Authors
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Unlocking the Value of R&D: Managing the Risksby Duncan Pass, and Martyn Postle, Cambridge Pharma Consultancy How does big pharma look at your biotech company as a potential partner? This often depends on how it looks at its own research and development investments ? and how it presents them to shareholders. This insider's look at biotech-pharma collaboration shows you the other side of the equation.
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Negotiating and Structuring Strategic Alliancesby David Schulman, Dechert London; and Joe Zammit-Lucia, Chris Easley, Cambridge Pharma Consultancy The job of many a biotech CEO is scrambling to find and secure funds to support the company's development projects. For many biopharmaceutical companies in early development stages, collaboration with "big pharma" is a compelling answer to the cashflow problem. But strategic alliances should benefit those on both sides of the negotiating table.
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Criminal Penalties for Theft of Biological Materialby Liz Howard, Orrick, Herrington & Sutcliff, LLP Trade secret theft and economic espionage laws apply to biopharmaceutical researchers. Learn what your company needs to do to retain protection under the Economic Espionage Act and what employees need to know to pretect themselves from criminal charges.
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Outsourcing Outlook: E-Procurement - Reverse Auctions and the Seller's Perspective.by Jim Miller, PharmSource Information Services, Inc. and Edward P. Moser
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Guest Editorial: Enabling Collaboration in the Pharmaceutical Industryby Francois Gossieaux, eRoom Technology, Inc.
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Viewpoint: United Kingdom highlights biomanufacturing capabilitiesby Linda Magee, Bionow The United Kingdom has the second largest biotechnology industry in the world, a leading position in Europe, an excellent science base, proven capability in the development of drug candidates, and a record of several firsts in technology development.
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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.
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Targeted Biomarketing: Helping Biotech Businesses Growby Eric DeRitis, Real PR Network Communicating presents an image of openness, engendering trust; when you don't communicate, people soon think the worst. Biopharmaceutical companies frequently ignore corporate marketing until too late in the game: Public relations should start at inception to help companies start out correctly.
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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.
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Knowledge Management: The Four Pillars of Successby April Davis, Inforonics, Inc. Increasing workplace efficiency, saving time, reducing costs, and retaining, exchanging, and reusing knowledge are a few of the reasons companies introduce knowledge management systems. But, if the four pillars of success ? content, process, culture, and technology ? are ignored, the tools may be shoved to the back of the laboratory closet.
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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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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.
Latest:
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.
