Corporation Weighing the Options
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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.
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Guest Editorial: The Protein Production Challengeby Roland Andersson and Richard Mynahan, Strategic Decisions Group Protect your revenues and profits from manufacturing scarcity.
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Analytical Advances: High-Throughput Purification System for Oligonucleotides Improves Synthetic Gene Productionby Doreen Pippin, Varian Inc.
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Guest Editorial: The Protein Production Challengeby Roland Andersson and Richard Mynahan, Strategic Decisions Group Protect your revenues and profits from manufacturing scarcity.
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Determining Protein Concentration, Part 1: Methodologyby Nadine Ritter, and John McEntire. Determining protein concentration is one of the most important analytical methods used in the discovery, development, and manufacturing of protein products. Part 1 discusses a number of methods for analyzing samples ranging from complex mixtures to highly purified proteins.
Latest:
Storing an Ion-Exchange Chromatography Gel in Dilute Alkali During Recycling Improves Cleaningby Jane Turton, Central Public Health Laboratory and Zain Moola This case study shows that storing an ion-exchange chromatography gel in dilute alkalai, followed by removal of the solubized material, enhances gel cleaning. More material is removed from the gel during column recycling, and carry over of material from one cycle to the next is substantially reduced.
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TOYOPEARL® AF-rProtein A HC-650FTOYOPEARL AF-rProtein A HC-650F is the most economical protein A resin for monoclonal antibody purification.
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Development of an In Situ Spectroscopic Method for Cleaning Validation using Mid-IR Fiber-Opticsby Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.
Latest:
Development of an In Situ Spectroscopic Method for Cleaning Validation using Mid-IR Fiber-Opticsby Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.
Latest:
Development of an In Situ Spectroscopic Method for Cleaning Validation using Mid-IR Fiber-Opticsby Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.
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Validation of Large-Scale Chromatographic Processes, Part 2: Results from the Case Study of Neuleze Capture on Macroprep High-Sby Timothy N. Breece, Ellen Gilkerson, and Charles Schmelzer, Genentech, Inc.
